That they held their noses and voted, hoping he would advance their policy priorities and accomplish their goals.

But beneath all this, there is another explanation. One that is more raw and fundamental.

Evangelicals did not support Mr. Trump in spite of who he is. They supported him because of who he is, and because of who they are. He is their protector, the bully who is on their side, the one who offered safety amid their fears that their country as they know it, and their place in it, is changing, and changing quickly. White straight married couples with children who go to church regularly are no longer the American mainstream. An entire way of life, one in which their values were dominant, could be headed for extinction. And Mr. Trump offered to restore them to power, as though they have not been in power all along.

You are always only one generation away from losing Christianity, said Micah Schouten, who was born and raised in Sioux Center, recalling something a former pastor used to say. If you dont teach it to your children it ends. It stops right there.

Ultimately Mr. Trump recognized something, said Lisa Burg, a longtime resident of nearby Orange City. It is a reason she thinks people will still support him in November.

The one group of people that people felt like they could dis and mock and put down had become the Christian. Just the middle-class, middle-American Christians, Ms. Burg said. That was the one group left that you could just totally put down and call deplorable. And he recognized that, You know what? Yeah, its OK that we have our set of values, too. I think people finally said, Yes, we finally have somebody thats willing to say were not bad, we need to have a voice too.

Explained Jason Mulder, who runs a small design company in Sioux Center: I feel like on the coasts, in some of the cities and stuff, they look down on us in rural America. You know, we are a bunch of hicks, and dont know anything. They dont understand us the same way we dont understand them. So we dont want them telling us how to live our lives.

He added: You joke that we dont get it, well, you dont get it either. We are not speaking the same language.

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Christianity Will Have Power - The New York Times

The orders Trump signed would provide an extra $400 in unemployment benefits, suspend some student loan payments and protect renters from eviction. Wochit

WASHINGTON Seeking to tamp down Republican criticism of his new executive orders on the economy, President Donald Trump attacked GOP senator Ben Sasse on Monday as "Republican In Name Only" the same senator who attacked his actions as "unconstitutional slop."

"RINO Ben Sasse, who needed my support and endorsement in order to get the Republican nomination for Senate from the GREAT State of Nebraska, has, now that hes got it (Thank you President T), gone rogue, again," Trump said in a tweet with complex sentence structure.

Sasse used a vivid metaphor todenounce Trump's new executive orders, comparing them to the ones President Barack Obama used to blockdeportation ofchildren of parents who had entered the country illegally.

The pen-and-phone theory of executive lawmaking is unconstitutional slop," Sasse said shortly after Trump signed the orders on Saturday.

Sasse, a member of both the Senate Judiciary and Finance committees, said Obama "did not have the power to unilaterally rewrite immigration law" and Trump "does not have the power to unilaterally rewrite the payroll tax law."

President Donald Trump(Photo: MANDEL NGAN, AFP via Getty Images)

Trump and his aides said they still hope they can reach agreement with Congress on a new stimulus bill to address the economic problems caused by the COVID-19 pandemic.

Sasse and other lawmakers, mostly Democrats, questioned the legality and wisdom of the Trump executive orders that are designed to extend unemployment insurance, prevent evictions, suspend student loan payments, and encourage employers to defer certain payroll taxes through the end of the year.

More: Trump signs executive orders enacting $400 unemployment benefit, payroll tax cut after coronavirus stimulus talks stall

More: 'The Lord and the Founding Fatherscreated executive orders,' says Peter Navarro in defending Trump move

More: 'We have to reach an agreement': Dems, White House open to deal on COVID-19 relief despite Trump's orders

One question is whether there is enough money available to cover Trump's plans, analysts said, and another is whether states and private employers are in a position to help fulfill the plan as requested.

Trump's orders would reduce unemployment benefits from $600 to $400 a week, but it also calls on cash-strapped states to finance 25% of the these costs.

Also, employers are under no obligation to stop withholdingthe payroll tax as called for in the executive orders and legislators in both parties pointed out that those taxes finance Social Security and Medicare, programs they said would be weakened under Trump's scheme.

The orders also do not extend a moratorium on evictions, they only ask government agencies to look for ways to avoid to dislodging renters who have fallen behind on their payments.

There are also questions as to whether any president has legal authority to do any of this, said Sasse and others.

"Under the Constitution, that power belongs to the American people acting through their members of Congress," Sasse said.

Trump has brushed aside these criticism.

"This foolishness plays right into the hands of the Radical Left Dems!" Trump tweeted.

Read or Share this story: https://www.usatoday.com/story/news/politics/2020/08/10/unconstitutional-slop-donald-trump-denounces-gop-senator-ben-sasse/3334538001/

Originally posted here:

'Unconstitutional slop:' Donald Trump spars with Ben Sasse, the GOP senator who attacked his executive order - USA TODAY

Donald Trump has denied that his team ever approached South Dakotas governor about adding his face to the iconic monument depicting four presidents at Mount Rushmore. However, he added that it sounded like a good idea.

The New York Times reported a Republican party official source on Saturday stating that a White House aide reached out to Kristi Noems office with the question: Whats the process to add additional presidents to Mount Rushmore?

Thanks to the angle of some of the photographs taken when Trump visited the memorial in July, it isnt necessary to Photoshop what it might look like. Trump posed in such a way that he effectively added himself as a fifth figure on the monument.

According to reports, the governor had greeted Trump on his recent visit to South Dakota with a 1.2 metre replica of the monument that already included his face as a fifth element.

In a 2018 interview, Noem stated that the two had struck up a conversation about the sculpture in the Oval Office the first time they had met. She claims that she said to him: Mr President, you should come to South Dakota some time. We have Mount Rushmore, and that he replied: Do you know its my dream to have my face on Mount Rushmore?

I started laughing, she said in the interview. He wasnt laughing, so he was totally serious.

The president used the sculpture earlier this year as the backdrop for a showy Independence Day display, which drew protests from Native American activists, who view the monument as a desecration of land violently stolen from them and used to pay homage to leaders hostile to native people. On the night he gave a divisive speech claiming that the US was under siege from far-left fascism.

The four presidents depicted on Mount Rushmore were chosen in the 1920s by the sculptor Gutzon Borglum for their leadership during what were seen then as the four phases of America: George Washington leading the birth of the nation; Thomas Jefferson sparking its westward expansion; Abraham Lincoln preserving the union and emancipating slaves; Teddy Roosevelt championing industrial innovation.

Construction ended in 1941 when funds ran out originally the presidents were designed to be depicted from head to waist.

Trump has previously joked about adding his face to the monument during an Ohio rally in 2017, using it as the basis for an attack on the media. Now heres what Id do, Trump said. Id ask whether or not you some day think I will be on Mount Rushmore. If I did it joking totally joking, having fun the fake news media will say, He believes he should be on Mount Rushmore. So I wont say it.

See the rest here:

Donald Trump denies asking how to add face to Mount Rushmore - The Guardian

The Dow Jones Industrial Average rallied on Monday even amid uncertainty over a new coronavirus stimulus package.

The 30-stock Dow advanced 237 points, or 0.9%. Boeing and Nike were the best-performing stocks in the Dow, rising 4.6% and 4.2%, respectively. Bank stocks such as JPMorgan Chase and Goldman Sachs also contributed to the Dow's gains. JPMorgan Chase advanced 2.1% and Goldman climbed 0.9%.

However, the S&P 500 and Nasdaq Composite struggled as traders trimmed positions in Big Tech stocks. The S&P 500 traded just below the flatline while the Nasdaq slid about 1%. Facebook and Netflix shares slid at least 2% each along with Microsoft. Amazon dipped 1.5% and Alphabet fell 0.9%.

President Donald Trump signed several executive orders over the weekend aimed at extending coronavirus relief.

Those orders continue the distribution of expanded unemployment benefits, defer student loan payments through 2020and provide a payroll tax holiday. However, the unemployment benefit will be continued at a reduced rate of $400 per week. Originally, the benefit provided workers impacted by the pandemic with $600 per week.

"While this move by Trump may lead to legal challenges, politically it puts pressure on Congress to reach a deal," wrote Bill Stone,chief investment officer at Stone Investment Partners.

Trump's moves come after congressional leaders failed to make progress on a new coronavirus stimulus package last week. Several benefits from a package signed earlier in the year lapsed at the end of July, raising uncertainty about the U.S. economy moving forward.

Still, Trump's orders face a legal challenge as continuing the programs would require federal funding, which Congress controls.Democrats have insisted they will not support a bill that does not extend the $600 per week benefit.

On Monday, Treasury Secretary Steven Mnuchin told CNBC's "Squawk on the Street" he is open to more stimulus talks, noting: "We're prepared to put more money on the table."

"The fiscal cliff still represents downside risk for August," said Aneta Markowska, chief financial economist at Jefferies. Markowska added, however, any weakness from this will be "short-lived."

"By September, another round of fiscal support will create positive momentum. The reopening of schools, even if only in some states, will reinforce the positive momentum by (1) boosting back-to-school shopping and (2) allowing more parents to return to work in September," she said in a note to clients. "Bottom line, all the stars are lining up for another inflection point in activity and a second leg up in the reopening."

Wall Street was coming off a strong weekly performance. The Dow rose 3.8% last week for its biggest weekly gain since June. The S&P 500 climbed 2.5% along with the Nasdaq Composite. Last week's gains come during a historically tough time for the market as August kicks off the worst three-month stretch for the S&P 500.

Those gains were led in part by Facebook, Apple and Microsoft, all of which rose by more than 3% last week. They also left the S&P 500 just 1.2% below its Feb. 19 record high.

Investors also kept an eye on the worsening relationship between the U.S. and China. On Monday, China said it would apply sanctions against 11 U.S. citizens including senators Ted Cruz and Marco Rubio. The move is a retaliation against Washington's sanctions on 11 Hong Kong and Chinese officials for curtailing political freedoms in the city.

CNBC's Yun Li contributed reporting.

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Dow jumps 250 points to start week even as White House, Congress battle over coronavirus relief - CNBC

Well, you cant argue with that, O.K.? Whether or not Romney could have taken the Party in a more productive, rational fiscal policy, well never know. I say this in the book, and I think its pretty much inarguable, the idea of so-called trickle-down economics has proved to be nonsense.

Do you think Paul Ryan and Mitt Romney and George W. Bush think its nonsense?

I cant speak for them.

How do you understand his 2012 campaignthat Romney met with Trumpand things like this?

Listen, both those candidates had fifty per cent favorables. Romney got a lot of criticism for not going far enough on stuff. If you go back to the foreign-policy debate, he was criticized for not trying to make Benghazi the center of all evil. In the Republican primary, I remember this well, there was one of those awful raise-your-hand questions: Who believes Barack Obama is a socialist? Mitt Romney was the only person who didnt raise his hand.

He did write a book called No Apology, presenting Obama as some sort of foreign-policy radical.

I think there were huge failures with Barack Obamas foreign policy. I really dont know how anybody would argue with that. You could argue that those failures were inevitable, but you cant look at Syria, the greatest human-rights tragedy in the post-World War Two world, and not think that it was a tremendous, horrible failure. You can sustain two beliefs. I can. One, that Barack Obama is a decent human being, and if Barack Obama were President today the country would be better off. I say that without hesitation, while admitting that there were failures. I think that there was a failure on Obamacare not to be able to come to some greater ability to have both parties support part of it. And probably what we should have done on Obamacare is divide it into pieces. I think its governmentally problematic when you have one party pass it.

He did pass a version of Mitt Romneys health-care plan, but let me ask you, Are you in touch with Romney?

I talk to Senator Romney some. Mainly about books were reading and just stuff going on in mutual friends lives. You know, the impeachment, for example, I had no idea how he would vote. The stuff that I talk to him about is more like personal stuff.

Do you think that Romney or Bush will endorse Joe Biden? Do you think that they should?

I would be very surprised if they do. I think, particularly, for an ex-President the roles that they playI mean, theres a lot of talk about why didnt President Obama weigh in more in the primary. I think it is a unique role that has serious gravity.

I would be very surprised if Senator Romney endorsed him. My experience with Romney is pretty much that on the record and off the record is the same these days. What he said is that he intends to do what he did last time. I think thats what hell do.

Does that disappoint you in any way?

No. I think Mitt Romney has been heroic. I think the eternal shame of most of these Republicans is going to be, why didnt we follow Mitt Romney? I mean, Mitt Romney went out [against Trump] in March of 2016, and, had the Republican Party rallied around him, we could have saved ourselves from this incredible debacle and disgrace and humiliation.

Did you ever figure out what his whole Secretary of State flirtation thing was? Do you think that was just trying to be an adult in the room?

I pretty much know what it was about, because I talked to him then. I think its pretty much what you would thinkthat theres a greater duty to the country, and I think he thought that, out of respect for the office and the process, he should talk to Donald Trump. I think hes very glad that he was never asked to be Secretary of State, because I think it would have been the shortest Secretary of State tenure in history. I dont think he would have lasted two months.

Why are Southerners attracted to Donald Trump?

Its a question Ive asked myself a lot, because in many ways Donald Trump is the caricature of the rich Yankee that were always warned about, who has no manners, no respect for anyone, including women, who is crass, and values money over everything. Thats Donald Trump, and hes pretty much wildly popular with a lot of polite Southerners. I think that there is a perception of Donald Trump as a fighter that appeals to a Southern Scotch-Irish tradition that loves to fight. I think there was a sense that he was politically incorrect and would tell the establishment, Screw you. At the same time, in a lot of these states he did worse than Mitt Romney did. In many ways, Mitt Romney was an unusual fit being a Mormon and also being from Massachusetts. I think that theres a lot of reluctance.

Ive found the Roy Moore thing both the most inspiring and depressing event, because you say, What would it take to get white Republicans to vote for a Democratic moderate? You say, O.K., what if the Republican was a child molester? [In 2018, the Democrat Doug Jones defeated Moore in the race for a U.S. Senate seat, after Moore denied reports that he had made sexual advances toward underage girls in the seventies.] The positive isand not for the first timethat Alabama was saved by African-Americans and saved by, particularly, African-American women. And saved by evangelicals. You know, one of the things that drives me absolutely crazy is we talk about evangelicals and say Trump is popular with evangelicals, and thats not true. Trump is popular with white evangelicals.

Same with the way we talk about the working class.

Exactly.

The Lincoln Project ads have obviously been very effective in getting a lot of press. Do you think that theyre aimed more at lites to signal the Republican opposition to Trump, or are you really trying to get voters to switch? Im not saying the first is necessarily unimportant, but whats the goal?

I think there are multiple purposes here, and I think the purposes are shifting as the Lincoln Project starts spending more money on television. I think, in part, theyve existed to give permission to others to say what needs to be said that isnt being said. Look, Im just kind of a backup singer in the Lincoln Project. It wasnt my creation. Im playing rhythm guitar on this thing. But not having a client is very liberating. You dont have to worry that if you go too far, its going to blow back on your client, because you dont have a client. I think that part of the role that the project has been able to play is to say what people are thinking, but you really cant say that out loud. You say it out loud, and I think thats positive, and I think it moves the needle of discussion. I think that it helps the Biden campaign.

I know that Trumpworld gives every indication of being obsessed with the Lincoln Project, and then its a joke when they attack us. Are you crazy? I mean, were not running for President. Thats a day that theyre not focussed on the Biden campaign.

View original post here:

Why Stuart Stevens Wants to Defeat Donald Trump - The New Yorker

CLEVELAND, Ohio Six people who work at the Bratenahl club that hosted President Donald Trump on Thursday tested positive for COVID-19 coronavirus but were not at the club to encounter the president.

The Cuyahoga County Board of Health and the Shoreby Club each confirmed the positive tests on Friday and offered assurances that the workers posed no hazard to the president.

Any food with which they might have come in contact was discarded, club General Manager Buddy Kane said in a letter to members. The club, meanwhile, was closed Friday and will be sanitized.

The employees were tested Thursday morning off-site as part of preparations for the event. All were asymptomatic, Kane said in the letter to members.

It is unclear yet, though, how many of the employees actually did contract the virus, Dr. Heidi Gullett, medical director for the county Board of Health, said during a Friday media briefing.

The employees were given a rapid positive antigen test, which yields results quickly, but also can yield false positives.

That was the case for Ohio Gov. Mike DeWine, who was scheduled to welcome the president to Cleveland, but instead returned to his home in Cedarville after getting a positive result from that test.

DeWine later tested negative when a more sensitive test called a polymerase chain reaction, or PCR test, which detects genetic material from the new coronavirus, was administered at a Columbus hospital.

Kane, in his letter, said that those who tested positive will also be retested. Gullett, in the briefing Friday, said the six are not counted as confirmed cases at this point.

None were at the event Thursday evening when Trump spoke at the private fundraiser.

The event was Trumps first trip to Ohio since January. Entry started at $5,600 per person. A photo and entry to the reception went for $35,000 and all that plus entry to a roundtable event cost $100,000, according to the campaign posting.

Earlier in the day, at an appearance in Clyde, Ohio, the president tried to soften the blow of the coronavirus pandemic, saying it would be over sooner than people think.

The Trump campaign did not respond to a question about whether anyone attending the event might have tested positive.

Kane, in his letter, said he was meeting with the Board of Health staff for guidance, which the club would follow.

Reporter Seth A. Richardson contributed to this story.

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6 workers at Bratenahl club where Donald Trump appeared test positive for coronavirus, but didnt encounter t - cleveland.com

WASHINGTON In the past few months, President Donald Trump has invited supporters wearing "Make America Great Again" campaign gear onstage with him during official presidential speeches. He has criticized Democratic rival Joe Biden in Rose Garden addresses. He has played campaign-style videos in the White House briefing room, and he has used his campaign playlist, typically reserved for rallies, at official presidential events.

Presidents running for re-election have traditionally worked to balance official government business with campaign activity. But government watchdogs and officials from past administrations warn that Trump has smashed that norm, showing an unusual willingness to use his presidential platform for political purposes.

Trump's penchant for blurring the lines between his campaign and his official duties came to a head last week when he confirmed that he was considering giving his acceptance speech for the Republican presidential nomination one of the most anticipated moments of the election season from the White House South Lawn.

"I'll probably do mine live from the White House," Trump said on Fox News. "The easiest, least expensive and, I think, very beautiful [location] would be live from the White House."

Presidential ethics veterans said the savings weren't his to take. "What Trump is doing is a form of stealing," said Norm Eisen, who was President Barack Obama's special counsel and special assistant for ethics and government reform.

"The taxpayer entrusts funds to the government to do the official business of the government. If they want to support a political candidate, they make a political contribution," he said. "For Trump to effectively be reaching into all of our pockets to subsidize his proposed activity on the South Lawn ... no, the taxpayer should not have to pay for that."

Trump's boundary stretching goes beyond the location of his acceptance speech, Eisen and others said.

The president has increasingly turned official White House events, both in Washington and on the road, into political events as the coronavirus pandemic has kept him off the usual campaign trail and unable to hold large in-person rallies.

Since March, Trump has taken official presidential trips to Pennsylvania, Michigan, Wisconsin, Georgia, North Carolina and Ohio. He has also made multiple visits to Arizona, Texas and Florida. All of those states are critical to Trump's re-election.

"It's always been a fine line that presidents ride with making sure that the official activity in an election year does not go too far into campaign activity," said Kedric Payne, general counsel and senior director of ethics at the Campaign Legal Center, a nonprofit advocacy group. Trump, Payne said, is "barely disguising it as official activity."

On an official government trip to Texas in July, for example, a senior administration official told NBC News that the visit was intended to highlight Trump's energy policy and contrast it with that of Biden's. On another official White House trip in June, to Arizona, the president headlined an event hosted by Students for Trump at a Phoenix church.

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On his most recent presidential trip last week, to Ohio, the White House said Trump was met on Air Force One by a campaign senior adviser in the state, Bob Paduchik. The president held a small campaign-style rally on the tarmac and then visited a Whirlpool factory, where he made fun of Biden ("Did you ever watch Biden, where he's always saying the wrong state?"). He rounded out the journey with a supporters roundtable and a campaign fundraiser.

The trips can become expensive when the airfare and the cost of federally mandated Secret Service protection are taken into consideration.

When a presidential trip involves both official and political events, the White House is supposed to use a formula to determine the amount of money that the campaign or the party should reimburse to the Treasury Department to protect taxpayers from paying for any political activities. The formula generally is not made public.

A spokesperson for the Federal Election Commission said that to distinguish political travel from official travel, the White House should consider the purposes and the natures of the events at each stop.

According to FEC data, the Trump campaign and the Republican National Committee have reimbursed more than $600,000 to the Treasury since May for airfare. Neither the Trump campaign nor the RNC provided NBC News with a breakdown of which trips taxpayers were reimbursed for.

Trump has also officially hosted a number of constituent-based events at the White House since the pandemic hit, involving truck drivers, farmers, veterans and seniors a key voting bloc whose support for the president has slipped amid the pandemic. Five of the nearly two dozen events have been with faith leaders, a demographic that propelled Trump to victory in 2016 but whose support this time around has softened.

The campaign has pushed back against criticism that the president is misusing White House events.

"Democrats and the media are desperate to muzzle President Trump. They don't want him tweeting, they don't want him holding rallies, they don't want him speaking at Mount Rushmore, and now they don't want him holding press conferences," said Tim Murtaugh, the campaign's communications director. "Every week, Joe Biden reads speeches off the teleprompter attacking the president and the media gleefully reports every word, and President Trump is entitled to fight back."

While there are some clear rules governing what sort of political activity the president can engage in on official trips and on the White House grounds (he cannot make fundraising calls from the Oval Office, for example), many of the president's political actions are guided by tradition and norms.

The Hatch Act, a law limiting the political activities that federal employees can engage in to ensure that federal policies are carried out in a nonpartisan fashion and to protect federal workers from political coercion, does not apply to the president.

Officials from previous administrations say decoupling the political from the policy can be difficult, and many relied on White House lawyers, advisers and watchdogs to avoid Hatch Act and ethics violations.

"They were afraid of losing Congress, so they pushed the envelope on a bunch of things," said Richard Painter, a Trump critic who was the chief White House ethics lawyer for President George W. Bush, recalling the 2006 midterm elections, when he frequently had to push back on some actions by administration officials.

Still, said Greg Jenkins, who was Bush's deputy assistant and director of White House advance, "we had a policy that drew a bright line between official and political events."

"All White Houses do events at the White House that advocate or oppose particular policies or proposals. While those are done for political purposes to persuade people to your side they weren't electioneering," Jenkins said.

Download the NBC News app for breaking news and politics

Johanna Maska, Obama's White House director of press advance from 2009 to 2015, said she and other officials would get regular Hatch Act and ethics training from the White House counsel.

Maska said she recalled discussions during the 2012 campaign about whether using Obama's official armored podium with the presidential seal at political events was an example of undue influence and a burden on taxpayers. Ultimately, the campaign decided to buy its own armored podium for Obama to use at events, which, Maska recalled, was expensive.

"Our typical default was we wanted to pay for everything to make sure we were following the law and weren't making any in-kind contributions," Maska said.

Eisen, the special counsel to Obama, said establishing a strict set of rules on the use of Air Force One and reimbursements, among other ethics issues, was a "huge priority" for the administration. "I personally trained everyone in the White House on these rules so they wouldn't break them," he said.

Eisen recalled telling Pete Rouse, a senior adviser to Obama who is an avid Grateful Dead fan, that he had to take down an Obama poster hanging in his office signed by the band because "there can be no taint of politics in this workplace, which is for policy."

Government watchdogs say Trump has strayed far from the ethics norms of past administrations. They say he sets a dangerous precedent that could erode public trust.

"There are all sorts of debates, and the thing I was proud about is that our counsel would challenge us to make sure we were making the best decision for the taxpayers," Maska said. "My question is: What is this counsel doing?"

Original post:

How Trump erased the election-year line between politics and policy - NBC News

When President Donald Trump gave an Independence Day speech at Mount Rushmore in early July, South Dakota Governor Kristi Noem gifted him with a four-foot statue of the famous landmark with one notable addition.

Trumps face was added to it.

According to CNN, though, the President wants more.

It reported that a White House aide reached out to Noem last year to inquire about possibly adding Trumps face to the landmark.

Its not possible, according to Business Insider, because theres no stable surface left for carving a fifth face.

But, according to the reports, its a dream of Trumps and its something he has brought up more than once. In fact, Noem told South Dakotas Argus Leader, he mentioned it during their first meeting in the Oval Office.

He said, Kristi, come on over here. Shake my hand, she said. I shook his hand, and I said, Mr. President, you should come to South Dakota sometime. We have Mount Rushmore. And he goes, Do you know its my dream to have my face on Mount Rushmore?

Noem said she started laughing.

He wasnt laughing, she said. So, he was totally serious.

Original post:

Donald Trumps face on Mount Rushmore? Reports say White House inquired about the possibility - PennLive

Supporters and protesters lined the streets to greet President Trump during his visit to Long Branch for a fundrasier on Aug. 9, 2020. Asbury Park Press

LONG BRANCH President Donald Trump arrived here shortly before 5 p.m. for a private fundraising event on Ocean Avenue.

Marine One, the helicopter that transports the president, touched down at Elberon Park at 4:47 p.m. A motorcade then escorted Trump to a private home on Ocean Avenue in the city's Elberon section. The home belonged to the lateStanley Chera, a friend of Trump's who died in April due to complications of COVID-19.

Admission to the fundraiser cost supporters between $5,600 and $250,000, with perks including photo opportunities and a seat at a roundtable discussion with the president.Trump departed the event shortly after 7 p.m.

In a video tweeted out by Jewish Insider, Trump promises the sitting crowd of supporters some of whom rise to their feet that the White House will reach some sort of agreement with Iran within a month of Election Day if he wins re-election.

"If we win, we will have a deal with Iran within four weeks," he says in the video.

Tensions between the U.S. and Iran have gradually increased since Trump withdrew the United States from a 2015 nuclear deal and reimposed sanctions that restricted Iranian oil exports and brought the Iranian economy to a halt. In January, a U.S. drone strike killed Iranian general Qasem Soleimani in Baghdad.

Iran responded by firing ballistic missiles at U.S. forces in Iraq.

On Friday, National Counterintelligence and Security Center director William Evanina said Iran "seeks to undermine U.S. democratic institutions, President Trump, and to divide the country in advance of the 2020 elections.

Other videos from the fundraiser show Trump and the crowd being blessed by a group of rabbis, as well as his introduction by Haim Chera son of Stanley Chera.

In one video tweeted by Jewish news website Belaaz, Haim Chera refers to Trump as "the greatest president in our country's history" and thanks him for his friendship after his father's death.

In the video, Haim Chera also propulgates a popular conspiracy theory that the COVID-19 may have been "maliciously released" by the Chinese government.

None of the fundraiser guests, who appear to be packed in under an outdoor tent, appear to be wearing face coverings in the video.

"You are fighting a war against an invisible enemy, recklessly or maliciously released onto our shores from China, and you still made time to offer your assistance to us," Haim Chera said in the video.

Opponents and supporters of Trump gathered on Ocean Avenue, about one block south of the Chera compound, where a pair of heavy-duty green and gray public works trucks served as a barricade.

At 2 p.m., hours before Trump's anticipated arrival, protesters for and against his administration squared offoneither side of South Lincoln Avenue, trading chants "Dump Trump!" and "Four more years!"

Supporters and protesters gathered in Elberon on Sunday, Aug. 9, and begun marching to Ocean Avenue where, sometime before 5 p.m., President Donald Trump is expected to arrivefor a fundraiser with New Jersey supporters.(Photo: Mike Davis/Asbury Park Press)

"They have their own fundraiserdown the road. What do they need us for," said Summitresident Jill LaZare, aDeal native and former Assembly candidate who organized the anti-Trump protest.

WHAT WE KNOW: President Trump schedules fundraiser in Elberon

"A lot of these people have been yelling 'we don't want you here,' and I want to make sure it's clear that there are a lot of people in this area who do not support Trump, and are outraged by his presidency on so many different levels," LaZare said.

LaZare and about 50 other protesters were gathered on a small field on one side of the street, flanked by the infamous "Baby Trump" balloon, a caricature of the president that has made appearances at various protests and events over the last few years.

Jack Gavin drove to the protest from his home in West Caldwell to help set up the Baby Trump balloon and pass out pocked-sized copies of the Constitution, a practice he said was inspired by Gold Star father Khizr Khan, who offered to lend Trump a copy at the 2016 Democratic National Convention.

Its an important thing to educate everyone I can about what the Constitution says and does not say and the importance of it especially when it comes to checks and balances, Gavin said. Donald Trump is walking all over checks and balances and the Republican Senate is doing nothing to stop it.

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At 4 p.m., police told protest organizers to take the balloon down at the order of the U.S. Secret Service, LaZare said.

On the other side of the street were about 25 counter-protesters, stacked two or three deep and waving an American flag, a "blue line" flag and a Trump 2020 campaign flag.

Rafi King, a police chaplain, spent the first half-hour chanting "Trump 2020" and "blue lives matter" into a megaphone before police instructed him to put it away. LaZare said her group wasn't allowed to use one, and asked police to enforce that rule on the counter-protesters.

Supporters and protesters gathered in Elberon on Sunday, Aug. 9, and begun marching to Ocean Avenue where, sometime before 5 p.m., President Donald Trump is expected to arrive for a fundraiser with New Jersey supporters.(Photo: Mike Davis/Asbury Park Press)

There were hints of outrage, but never violence. Anti-Trump protesters swarmed a luxury car, with New York plates, exchanging obscene hand gestures after unknown words were exchanged.

Vic Hara, 61, of Oakhurst said he voted for Trump in the last election and would do so again. Hara, who is Jewish, also supports the presidents pro-Israel actions.

He shows respect for the country, he said. We were losing ourrespect as a country.

My man Donald Trump, I supported him in the last election. Im supporting him in this election," said another Trump supporter, Ray Antoky, 73, of Long Branchs West End section. "He made America great again, and hes going to do it again.

Trump supporters Vic Hara, of the Oakhurst section of Ocean Township (left) with Ray Antoky , of Long Branchs West End, on Ocean Avenue in Long Branch ahead of the president's visit on Aug. 9, 2020.(Photo: Amanda Oglesby)

Antoky said he likes Trumps fight against the Deep State and fake press. The president cares about employment and people, he said. Antoky, who is Jewish, said he likes Trump for being pro-Israel.

And one anti-Trump protester made the mistake of arriving at the protest on the wrong side of the street. The crowd of pro-Trump protesters swarmed her, at one point ripping one of her homemade posters in half.

They ripped it up, said the woman, a local resident who declined to give her name. That was uncalled for. There was no reason for him to do that.

The anti-Trump protesters displayed hand-written signs while the pro-Trump group waved the American flag, along with a blue lives matter and Trump 2020 campaign flag.

Chera, 77, had relocated to his Elberon home in late March but was admitted to New York Presbyterian Hospital with the novel coronavirus a short while later. He died on April 11.

When you send a friend to the hospital, and you call up to find out how is he doing it happened to me, where he goes to the hospital, he says goodbye, Trump said during a March press briefing, referring to Chera. "And you call up the next day: 'How's he doing? And hes in a coma? This is not the flu.

In Elberon, barely any of the pro-Trump protesters was wearing a face mask, despite both doctors encouragingand state law requiring people to doo so in order to curb the spread of COVID-19.

Their unencumbered chants ofget a job and four more years" occasionally drowned out the "dump Trump" and "show me what democracy looks like" chants of the masked anti-Trump protesters, who instead displayed their hand-made posters.

"162,000+ dead," one sign read. "Are we winning?"

Mike Davis has spent the last decade covering New Jersey local news, marijuana legalization, transportation and basically whatever else is going on at any given moment. Contact him atmdavis@gannettnj.comor@byMikeDavison Twitter.

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Trump to Long Branch fundraiser crowd: 'Deal with Iran within four weeks' if-relected - Asbury Park Press

Scott Morrison says he has pressed Donald Trump for help to prevent the release of an Afghan man who was convicted of murdering three Australian soldiers in Afghanistan.

The prime minister said the Australian government would continue to push as hard as we can for the continued detention of the former Afghan soldier known as Hekmatullah, after reports he could be released as a result of peace negotiations between the Afghan government and the Taliban.

Hekmatullah was convicted of murdering three Australian soldiers Corporal Stjepan Milosevic, Private Robert Poate and Sapper James Martin as they played cards at a patrol base north of Tarin Kowt in August 2012.

Australian defence officials contacted the families of the three Australians late last week to inform them Hekmatullah was likely to be one the 5,000 prisoners set to be released after prisoner swap negotiations, the ABC reported.

Morrison told reporters in Canberra on Monday that he had raised the issue directly with the US president. He said the defence minister, Linda Reynolds, and the foreign affairs minister, Marise Payne, had also raised the issue with their American counterparts at the Ausmin talks in Washington late last month.

This has been a matter of very regular and persistent petitioning on our behalf, the prime minister said.

It is a matter that Ive written to the president about. It is a matter of keen interest to Australia and weve reminded them of that.

Morrison said Hekmatullah was responsible for murdering three Australians and our position is that he should never be released. Morrison argued such a release would not contribute to regional peace.

That is the position that we will continue to maintain and well maintain it strongly, he said.

I cant promise you the outcome we all want here, but it is certainly the outcome we will continue to press for as hard as we can.

The families issued a joint statement to say the news came as a crushing blow and that they believed Hekmatullah should have been executed in line with the sentence issued by the court in Afghanistan, the Australian newspaper reported.

Poates father, Hugh, told the newspaper the news of the likely release was like deflating a balloon.

Hekmatullahs potential release stems from a peace agreement between the US and the Taliban that was reached in February this year.

The US secretary of state, Mike Pompeo, said last week that the release of prisoners was unpopular but it would lead to a reduction of violence and direct talks resulting in a peace agreement and an end to the war in Afghanistan.

Under the February agreement, the US committed to work with all relevant sides on a plan to expeditiously release combat and political prisoners as a confidence-building measure with the coordination and approval of all relevant sides.

It flagged the release of up to 5,000 Taliban fighters in return for the release of up to 1,000 government security forces. According to the text of the agreement, the Taliban committed that its released prisoners will be committed to the responsibilities mentioned in this agreement so that they will not pose a threat to the security of the United States and its allies.

The deal also included a commitment to withdraw from Afghanistan all military forces of the US, its allies, and coalition partners. There have been some difficulties and delays in implementing the prisoner release aspect of the deal.

Hekmatullah went on the run after the fatal attack on the Australian soldiers but was captured in Pakistan in February 2013 about six months later and then brought to trial in Afghanistan.

In 2013, an Australian Defence Force inquiry found there was a failure to provide appropriate force protection at the Wahab base where the soldiers were killed despite sufficient resources being available.

A Queensland coroner who also investigated the deaths found that an order from headquarters to increase security at patrol bases had not been passed down to troops on the ground.

The opposition leader, Anthony Albanese, said news of the potential release would be a source of great distress for the families of the victims.

This is a critical issue for the families but also for justice, Albanese said.

This man should not be released, and Australia needs to make the strongest possible representations to both the Afghan government and to the United States to ensure that this doesnt happen.

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Scott Morrison presses Trump for continued detention of ex-Afghan soldier who killed three Australians - The Guardian

BEDMINSTER, NEW JERSEY - President Donald Trump acted Saturday to extend an expired jobless benefit to tens of millions of Americans who have lost their jobs during the coronavirus pandemic and defer payroll taxes after negotiations with Congress on a new package of economic aid collapsed.

As the United States neared 5 million cases of the coronavirus and 162,000 deaths Saturday, Trump called for up to $400 extra in weekly unemployment payments, one-third less than the $600 people had been receiving. Congress allowed those payments to end August 1, and talks to extend them fell apart Friday, with the White House and Democrats far apart on relief aid.

"This is the money they need, this is the money they want, this gives them an incentive to go back to work," Trump said of the smaller jobless benefits during a news conference at his private country club in Bedminster, New Jersey.

He said 25 percent of it would be paid by states, whose budgets have been hard hit by the crisis. The president wants to set aside $44 billion in previously approved aid to help states pay the larger jobless benefits, but it would be up to states to decide how much, if any, to use, so the benefits could be smaller still. The previous unemployment benefit was fully funded by Washington.

"Donald Trump is trying to distract from his failure to extend the $600 federal boost for 30 million unemployed workers by issuing illegal executive orders," Oregons Sen. Ron Wyden, the top Democrat on the Senate Finance Committee, said. "This scheme is a classic Donald Trump con: playacting at leadership while robbing people of the support they desperately need."

Payroll taxes

The president is also suspending payroll taxes for workers who make less than $100,000 through the end of the year. Unemployed workers, who do not pay the tax because they arent collecting a paycheck, wont benefit. The taxes, 7 percent for employees, pay for Medicare and Social Security and will need to be paid eventually unless Congress acts, but there is bipartisan opposition to this on Capitol Hill.

"This fake tax cut would also be a big shock to workers who thought they were getting a tax cut when it was only a delay," Wyden said. "These workers would be hit with much bigger payments down the road."

Finally, the president said he was extending protections for tenants threatened with eviction and further delaying student loans payments and zero percent interest on federally financed loans.

Democratic presidential candidate Joe Biden called the orders a "series of half-baked measures" and accused Trump of putting Social Security "at grave risk" by delaying the collection of payroll taxes that pay for the program.

However, Senate Majority Leader Mitch McConnell said in a statement Saturday, Struggling Americans need action now. Since Democrats have sabotaged backroom talks with absurd demands that would not help working people, I support President Trump exploring his options to get unemployment benefits and other relief to the people who need them the most.

At an impasse

Negotiations between top congressional Democrats and the White House reached an impasse after nearly two weeks with the two sides about $2 trillion apart.

Speaker of the House Nancy Pelosi and Senate Minority Leader Chuck Schumer had offered to cut their $3.4 trillion aid package by almost one-third if the Republicans would double their $1 trillion counteroffer. That $1 trillion package faces opposition by about 20 of the Senates 54 Republicans.

Todays meager announcements by the President show President Trump still does not comprehend the seriousness or the urgency of the health and economic crises facing working families, Pelosi and Schumer said in a statement Saturday.

These policy announcements provide little real help to families. Furthermore, these announcements do nothing to increase testing, nothing to reopen schools, nothing to put food on the table for hungry families, nothing to prevent heroes being laid off across state and local government, nothing to protect the Postal Service or the integrity of our elections, nothing on many critical needs of the American people.

The breakdown in the negotiations between the White House and congressional Democrats is particularly distressing for schools, which have been counting on billions of dollars from Washington to help with the costs of reopening. But other priorities, not addressed in Trumps actions Saturday, are also languishing, including a fresh round of $1,200 direct payments to most people, a cash infusion for the struggling Postal Service and money to help states hold elections in November.

Four coronavirus rescue bills amounting to nearly $3 trillion all won bipartisan approval, but conservatives have recoiled at the prospect of another agreement with a whopping deficit-financed cost.

Originally posted here:

Trump Takes Executive Action on Economic Relief Package - Voice of America

Nobody likes me.

Truth or Consequences is the name of a town in New Mexico, and of a game show dating from the 1940s. But its also one of the primal laws of existence. Where an important truth is denied, consequences follow.

So none of us can be surprised at the state of the union after seven months of Donald Trumps lies, alibis and magical thinking in the face of one of the worst public health crises in history. Almost 160,000 of us are dead, the U.S. economy just endured its worst quarter on record and there is no sign the disaster is going to abate any time soon. To the contrary, the federal government is adding to the list of red zone states i.e., states where the COVID-19 infection rate continues to climb. Twenty-one states nearly half the country now make the list, including Florida, Tennessee, Texas and Mississippi.

And it should be lost on none of us that the red zone states are also mostly red states. Nineteen of the 21 California and Nevada are the outliers went for Trump in 2016. Red states, not to put too fine a point on it, are those wed expect to be most susceptible to his lies, alibis and magical thinking and most resistant to masks and social distancing.

Again, this is no surprise. As has been noted repeatedly in this space, truth doesnt care about your feelings. Unfortunately, Trump doesnt care about truth, so on behalf of 330 million of us, he chose consequences instead. And this country will be years in recovering, if it ever does.

All of which lends to a sense of astonishment at the morose monologue quoted above. It came during a news conference, called ostensibly to provide an update on the nations fight against the coronavirus pandemic. But the briefing also offered a squirm-inducing glimpse into Trumps fragile psyche as he ruminated over the fact that Dr. Anthony S. Fauci, the face of his coronavirus task force, is more popular than he is.

It sort of is curious, Trump said. A man works for us and yet theyre highly thought of and nobody likes me. It can only be my personality. And Lord, what to say about that?

It was pathetic, the miserableness of an unloved boy poking through the braggadocio of a 74-year-old man.

It was amazing, this most reality-resistant of men publicly conceding this most humiliating of facts.

It was sickening, almost 160,000 people dead, the nation in chaos, and yet, he cant see beyond his own envy.

And it was revealing, testament to a failure of self-awareness more epic than Greek tragedy.

Consider that shortly before the briefing, Trump retweeted the crackpot theories of some woman who claims, despite expert consensus to the contrary, that hydroxychloroquine can cure COVID-19. Mind you, she also believes doctors use alien DNA to treat patients, and researchers are creating a vaccine to stop people from being religious.

Called on his decision to amplify this woman, Trump insisted she is very respected. And also that I know nothing about her. Yet he muses that nobody likes him and it must be his personality?

Well, yeah. That, his imbecility and his utter inability to feel or even fake compassion for other human beings.

Nobody likes me. Boo hoo.

He denied the truth, and thats one of the consequences. Here are some of the others: People are sick, people are dying, people are losing their homes, people are losing their businesses, the country is unraveling. So Trumps operatic self-pity is a bridge way too far.

If anyone has compassion to spend, there are 330 million people who deserve it more.

Excerpt from:

Here are 160000 reasons why nobody likes Donald Trump - Lewiston Morning Tribune

This is the kind of stuff that confuses people.

What won't help is the major delay in results for some primary races in New York, people not receiving ballots for Tuesday's primary in Michigan and other snarls and hiccups we've seen through the primary season.

Colorado, Washington and Oregon have conducted vote-by-mail elections in the past. Hawaii and Utah had planned to hold a vote-by-mail election before the pandemic struck.

I talked to Elaine Kamarck, a senior fellow at Brookings and the founder of their Center on Effective Public Management.

Our conversation, conducted by phone and slightly edited for flow, is below.

Suppressing his own vote!

WHAT MATTERS: What's the first thing people need to know about the current debate over mail-in voting?

KAMARCK: People including the President until recently conflate what are called universal mail-in ballot states with absentee ballot systems.

There are only seven states in the United States that are going to use universal mail-in ballots for the November election.

They are Washington, Oregon, Utah, Colorado, California, Hawaii and the District of Columbia. All the ones we give As to.

First of all, the President has gotten into his head that somehow these states are corrupt and this system is corrupt. Not one of these states has had an allegation of corruption. Not one. Oregon has used this for 20 years and hasn't had a contested election, so I don't know where the hell he's getting that from.

The rest of the states in the union have absentee ballot provisions. Every state has absolutely valid provisions And as you saw from our map some are easier to access than others. That's why we graded them from A to F.

What he's doing is he's suppressing his own goddamn vote! It's just the stupidest thing I have ever seen in my life.

Be ready for election night to last a month

WHAT MATTERS: What's one thing everyone needs to be ready for as a result of all the mail-in voting?

KAMARCK: It sets us up for a very long election night or election week.

Because what's going to happen is the vote on election night may or may not -- probably will not -- be reflective of the total vote ...

Twenty states are now accepting absentee ballots that arrive as late as 10 days after Election Day.

So in other words, they have to be postmarked on Election Day. But if they arrive five days, six days, seven days later, they're going to be counted.

And this, this is a new wrinkle. Usually you have 1 to 5% of ballots are absentee ballots. Usually it doesn't make a difference in the outcome of the race. ... My guess is we're going to have 50% absentee ballots. That's my estimate from what happened in the primaries, is we're going to 50/50.

Can the states handle this?

WHAT MATTERS: Is the US able to handle a massive uptick in vote by mail?

KAMARCK: Yes it is. And the reason it is is that every state has had a practice run in the primary.

So they are working hard on this. Now, handling it now it may take longer to count these things, but they are able to handle it.

KAMARCK: We looked at a series of variables that all related to ease of voting absentee. And, for instance, there were some states that require you to have a notary notarize your absentee ballot. Well if there's no need to do that -- and obviously as you can imagine tracking down the notary is a big pain in the neck whenever you have to do it and that's very bad -- that definitely cuts down on absolutely valid use. Many states are moving away from that. There's only a handful of states that do that. But we took points off.

We had a point system, we took points off if you had to have a notary. And we gave points if all you needed was the signature of a registered voter.

Is the system safe?

WHAT MATTERS: How is the system secure if it simply requires a signature?

KAMARCK: States match signatures. They've got a signature on your voter registration, which they keep on file. Some states actually have technology that matches signatures ...

And this is another place where Trump is out of his mind. The ballots are usually printed county by county. They're on specific kinds of paper. They're in a specific format. Sometimes they've got barcodes on them. In other words, the notion that somebody could go out and massively create a bunch of fake ballots and send them to fake voters who weren't real people who didn't have signatures that matched their voter registration. That's really hard ...

So this whole notion that this is vulnerable to fraud just doesn't hold water.

Prior to the pandemic the biggest worry about our election apparatus was that Russians or other foreigners would hack into the election systems and alter the vote.

Ironically, before the election, 22 states had moved to adopt paper ballots so that there could be a verifiable paper trail in the case of a recount.

As we move now to all absentee ballots, essentially we have a really, really good paper trail because it's an absentee ballot with a signature, etcetera etcetera.

It's hard to hack into that. Absentee ballots are counted in large rooms, which are secured by guards in the state capital or the state election board headquarters. So Boris may find it easy to hack into the transmission of results. He's not going to find it very easy to get in the damn room where they're counting the ballots.

Who is allowed in that room? Election officials and a representative of each political party.

It's not like, you know, they're going to let the Republican in the room and keep the Democrat out, right?

Those representatives of political parties are usually lawyers and they are armed to the gills to run right to court. And they're gonna run right to court the minute anything funny shows up.

This will not be flawless

WHAT MATTERS: In Michigan, in New York, in Connecticut and elsewhere, vote by mail has not been flawless in the primary process. Should people be worried about those problems that we've seen with ballots not arriving on time, or should they just accept that as a part of the new system?

KAMARCK: Well I think the answer is yes and no. The bad news is that every state is going to be going through a volume of ballots that they've never had before. So for many, many states this is going to be all brand new and stuff is gonna happen, right? There will be ballots that are arriving late, etcetera ...

The good news is that the the primaries were a dry run. And states learned things in the primaries. One of the most important things they learned is that ... you have to have some sort of backup system.

Provisional ballots. In some states, the people realize you need to have more in-person voting places than they thought they needed. So say you apply for your absentee ballot and you don't get it by Election Day.

You need to be able to go to a polling place and vote, and one of the things that happened in so many states in the primaries was that they didn't have enough polling places because they saw the volume of absentee ballot requests and then they thought, 'Oh we don't need a lot of voting places.'

Well it turns out they maybe didn't need as many as they usually do. But they needed a heck of a lot more than they had because people ... who didn't get their ballots wanted to go vote in person.

Let's say Covid had just hit in August. Then we really wouldn't be very prepared for this. At least we're a little bit better prepared.

Can the US Postal Service handle this?

WHAT MATTERS: What's your assessment of whether the Postal Service can deal with this deluge of ballots?

KAMARCK: I think it will be slow. I think there will be -- it'll take time to get ballots in.

I think a lot of people who know who they're going to vote for are going to vote early to make sure that their ballot gets in.

The second thing we see states doing -- and we're up 20 states now -- they are accepting valid ballots after Election Day. And that is specifically to account for this problem. ... And we gave them good grades obviously for doing that.

So that's one adjustment. My expectation is that more states are gonna adopt that so that if the mail is slow, they'll still get their ballots counted.

Election Day starts in one month

KAMARCK: Well it's too late for North Carolina. But no, it's not too late for states to make changes. And one of the reasons we're updating our score card every Friday is because states are in fact making changes, you know, as we speak. I'd say there's probably another month or so for states to make changes and then it's pretty locked in.

The other thing that's going on by the way is there are a lot of court cases. So the Republican National Committee has been fighting this, trying to follow in Trump's footsteps, although they've not been very successful. ... I think the courts need to act expeditiously and make decisions here so that come around Labor Day everybody knows how to vote in their given state.

The media's special responsibility

WHAT MATTERS: Is there anything else you think people need to know?

KAMARCK: I'll tell you this one last thing.

I think it is very important that the media not set expectations that we're gonna have everything decided on election night.

Because frankly, if they try to call this too fast and then the absentee ballots change and the outcome changes in some state or the election is close, then it plays right into the hands of the conspiracy theorists, including the President, who is trying to argue that the election is going to be wrecked and incorrect.

And so the media plays a big role here ... the worst thing the media can do is jump to conclusions. If it's really clear, if it's a landslide, then they probably can call it on election night. But short of that, they've got to be really careful about calling the election.

Originally posted here:

Trump may finally realize he's suppressing his own vote - CNN

With less than three months to go until Election Day, Donald Trumps campaign this week tried again to hit the reset button. Were going to run like were the underdog, Trumps new campaign manager, Bill Stepien, told Fox News on Monday. Before Stepien spoke, the Trump team released two new television ads targeting Joe Biden, who, thus far, has proved an elusive foe. One features a montage of Biden with Senator Bernie Sanders and Representatives Alexandria Ocasio-Cortez and Ilhan Omar, and claims that Biden has embraced the policies of the radical left. The other shows a woman of color silently holding up printed cards, the last two of which say IM AFRAID TO SAY THIS OUT LOUD I WONT RISK MY CHILDRENS FUTURE WITH BIDEN.

These ads seem to have come from the same playbook that Trump has been relying on for months now, with little success if you believe the polls. To get a better idea of how the campaign is trying to motivate the Presidents loyal supporters and reach out to less committed ones, I downloaded the campaigns official app, which promised to supply me with exclusive content and campaign updates. For a couple of days, I dived into the online Trump world, which turned out to be an immersive experience.

After registering, I was immediately invited to sign up and watch some of the apps proprietorial video content, including Triggered, a show that features the Presidents son Donald Trump, Jr., and Theology Thursday with Speaker Gingrich. As I waited for these examples of must-see viewing to begin, I watched another show, which had been recorded a few days previously. The Right View is the Trump campaigns version of The View, the popular daily talk show that airs on ABC. The four hosts were Lara Trump, the Presidents daughter-in-law; Kimberly Guilfoyle, a former prosecutor and Fox News host who is dating Donald Trump, Jr.; Katrina Pierson, a Tea Party activist who was a spokesperson for Trumps 2016 campaign; and Mercedes Schlapp, a Republican communications operative who served in the Trump White House from 2017 to 2019.

What the hosts lacked in objectivity, they more than made up for in vitriol toward Biden and the Democrats. Its really horrifying to see what these people are doing, Lara Trump said, in reference to Democratic efforts to expand mail-in voting in Nevada and other states. After conducting an interview with Kaya Jones, a conservative pop singer, the hosts then discussed the Trump campaigns two new ads, while carefully omitting how misleading they are. (One of the ads claims that Biden supports defunding the police and raising taxes on the middle class. He backs neither.) The hosts repeatedly tore into the Democratic candidate. They will go to any lengths possible to try and prop up Joe Biden, like a Weekend at Bernies skit, Lara Trump said. They cant be real thinking this guy can be President, Guilfoyle said. He cant find his own way out of his home. The socialists who controlled Biden were hoping to use him as a tool to advance their radical agenda and tear this country apart, she went on.

Things continued in this vein for close to fifty minutes, interspersed by pop-up ads offering Trump merchandise, such as a MAGA Mama T-shirt. The show was slickly produced, and it captured the essence of the Trump campaign, which has come down to employing scare tactics, many of which are racially coded; claiming Biden is mentally impaired; and trying to suppress the Democratic vote by challenging mail-in voting and other efforts to insure that an election during a pandemic can be held safely and fairly. Notably absent from the episode of The Right View that I watched was any serious discussion of the coronavirus, which has claimed more than a hundred and sixty thousand American lives, or any real defense of Trumps record. Evidently, the Trump campaign doesnt like its chances if the election turns into a referendum on its candidates performance in office. So its doing all it can to change the subject.

That approach is also clear in the campaigns Facebook ads, which are just as voluminous as they were in 2016. Dangerous MOBS of far-left groups are running through our streets and causing absolute mayhem, one says. Joe Biden has ABSOLUTELY lost his mind, another proclaims. Between early May and August 6th, the Trump campaign spent $60.2 million on Facebook, while the Biden campaign spent just $29.5 million, according to Facebooks own records. Some of this difference was offset by spending by Democratic groups that are not directly under the control of the Biden campaign, such as the Priorities USA super PAC. But just as it did in 2016, the Trump campaign is placing a great deal of emphasis on Facebook for fund-raising and reaching persuadable voters.

That doesnt mean its neglecting more traditional campaigning methods, such as canvassing and conducting voter-registration drives. At a moment when the Biden campaign has largely abandoned physical efforts to contact voters because of the pandemic, relying instead on phone calls, texts, and digital outreach, the Trump campaign and the Republican National Committee have recruited mask-wearing canvassers, who they claim are knocking on more than a million doors a week. From now to Election Day, voters may only see one campaign at their doors, Elliott Echols, the R.N.C.s national field director, told Politico. We can do this safely for President Trump and Republicans up and down the ballot.

Republicans have also made extensive efforts to register new G.O.P. voters, particularly in some key battleground states. In Pennsylvania, for example, Republicans have added about 165,000 net voters, while Democrats added only about 30,000, since 2016, the Philadelphia Inquirer reported last week. Democrats still maintain an 800,000-voter edge over Republicans. But thats down from 936,000 in 2016, when Trump still won the state by less than 1%.

Despite all these efforts, the polls show Trump trailing Biden, as they have all year. In FiveThirtyEights poll average, the margin between the two candidates on Saturday morning was 7.8 percentage points. Thats down a bit from the nine-point advantage that Biden held a couple of weeks ago, but it still represents a substantial gap. Trump is also trailing Biden in most of the battleground states, including Michigan, Pennsylvania, and Wisconsin, which he won narrowly in 2016 to put together a majority in the Electoral College.

During his interview with Fox News, Stepien sought to downplay the public polls, pointing out that most of them had Trump behind in 2016, as well. He also claimed that the campaigns internal polls show a strong standing for the President. Some of the campaigns recent actions suggest otherwise, though. After putting television ads on hold last month, when Stepien replaced Brad Parscale as campaign manager, this week it resumed advertising in Arizona, Florida, Georgia, and North Carolinaall states that Trump won in 2016, but where polls currently show him trailing or in very tight races with Biden.

The latest ad buy is just the beginning. Both campaigns have raised obscene amounts of moneyearlier this week, the Trump campaign announced it had more than three hundred million dollars in the bank, and Bidens said it has nearly two hundred and fifty million. Between now and November 3rd, anybody who lives in a battleground state is going to be blitzed by political ads from both parties, on all of their devices. With so many ads running, they are likely to cancel each other out, at least to some extent. Trump may well need something more seismic to shift things in his favor.

See original here:

The Trump Campaign Tries to Change the Subject - The New Yorker

Problem: Development and trials of new coronavirus treatments may take anywhere from four to seven years. But millions of patients need treatment here and now. Doctors are looking for effective medications (or combinations of medicines), blindfolded. Meanwhile, chemists can predict which existing medications are potentially the most effective.

Solution: Russian researchers have created a special method of molecular modeling called on-top docking. They used it to explore the whole surface of a protein that is vitally important for SARS-CoV-2 and compared it to a number of known medications. They discovered that two drugs are potentially able to switch off the enzyme and stop the coronavirus reproduction. One of them is used to treat alcohol addiction, and the other is for cancer.

A team of chemists from HSE University and the Zelinsky Institute of Organic Chemistry used molecular modeling to find out that two medications that have been known for a long time can be used to fight SARS-CoV-2. These are disulfiram, which is used to treat alcoholism, and neratinib, an experimental drug being used to treat breast cancer. Both drugs are potential covalent inhibitors of the SARS-CoV-2 virus main protease Mpro a key enzyme responsible for SARS-CoV-2 replication (copying its genetic material and building the new virus particles). The paper about the discovery was published in the July issue of Mendeleev Communications journal.

A coronavirus was first detected in a patient with acute respiratory infection long ago, in 1965, but it was only about two decades ago that humanity faced really dangerous representatives of this family. Unfortunately, since the first SARS-CoV epidemic didnt leave Asia (mostly, China) in 2002-2004 and the MERS outbreak in 2012-2015 seriously affected only Saudi Arabia and Korea, the global pharmaceutical industry has made virtually no effort to develop effective treatments for coronaviruses. Tests and medications have been actively developed almost exclusively for the needs of veterinary medicine.

Broad-spectrum medicines were used during previous epidemics, but the experience of medics in Chinese Wuhan demonstrated that this was not enough. Clinicians around the world have risked trying various experimental protocols, with the use of medicines used to treat HIV (lopinavir and ritonavir), malaria (chloroquine and hydroxychloroquine), and other diseases. But they were looking for the drugs being effectively blindfolded.

The global pharmaceutical industry was caught unaware, and there was no time to create brand new medicines. Even if potentially effective substances are detected, their preclinical and clinical trials would take from four to seven years. Thats why the most reasonable solution has been to search among known drugs that have proven to be safe for human health. This path repurposing medicine has been effectively used for a long time. The only problem is: how do we learn whether they are able to fight the coronavirus?

Computer modeling can help. This approach is called in silico similarly to in vivo (in a living body) and in vitro (in a test tube). It allows numerical models to be used to test hundreds of various medications and determine their potential effectiveness and the mechanism of action. Chemists at HSE University and the RAS Zelinsky Institute of Organic Chemistry have been carrying out such research for many years. In 2014, they modeled a leukemia treatment, and in 2017, a treatment for rheumatoid arthritis. With such a background, the researchers jumped into the search for a SARS-CoV-2 treatment in 2020.

The coronavirus, like many other viruses, mutates quite quickly. Its genome contains about 30,000 nucleotides specific building blocks of the genetic code. On average, one mutation, or more precisely, one SNP (single nucleotide polymorphism) happens in a virus RNA once every two weeks. This means that new strains of SARS-CoV-2 appear regularly. In Russia alone, there are nine unique SARS-CoV-2 lineages that are not present in other countries.

This is why the structural elements of the virus that are less subject to mutation during its evolution should be chosen as a target for the potential treatment. Otherwise, a medication effective against one strain would no longer be effective against another. The best candidates for this are conservative proteins, such as theSARS-CoV-2 virus main protease Mpro.In addition to being resistant to mutations, Mproplays a major role in coronavirus replication, which means that its inhibition (blocking its function) is able to slow down or even completely stop its reproduction inside the body.

Usually, the process of docking, as with a port dock and a ship entering it, is used for molecular modeling in simple cases. Two molecules participate in docking. One is called a ligand (here, it is a medicine), and the other one is receptor (or active site) of the target protein, such as Mpro, which can be used to dock. An effective drug docks with the active site, by covalent links, which makes the enzyme dysfunctional or destroys it.

A visualization of docking of a small ligand molecule (blue) with protein receptor (red).

To simulate the docking, researchers need to know the precise spatial structure of the drug molecule (they are available in special databases) and the precise configuration of the target proteins active site. Here, researchers may face the first challenges: there might be dozens or even hundreds of such sites, and they are not fixed in space. Thats why classical docking does not work in SARS-CoV-2.

To overcome this problem, chemists from HSE University and the Zelinsky Institute decided to use on-top docking, which they came up with shortly before the pandemic. They decided not to focus on the previously described active site, but to investigate the whole surface of Mproprotein with many medications, hoping that the big calculation powers would return useful dockings.

The researchers used the spatial model ofSARS-CoV-2 Mprocreated in January 2020 from PDB database (ID 6LU7). The potential drugs were taken from the database of medications approved by the United States Food and Drug Administration (FDA). The research teams own algorithms were used for modeling.

The modeling data demonstrated that sulfur-containing drugs show unusually high ligand efficiency at the active center of SARS-CoV-2 main protease Mpro, but only disulfiram 4 retains stable interactions.

Structure formula of disulfiram.

Today, it is most commonly used for treating alcoholism, since disulfiram inhibits the acetaldehyde dehydrogenase enzyme. As a result, the conversion of ethanol in the liver stops on the stage of acetaldehyde. Its concentration in the body grows, leading to acute intoxication, accompanied by sickness, vomiting and extreme pain. As a result, alcohol addicts acquire a conditioned reflex of disgust to the smell and taste of alcohol-containing drinks. This means that if the effectiveness of disulfiram against the novel coronavirus will be confirmed, this would help to solve two problems in Russia at once, at the same time decreasing alcohol addiction in the population.

Disulfiram fights SARS-CoV-2 in two ways. First, as previously demonstrated in vitro with SARS and MERS coronaviruses, it is a covalent inhibitor. In addition, it fights COVID-19 symptoms such as the significant decrease in reduced glutathione, which is an important antioxidant. This deficiency may lead to severe manifestations of the disease.

In addition to disulfiram, the Russian chemists were the first to predict the potential efficiency of neratinib, an irreversible tyrosine kinase inhibitor, against SARS-CoV-2. Just recently, in 2017, FDA approved neratinib as an adjuvant treatment of breast cancer.

Modeling has shown that both potential inhibitors of the main coronavirus protease (Mpro) are, presumably, covalent. For example, disulfiram can probably block the Mpro enzymatic activity by thioldisulfide exchange reaction, while neratinib binding suggests the possibility of covalent interaction similarly to covalent peptide inhibitors.

Its important to clarify that any modeling can only predict such interactions, but not prove their presence. The research cycle consists of at least three stages: modeling, synthesis of potentially active structures, and biological (pharmaceutical) testing of the necessary activity real, rather than calculated effectiveness of the drug. Modeling alone, just like any other theoretical research, means nothing without following experimental confirmations. Thats why now is time for extensive practical work on validating the results received as part of on-top docking.

The tests that were performed on July 27, 2020, at Reaction Biology Corp., a certified laboratory in the U.S., demonstrated that disulfiram really inhibits Mpro in 100 nm concentration, which confirmed the results of the modeling. Unfortunately, the second substance neratinib demonstrated activity on Mpro, but it was insufficient for clinical use. On September 1, 2020, clinicians will start drug trials in vitro and in experimental treatments of patients with SARS-Cov-2.

Chinese biochemists carried out a massive experimental search for active structures simultaneously and independently of the Russian researchers. They have also detected potential activity of disulfiram to the SARS-CoV-2 virus main protease Mpro. Unfortunately, they did it two weeks earlier than the Russian chemists, so the publication in Nature is theirs (the paper will be issued in August). This serves as additional evidence of the importance of having powerful computational resources for modelling and capabilities for biological experiments.

We need an opportunity to claim the results immediately in a high-level Russian chemistry journal. And there are only a few of them. Unfortunately, if we approve only publications in 1st and 2nd quartile journals, which are exceptionally international, such Russian journals will never appear. Igor Svitanko, Doctor of Sciences (Chemistry), Professor at the HSE Joint Department of Organic Chemistry with the RAS Zelinsky Institute of Organic Chemistry

Meanwhile, the main achievement is the demonstration that the on-top docking approach is working and returns quite realistic and controllable results. The teams plans for late 2020 and 2021 include molecular modeling of treatments for diseases that have demonstrated their harmfulness but have not yet spread over the world.

Its important to mention that any molecular modeling requires significant computational resources, and before cooperating with HSE University, the chemists had been able to use their method only on very limited terms. Today, they have access to HSE Universitys powerful supercomputer, which can help them search among existing drugs and perform targeted synthesis of new pharmaceutical products.

This is a brilliant example of fruitful cooperation between a university and a Russian Academy of Sciences institute. An obvious next step in such academic cooperation is organizing a Laboratory of Molecular Modelling at HSE University. This laboratory would not only create drugs, but it would model various chemical processes both by means of docking or other simple methods and by more universal and complicated quantum chemistry methods.

Meanwhile, the global chemistry community is facing the next challenge modeling the structure of an inhibitor for the protein of the G4 EA H1N1 virus a novel swine flu that was recently been detected in China. Researchers believe that this infection is much more dangerous and transfers more quickly from a human to human than COVID-19. To deal with it, researchers will need support, both in terms of resources and tools, and they will also need support organizing productive academic work and priority setting.

Reference: Computational identification of disulfiram and neratinib as putative SARS-CoV-2 main protease inhibitors by Victor S. Stroylova and Igor V.Svitanko, 4 August 2020, Mendeleev Communications.DOI: 10.1016/j.mencom.2020.07.004

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Medication Used for Alcoholism Treatment Is Potentially Effective Against COVID-19 - SciTechDaily

The world will be in order if good laws are established. Chinas first Civil Code was approved at the third session of the 13th National Peoples Congress and will come into force on January 1, 2021. As a fundamental body of law with a solid foundation, stable expectations and long-term benefits, its compilation is a significant milestone for the rule of law in China. The Civil Code consists of seven parts: general provisions, real property, contracts, personality rights, marriage and family, inheritance and tort liability and covers all aspects of individuals personal and property relationships. In this article, we aim to highlight the most significant parts of the Civil Code that directly relate to pharmaceuticals and healthcare by comparing those parts with legal provisions that were previously scattered through a variety of pharmaceuticals and healthcare legislation.

1. The Part on Personality Rights: Pharmaceutical and Healthcare Provisions

The independent compilation of personality rights is a pioneering initiative of the Civil Code. It embodies the concept of people-oriented and responds to the challenges of protecting personality rights in the information age. Personality rights[1] are primarily the rights of natural persons that are based on personal freedom and human dignity. However, personality rights are not unique to natural persons. Legal persons also have personality rights. According to the Civil Code, the main personality rights of natural persons and legal persons are as follows:

From this it is evident that the protection of natural persons personality rights, especially the protection of life, body, health, privacy and personal information, will be closely related to the field of pharmaceuticals and healthcare.

The provisions concerning clinical trials of drugs and medical devices in China are scattered throughout sector-based or departmental legislation. This legislation incudes, for example, the Good Clinical Practice for Medical Device Trials (effective as June 1, 2016), the Good Practice for Clinical Trials of Drugs (effective as July 1, 2020), and the Law on Promotion of Basic Medical Care and Health (effective as June 1, 2020). The revision of the Civil Code contains provisions dealing with clinical trials on human beings, which are based on the relevant sector-based legislation, and summarizes the basic principles concerning such trials. It also reflects the importance attached in China to the rights of all people to life, body and health, and helps to promote the norms for, and healthy development of, clinical trials in the new drugs and medical devices fields. To illustrate, the table below compares the relevant sector-based regulations with the applicable provisions of the Civil Code.

Before the Civil Code was promulgated, the Regulations on Human Organs Transplantation (effective as of May 1, 2007), and the Regulations on Acquisition and Distribution of Human Donated Organs (effective as of March 1, 2019) regulated human organs donations and transplantations, but did not cover human cells or human tissues.

On July 10, 2008, the PRC Ministry of Health (this Ministry was dissolved in March 2013) issued the WHO Guidelines for Human Cell, Tissue and Organ Transplantation (Draft) (the draft was revised by the 62nd World Health Assembly on March 26, 2009 and reviewed and approved by the 63rd World Health Assembly on May 21, 2010). These Guidelines are used by hospitals in China that are qualified to perform human organs transplantations for reference in clinical practice. However, domestic legislation in China has not officially incorporated the WHO Guidelines for Human Cell, Tissue and Organ Transplantation.

The Regulations on Administration of Human Genetic Resources (effective as of July 1, 2017) prohibit the trading of organs, tissues and cells containing human genome, genes or any other genetic materials. However, there are no provisions regarding the donation of such organs, tissues or cells.

Hence, the compilation of the Civil Code not only establishes the basic principles underpinning the altruistic donation of human cells, tissues, organs and corpses, but also expressly prohibits the trading of human cells, tissues, organs and corpses in any form. This is one of the highlights of the revisions. It is expected that, after the promulgation of the Civil Code, rules governing the donation of human cells and tissues other than human organs may also be implemented and refined through sector-based or departmental legislation. The table below compares the relevant provisions contained in sector-based legislation and the relevant articles of the Civil Code.

Article 1009 of the Civil Code provides that persons engaged in medical and scientific research activities related to human genes, human embryos, etc. shall abide by laws, administrative regulations and relevant provisions of the State, and shall not endanger human health, violate ethics and morals or undermine public interests.

The Civil Code specifically provides for the legality and compliance of medical and scientific research activities in the field of human genes and human embryos, and emphasizes that such activities shall not contravene ethics or damage public interests. These provisions in the Civil Code appear to be a legislative response to He Jiankuis case[2] on gene-edited babies in 2018. Applying gene editing technology to human embryos is not only a fundamental breach of ethics, but also a violation of laws and regulations. In addition to the Civil Code, the Technical Specifications for Human Assisted Reproduction effective as of October 1, 2003 also expressly state that genetic manipulation of human gametes, zygotes and embryos for the purpose of reproduction is prohibited.

Furthermore, the Regulations on Administration of Human Genetic Resources, which came into force just one year ago (July 1, 2019), also contain detailed provisions on the collection, preservation and use of genetic materials containing human genes and other genetic materials. In this way, Chinas codified Civil Code keeps pace with the times, incorporates the latest legislative developments, and reflects the public interest and welfare needs.

The protection of privacy and personal information in the Civil Code is provided for in Chapter Six (Right of Privacy and Personal Information Protection) of Part Four (Personality Rights). This is also an important part of the Civil Code.

Privacy refers to a natural persons peaceful private life and his/her private space, private activities and private information that he/she does not wish to be known to others. Personal Information refers to various types of information recorded electronically or otherwise that can identify a specific natural person either alone or in combination with other information, including the natural persons name, date of birth, identity document number, biometric information, residential address, phone number, e-mail address, health information, location information, etc.

As one type of personal information, health information such as personal medical records and diagnostic data is usually private and not wishing to be known to others. With respect to personal information of a private nature, according to Paragraph 3 of Article 1034 of the Civil Code, personal information of a private nature shall be governed by the provisions on the right of privacy, and in the absence of applicable provisions thereof, by the provisions on personal information protection.

Under the Provisions for the Administration of Medical Records of Medical Institutions (effective as of January 1, 2014) (the Provisions), China has established strict requirements for the preservation of medical records. Article 6 of the Provisions states that medical institutions and their medical staff shall strictly protect the privacy of patients, and are strictly prohibited from disclosing patients medical records for any purpose other than medical treatment, teaching or research.

In addition, Article 1226 of Chapter VI (Medical Damage Liability) of Part Seven (Tort Liability) of the Civil Code provides that medical institutions and their medical personnel shall keep confidential the privacy and personal data of their patients, and that they shall bear tort liability if divulging their patients privacy and personal data or medical records without the patients consent.

2. The Part on Contracts: Improve Electronic Contract Rules, and Support the Standardized Development of the Internet, and Pharmaceuticals and Healthcare

Electronic contracts play an increasingly important role in the development of the market economy in China. This is also the case in the pharmaceuticals and healthcare industry. Paragraph 3 of Article 5 of the Guiding Opinions on Improving the Centralized Drug Procurement for Public Hospitals (Guo Ban Fa [2015] No. 7) specifies that, where conditions permit, eligible places are encouraged to conduct electronic transactions and to adopt various methods, such as signing electronic contracts and using online payments through a centralized drug procurement platform to save transaction costs and improve the transparency of transactions. Furthermore, it is inevitable that electronic contracts will be more widely used in Internet diagnosis and treatment, remote consultation, online sales of drugs and medical devices and other related activities. The Civil Code reflects the needs of the market and of the times, and includes pioneering provisions concerning the signing and performing electronic contracts.

The Civil Code confirms in Chapter II (Conclusion of Contract) of Part III (Contract) that an electronic contract is a written contract (Article 469[3]). The rules governing the date[4] (Article 491) and place (Article 492[5]) of the conclusion of the electronic contract are set forth in the general provisions, as shown in the table below. These rules may be excluded by agreement of the parties.

Chapter IV (Performance of the Contract) in Part III (Contract) sets forth general provisions concerning the delivery time of the subject matter of an electronic contract (Article 512[6]), which depends on the subject matter and delivery method. Where the parties do not agree in the electronic contract on specific arrangements for delivery, the delivery time shall be determined in accordance with the rules in the table below. These rules may also be excluded by agreement of the parties.

Following the promulgation of the Measures for the Administration of Internet Drug Information Services (on November 17, 2017), the Measures for the Administration of Internet Diagnosis and Treatment (for Trial Implementation) (on July 17, 2018), the Specifications for the Administration of Remote Medical Services (for Trial Implementation) (on July 17, 2018), and the relevant provisions on building an integrated online and offline medical service mode in the Law on Promotion of Basic Medical and Health (on June 1, 2020), the concept of Internet plus Pharmaceuticals and Healthcare has become something of a trend.

According to the Opinions on Promoting the Development of Internet Plus Pharmaceuticals and Healthcare issued by the General Office of the State Council on April 25, 2018, the Internet Plus Pharmaceuticals and Healthcare service system includes Internet Plus Public Health Services, Internet Plus Family Doctor Contractual Services, Internet Plus Medicine Supply Guarantee Services and Internet Plus Medical Insurance Settlement Services. The implementation of detailed rules in the Civil Code for the signing and performance of electronic contracts is without doubt beneficial to the healthy development of Chinas Internet-based healthcare industry. Specifically, when conducting online drugs sales, Internet diagnosis and treatment, remote consultation or other electronic transactions, if the parties concerned have no clear agreement on the date and place of formation of the contract and the delivery time of the subject matter, the relevant provisions of the Civil Code may be directly applied. This will help avoid unnecessary disputes and will facilitate consistent and healthy development of Internet Plus Pharmaceutical and Healthcare.

3. The Part on Tort Liability: Changes to Liability for Medical Malpractice

Chapter VI (Medical Malpractice Liability) of Part VII (Tort Liability) of the Civil Code provides for liability for medical malpractice. This chapter consists of eleven articles and has been revised for consistency with the Tort Liability Law. Below, based on a comparison of the Civil Code and the Tort Liability Law (effective as of July 1, 2010), we highlight the three main amendments to Chapter VI.

As indicated in the Civil Code, the method required for medical personnel to notify a patient of information concerning diagnosis and treatment is elevated from written consent to express consent. Formally, this expands the method by which medical personnel perform the obligation of notification. That is, it is not limited to a written form. However, the requirement for notification by medical personnel is elevated from explain to explain in detail. In essence, this enhances the standard and requirement of explanation, which is helpful to put the notification obligation of the medical personnel into effect and not become a mere formality.

First, the Civil Code limits the application of the presumption of fault by medical institutions to diagnosis and treatment activities only and defines in greater detail the scope of tort liability.

Second, the Civil Code includes the loss of medical records as a circumstance resulting in the presumption of fault, and increases the responsibility for medical record management by medical institutions. It also revises the destruction of medical records to illegal destruction of medical records, reflecting obligations contained in the Provisions on the Administration of Medical Records of Medical Institutions. The Provisions on the Administration of Medical Records of Medical Institutions state that the minimum preservation time for medical records will depend on whether the records concern outpatient (emergency) treatment or hospitalization[7]. In any event, the preservation time for medical records is not indefinite. Consequently, the presumption of tort liability of medical institutions does not apply to lawful putting in order and destruction of medical records.

First, the Civil Code now includes the marketing authorization holder as a party bearing de facto joint and several liability for medical products, reflecting similar provisions in the Drug Administration Law (which came into effect on December 1, 2019). The Drug Administration Law added a new chapter containing a system to manage market authorization holders. It also provides in Article 6 of the General Provisions for the State to implement a drug marketing authorization holder system for drug administration, with the marketing authorization holder being responsible for the safety, effectiveness and quality controllability of the drug during the whole process of drug research, production, distribution and use according to law. As a result, the provisions of the Civil Code are consistent with industry legislation, paving the way for the convergence and streamlined application of different laws and regulations.

Second, the Civil Code changes the scope of medical products to which de facto joint and several liability can attach, from medical disinfectants to disinfection products, which is consistent with the Measures for the Administration of Disinfection (which took effect on December 26, 2017). Article 45 of the Measures for the Administration of Disinfection contains a specific definition of disinfection products which includes disinfectants, disinfection apparatus (including biological indicators, chemical indicators and sterilized goods packaging), sanitary supplies and disposable medical supplies. As a result, this codification of the Civil Code reflects changes in industry legislation.

Summary

The Civil Code is an encyclopedia for social life and a manifesto of civil rights, which has constructed a comprehensive system for civil rights protection. Not only is it important for the national economy and individuals livelihood, the Civil Code also introduces basic provisions on many subjects in the field of pharmaceuticals and healthcare, such as protecting the right of informed consent of patients, strengthening the protection of patients privacy and personal information, establishing basic rules for donation of human organs and human tissues and specifying the scope of application for medical malpractice liability. Law is the most important instrument for governing a country. A code that evolves with the times is beneficial not only to the protection of individuals well-being but also to their fundamental interests.

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Pharmaceuticals and Healthcare in the Civil Code - Lexology

Unbothered after a few hours of sleep? Studies suggest that not everyone may need seven or eight hours as generally recommended.

Adults aged between 18 and 60 should aim for seven or more hours of sleepper night, according to recommendations from the Centers for Disease Control and Prevention (CDC).

Not getting enough sleep is linked with many chronic diseases and conditionssuch as type 2 diabetes, heart disease, obesity, and depressionthat threaten our nations health,"the CDC says."Not getting enough sleep can lead to motor vehicle crashes and mistakes at work, which cause a lot of injury and disability each year.

RELOCATING DURING THE PANDEMIC? BEWARE OF MOLD, EXPERTS WARN

However, a new report out of Time magazine highlighted work byneurology professors at the University of California, San Francisco (UCSF) on sleep genetics and varying circadian rhythms, or the bodys complex clock system" from person to person.

Peoples internal clocks could be off by hours from one another, perhaps explaining why some are early to rise, while others prefer to stay up late.

The UCSF professors -- married couple Dr. Louis Ptacek and Ying-Hui Fu --are pioneers in sleep genetics. About 10years ago, Fu and her research teamfound a rare genetic mutationlinked to naturalshort sleep -- or those who equally benefit from just four to sixhours ofsleep compared to others who get eight hours of shut-eye, according to the report.

Not everyone may need seven to eight hours as generally recommended, studies suggest. (iStock)

Last year, the scientists found another mutatedgene, and according to Time, Ptacek and Fu are set to submit an upcoming paper on another gene, building evidence that faring well on short sleep is a genetic trait.

If we can get a better understanding of why their sleep is more efficient, we can then come back and help everybody sleep more efficiently, Fu told the magazine.

MAN WITH CORONAVIRUS WAKES FROM HIS COMA TO LEARN COVID-19 KILLED HIS FAMILY

One research participant, Seemay Chou, also an employee at UCSF, and her mother underwent interviews and gave blood samples; both are short sleepers.Fu found that short sleepers are usually more energetic, optimistic, have higher pain tolerance, and increased longevity.

While there is still much to explore about sleep, Steven Lockley, associate professor of medicine at Harvard Medical School, says a person's internal clock is key to personalized medicine. In other words, the timing of certain medicines or tests could lead to more accurate or potent results, according to the report.

The report also referenced a small study out of Sweden, which found that men who exercised at 8 a.m. had higher levels of blood sugar than men who worked out at 4 p.m., hinting that exercise may have heightened benefits at certain times during the day.

Hopefully in the next five to 10 years, youd go to the doctor, give a breath test or a pee sample, and the doctor would know your biological time, Lockley told Time. Then all your test results and treatments could be based on your real internal time, which is going to be very different between you and me based on our internal clocks.

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Why some people may not need 8 hours of sleep, according to a new report - Fox News

A test that detects changing levels of tumour fragments in the blood may be an easy, non-invasive and quick way to predict who will benefit from immunotherapy, University of Toronto researchers say.

Immunotherapy canshrink tumours and prolong survival for patients for whom other treatments have failed. But it only helps about 20 to 30 per cent of patients and so far, clinicians have been unable to predict who will benefit.

Since immunotherapy can have severe side effects in a small percentage of patients, knowing whether to begin or continue would be helpful for patients weighing different treatment options.

A team of scientists and clinicians addressed this question with a novel study evaluating various cancer patients response to a specific immunotherapy drug usinga customized test based on each patients tumour profile.

They found that individual response to treatment can be predicted within weeks, based on increasing or decreasing levels of DNA fragments which are shed from the tumour into the blood.

Genomic testing with powerful new technologies can detect the same genetic mutations in the fragments circulating in the blood as in the actual tumour. These fragments are called circulating DNA or ctDNA.

Specifically, the study found that a decrease in these circulating tumour DNA fragments at six toseven weeks after treatment with the immunotherapy drug pembrolizumab was associated with a beneficial response to the drug and longer survival.

The study, Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab, was published in Nature Cancer this week.

Dr. Lillian Siu, a professor in the department of medicine at U of T's Faculty of Medicine, senior scientist and medical oncologist at Princess Margaret Cancer Centre and BMO Chair in Precision Cancer Genomics, noted that the study is one of the first studies across a broad spectrum of tumours to show that measuring levels of ctDNA could be useful as a predictor of who responds well to immunotherapy.

Its like a molecular CT scan that gives us a molecular dimension, an added layer of information to know whether a tumour is growing or not, saidSiu, a co-senior author of the paper. Thats why this is so exciting. It helps to predict early on what may happen over time. Although important, computerized tomography (CT) and other scans alone will not tell us what we need to know quickly or accurately enough.

Dr. Scott Bratman, an associate professor of radiation oncology and medical biophysics and first author on the paper, saidit may take many months to detect whether a tumour is shrinking with various imaging scans.

New next-generation sequencing technologies can detect and measure these tiny bits of cellular debris floating in the blood stream accurately and sensitively, allowing us to pinpoint quite quickly whether the cancer is active, said Bratman, a radiation oncologist and senior scientist at Princess Margaret.

The prospective study analyzed the change in ctDNA from 74 patients, with different types of advanced cancers, being treated with pembrolizumab.

To customize or personalize the test, all the genes from the tumour biopsy tissue of each patient were sequenced or decoded, with specific attention to the mutations that occur in cancer.These mutations ranged from dozens to tens of thousands of mutations per tissue sample, differing according to cancer type.

Sixteen genetic mutations for each patient were then selected for a specific test to be developed and customized to detect personalized ctDNA of each patient via a simple blood sample.

When we looked at all 20,000 genes in each cancer, the range of mutations in different individuals was huge due to the many different cancer types in the study, saidDr. Trevor Pugh. Aco-senior author on the paper and an associate professor in the department of medical biophysics, he is alsoa senior scientist at Princess Margaret and director of genomics at the Ontario Institute for Cancer Research.

The novelty is that, rather than taking a one-size-fits-all approach, we designed a personalized blood test for each person based on their own cancers mutation list, Pugh said.

Of the 74 patients, 33 had a decrease in ctDNA levels from their original baseline levels to week six to seven after treatment with the drug. These patients had better treatment responses and longer survival. Even more striking was that all 12 patients who had clearance of the ctDNA to undetectable levels during treatment were still alive at a median follow-up of 25 months.

Conversely, a rise in ctDNA levels was linked to a rapid disease progression in most patients, and poor survival.

Few studies have used a clinical biomarker across different types of cancers, saidSiu, who is also the clinical lead for the Tumor Immunotherapy Program at the Princess Margaret, adding that the observation that ctDNA clearance during treatment and its link to long-term survival is novel and provocative, suggesting that this biological marker can have broad clinical impact.

This research was funded by the Princess Margaret Cancer Foundation, Ontario Institute for Cancer Research, Terry Fox Research Institute, Gattuso-Slaight Personalized Cancer Fund, BMO Chair in Precision Cancer Genomics, Canada Research Chair in Translational Genomics, Canada Foundation for Innovation, Ontario Ministry of Research and Innovation, and Merck for the study drug.

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Blood test could predict who will benefit from immunotherapy, researchers find - News@UofT

Cambridge Aug 7, 2020 (Thomson StreetEvents) -- Edited Transcript of Alnylam Pharmaceuticals Inc earnings conference call or presentation Thursday, August 6, 2020 at 12:30:00pm GMT

* Akshay K. Vaishnaw

Alnylam Pharmaceuticals, Inc. - President of Research & Development

Alnylam Pharmaceuticals, Inc. - Senior VP & Head of U.S.

* Barry E. Greene

Alnylam Pharmaceuticals, Inc. - President

Alnylam Pharmaceuticals, Inc. - Senior VP of IR & Corporate Communications

* Jeffrey V. Poulton

Alnylam Pharmaceuticals, Inc. - Executive VP, CFO and Principal Financial & Accounting Officer

* John M. Maraganore

Alnylam Pharmaceuticals, Inc. - CEO & Executive Director

* Yvonne L. Greenstreet

Alnylam Pharmaceuticals, Inc. - COO

SVB Leerink LLC, Research Division - MD of Genetic Medicines & Senior Research Analyst

Stifel, Nicolaus & Company, Incorporated, Research Division - Co-Head of the Biotech Team, MD & Senior Analyst

UBS Investment Bank, Research Division - Associate Director and Research & Analysis Associate

Sanford C. Bernstein & Co., LLC., Research Division - VP

Ladies and gentlemen, thank you for standing by. Welcome to the Alnylam Pharmaceuticals Conference Call Second Quarter 2020. (Operator Instructions) Please be advised that this call is being taped at the company's request.

I would now like to turn the call over to the company. Please go ahead.

Christine Regan Lindenboom, Alnylam Pharmaceuticals, Inc. - Senior VP of IR & Corporate Communications [2]

Good morning. I'm Christine Lindenboom, Senior Vice President of Investor Relations and Corporate Communications at Alnylam. With me today on the phone are John Maraganore, Chief Executive Officer; Barry Greene, President; Akshay Vaishnaw, President of R&D; Jeff Poulton, Chief Financial Officer; and Yvonne Greenstreet, Chief Operating Officer. Andy Orth, Head of the U.S. Business, is also on the phone and available for Q&A. For those of you participating via conference call, the accompanying slides can be accessed by going to the Events section of the Investors page of our website, investors.alnylam.com/events.

During today's call as outlined in Slide 2, John will provide some introductory remarks and general context, Barry will provide an update on our commercial and medical affairs progress, Akshay will review recent clinical and preclinical updates, Jeff will review our financials and Yvonne will provide a brief summary of upcoming milestones before opening the call for your questions.

I would like to remind you that this call will contain remarks concerning Alnylam's future expectations, plans and prospects, which constitute forward-looking statements for the purpose of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our most recent quarterly report on file with the SEC. In addition, any forward-looking statements represent our view only as of the date of this recording. It should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements.

With that, I'd like to turn the call over to John.

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John M. Maraganore, Alnylam Pharmaceuticals, Inc. - CEO & Executive Director [3]

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Thanks, Christine, and thank you, everyone, for joining the call today. Let me start by expressing Alnylam's support for Black Lives Matter and our support for the efforts to end systemic racism in our country. At Alnylam, we stand against all forms of discrimination; and in our core, we believe, in justice, equity and inclusion. We stand in support of peaceful protest aimed at achieving real and sustainable change. Enough is enough, and it's time to finally cure the refractory scourge of hate.

I'd also like to comment briefly on the Trump administration's recent announcement on drug prices. While we fully support the need to reduce or even eliminate patient out-of-pocket costs for prescription drugs, the administration's proposal to potentially introduce a so-called Most Favored Nation executive order is both unfortunate and misguided. Importing foreign price controls will harm American innovation and hurt our patients. Even if this executive order is finalized, we don't believe it will stand.

With that, let's now turn to our business. As all of you know, the COVID-19 pandemic remains dynamic, uncertain and unpredictable. That said, we continue to view the situation in the same framework we discussed last quarter: a pandemic phase in Q2, a recovery phase in Q3 and a new normal starting in Q4. While the pandemic continues or even worsens in many states in the U.S., we believe Alnylam's business is benefiting from our broad global presence. In spite of the ebbs and flows, we are seeing health care systems now remaining open, and we don't currently expect a repeat shutdown of health care systems like what was seen in Q2, especially in the April-May time frame.

Our confidence in the second half is reflected in an upward revision in our ONPATTRO revenue guidance range. Overall, we're really proud of our field teams around the world and their ability to adapt quickly and safely to meet the needs of patients, embodying our challenge accepted mentality.

We are extremely pleased with global ONPATTRO and GIVLAARI top line performance in Q2, which Barry will elaborate on shortly. We're also proud of the significant progress we made across our pipeline in the quarter, as Akshay will discuss. Another highlight for the quarter was our landmark strategic financing collaboration and inclisiran royalty monetization we completed with Blackstone Life Sciences worth up to $2 billion. We believe this collaboration secures our bridge toward a self-sustainable financial profile without the need for any future equity financings.

Now before I share my -- before I close -- before I share my closing remarks, I want to take a moment to acknowledge the news we announced earlier this morning about Barry Greene's planned departure from Alnylam at the end of the quarter. Barry and I have been working side by side for over 20 years, first at Millennium and then for 17 years at Alnylam. And I know that I speak for everyone at Alnylam in thanking Barry for his exceptional contributions and dedication to the company. We all owe him tremendous gratitude for his outstanding leadership and track record that have contributed to the delivery of RNAi therapeutics as a whole new class of medicines for patients. I have no doubt Barry will continue to be a highly impactful leader in the life sciences. I'm grateful for his agreement to consult with Alnylam as needed for a 2-year period, and I wish him all the very best in his next endeavors.

We are also very pleased to share that Yvonne Greenstreet, our current Chief Operating Officer, will step into the expanded role of President and Chief Operating Officer on October 1. We believe Yvonne is uniquely suited for this opportunity given her strong command of our business, strategic leadership and proven ability to drive results.

We are initiating a search for a Chief Commercial Officer. And during the search, we anticipate no impact to our ongoing commercial execution. Please join me in wishing Barry well as he pursues the next chapter of a remarkable career and congratulating Yvonne on her expanded role at Alnylam.

I'd like to finish with my perspective on the big picture for the company. We continue to lead the advancement of RNAi therapeutics as a whole new class of medicines, and we remain on track to achieve and exceed our Alnylam 2020 goals, exiting 2020 as a multiproduct global commercial company with a deep clinical pipeline for future growth and a robust and organic product engine for sustainable innovation. Without a doubt, we're excited for the promising future that Alnylam is poised to deliver as a top-tier biopharmaceutical company focused on advancing medicines with transformative potential for patients around the world.

With that, I will now turn the call over to Barry -- for one last time, Barry, to review our commercial progress and medical affairs activities in more detail. Barry, take it away.

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Barry E. Greene, Alnylam Pharmaceuticals, Inc. - President [4]

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Thanks, John, and good morning, everyone. Before I provide the quarterly highlights, I'd like to make some brief remarks about my planned transition from Alnylam. First, congratulations again to Yvonne Greenstreet. She is a remarkable person and well deserves the President and COO role. I know that Yvonne will make sure that Alnylam continues to be a company doing the right things and focusing on patients, and I'm counting on it.

As for me, it's been a tremendous privilege to serve as President of Alnylam for such a long period of time. I'm very proud of what we've been able to accomplish during my 17 years, and we built a global fully integrated multiproduct company that is recognized for excellence in R&D and recently for our commercial strength as well. My decision to transition is based on the desire to pursue new leadership opportunity in the next chapter of my career. I'm fully confident Alnylam will achieve its ambitious goals with quality and excellence with the great team we have in place. I'll continue to support Alnylam throughout this transition and have no doubt about the company's future prospects as a top-tier biopharmaceutical company.

So let's now review our (inaudible). For ONPATTRO, we achieved $66.5 million in global net product revenues. As of June 30, over 1,050 patients were on commercial ONPATTRO treatment worldwide, representing an increase of over 100 patients from end of Q1, a very impressive accomplishment in the height of the global pandemic during Q2.

Let's start with some more color on the U.S. As anticipated, the COVID-19 pandemic had impact on our business in the second quarter, with patient demand decreasing due to reduced adherence as some patients skip doses or experience dose delays while moving to new care sites. Also as anticipated, we saw the pace of new patient initiating therapy slow in the U.s. during the quarter due to reduced genetic testing, diagnosis and patient flow through the health care systems. Finally, our U.S. business was also impacted by inventory destocking and an increase in cost in the second quarter. Jeff will provide more color on these details later in the call.

While our focus today is on Q2, as we enter Q3, we're now seeing what looks like a healthy return of genetic testing and patient flow through the U.S. health care system even in states where COVID-19 cases are rising. And in fact, our July, on our last numbers are near the January numbers we saw earlier in the year. A really good sign.

In the second quarter, we continue to see great progress in new prescribers. For the second quarter, 40% of submitted start forms came from new writers with an equal mix of neurologists and cardiologists. In the U.S., we saw continued concomitant use of ONPATTRO with TTR stabilizers in the quarter. We believe this trend will continue to grow as physicians see progression of polyneuropathy on stabilizers and treat the different manifestations of hATTR amyloidosis.

Now turning to the rest of the world. We made very positive progress with ONPATTRO in the second quarter. Rest of world sales for ONPATTRO were [$34.2 million] and relative to the U.S. benefited from continued geographic expansions with launches in Spain, Italy and other countries. In addition, we saw relative strength in our ex U.S. markets between Europe and Japan for their management of the pandemic. As John noted, this is a nice validation of the decision to build a global, fully integrated business.

With today's announcement of achieving pricing and reimbursement agreement in France, we're pleased to report that access has been secured in all priority markets in Western Europe. Notably, our team has secured pricing and reimbursement approval in all major European markets in under 2 years post-approval by the EMA. This is a much faster rate than most orphan medicines are able to achieve.

Japan was again a country of strength for ONPATTRO. Japan has now become our second-largest country after the U.S. for our ONPATTRO revenue, and we expect continued growth in new patient (inaudible) discussion on stabilizer therapy.

On the medical care side, our team remains committed to addressing the challenge of raising disease awareness and improving diagnosis of hATTR amyloidosis, including with Alnylam Act, our third-party genetic screening initiative in the U.S., Canada and Brazil. As of July, over 27,000 samples have been submitted, out of which over 1,600 have tested positive for pathogenic TTR mutation, which is tracking at a historic 6% to 8% positivity rate. These numbers show the testing slowdown in Q2 we mentioned on our last earnings call. The good news is that (inaudible), those numbers have picked up to near January levels.

Moving on to GIVLAARI. We are really pleased with the progress in our launch, most of which was done virtually. We achieved $11 million in global net product revenues. We received over 85 start forms in the U.S. with over 100 patients globally on commercial treatment from launch through June 30. As we have now begun to open ex U.S. territories and also because currently 25% to 30% of U.S. patients come from outside the start form channel, we'll discontinue providing start form metrics in future quarters as we did last year for ONPATTRO.

In the U.S., we observed a broad prescriber mix, including hepatologists, gastroenterologists and other specialties, both in preferred centers of excellence and in the community. Of note, 76% of our Q2 starts were from new writers.

Our progress with value-based agreements has been extremely strong with 7 VBAs completed with U.S. payers, and we now have confirmed access for over 75% of covered U.S. lives across commercial, Medicaid and other government payers. We've not experienced any care (inaudible) to date, pleased to see plans adopt medical policies, not more restrictive than our labeled indication.

ASMR III saw strong initial performance as well with the successful and as noted virtual launch in Germany as well as named patient sales in other countries, including French cohort ATU program.

We've been positively encouraged by the responsiveness of European payers despite the COVID-19 pandemic. Of note, GIVLAARI received an improvement of medical benefit or ASMR score of 2 in France, concluding that GIVLAARI offers significant additional therapeutic value. This is an enormous accomplishment. For context, only 2 new commercial medicines were granted with an ASMR rating of 2 for 2019.

Our medical affairs team is also focused on improving awareness and diagnosis with AHP. Through Alnylam Act, we can report 937 test submitted and 92 patients with positive AHP mutations as of mid-July, showing continued 10% positivity rate. A notable diagnosis trend emerging is the robust use of urinary PPG test informed diagnosis, and we expect patient identification efforts will be meaningfully enhanced by this nongenetic testing method.

Of course, we're now also preparing for the potential launch of lumasiran later this year. Importantly, we'll be leveraging our existing commercial infrastructure for this launch with small additions of resources for field-based teams. When we gain approval, we'll let (inaudible) specific commercialization (inaudible) support medicine (inaudible) therapeutic expected to market.

In conclusion, the second quarter was challenging due to the pandemic particularly in the United States, but was much better than the downside case we anticipated as we entered Q2. The credit goes to our teams around the world who face the obstacles head on to deliver the important medicines to our patients.

With that, I'll now turn the call over to Akshay to review our recent R&D and pipeline progress. Akshay?

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Akshay K. Vaishnaw, Alnylam Pharmaceuticals, Inc. - President of Research & Development [5]

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Good morning, everyone, and thank you, Barry. I should say thank you, Barry, for guiding me, for helping build our company and, most of all, for working so tirelessly to help all the patients we seek to serve.

So with that, I'll start with our efforts in ATTR amyloidosis where we're advancing our 2 product candidates: patisiran and vutrisiran. As ONPATTRO is currently approved in multiple markets around the world to treat polyneuropathy associated with hATTR amyloidosis, we're committed to expanding the product's label to include the treatment of cardiomyopathy in both hereditary and wild-type ATTR amyloidosis patients. To this end, we continue to enroll patients in APOLLO-B and continue to expect completion of enrollment in 2021.

We've seen enrollment pick up over the last month as clinical sites start to open up around the world. In addition, we're also advancing vutrisiran, an investigational RNAi therapeutic delivered by quarterly subcutaneous injection that's also in development for the treatment of ATTR amyloidosis. Here, we're conducting 2 Phase III studies. The first is HELIOS-A, which is evaluating vutrisiran in hATTR amyloidosis patients with polyneuropathy. Enrollment is complete in HELIOS-A, and we remain on track to report top line results early next year. The second Phase III study of vutrisiran is HELIOS-B, which is being conducted in in inherited and wild-type ATTR amyloidosis patients with cardiomyopathy. As with APOLLO-B, site activation enrollment in HELIOS-B are now picking up. If HELIOS-B is positive, it could allow for vutrisiran's entry into the very large wild-type ATTR amyloidosis market opportunity with the product label that includes cardiovascular outcomes.

Let's move to GIVLAARI, which is approved in the U.S., EU and now in Brazil to treat acute hepatic porphyria in adults. Of course, the highlight of GIVLAARI in the recent period was our Brazilian approval, and we're continuing our geographic expansion for this product with MAA submitted in Switzerland and Israel and plans for submission in Japan in the coming months. During the second quarter, we also presented a new 12-month interim data from the ENVISION Phase III study, demonstrating sustained efficacy and acceptable safety through 12 months of treatment, with evidence for potentially improved efficacy over time. In addition, we're proud to have published pivotal results from the ENVISION Phase III study in The New England Journal of Medicine. This is our ninth paper on RNAi therapeutics published in the journal.

I'll now turn to recent progress with lumasiran, an investigational RNAi therapeutic that we're developing for the treatment of primary hyperoxaluria type 1, or PH1. At the ERA-EDTA meeting in June, we reported the full set of positive results from ILLUMINATE-A, which demonstrated that lumasiran significantly reduced urinary oxalate levels, the cause of progressive kidney failure in PH1. In addition, lumasiran showed an encouraging safety profile. Our overall lumasiran program also includes our ILLUMINATE-B study in pediatric patients under 6 years of age. Enrollment is complete, and we remain on track to report top line results soon in mid-2020. The ILLUMINATE-C study in severe PH1 continues to enroll and has been proceeding well even during the pandemic. We completed our NDA and MAA submissions in the second quarter. The FDA granted priority review for the NDA and has set an action date of December 3, 2020. EMA has granted accelerated assessment of the MAA.

As you know, we have 2 additional late-stage programs that are in development with partners. This includes inclisiran in the development -- in development for hypercholesterolemia partnered with Novartis, which is currently under review for approval in the U.S. and EU. Both NDA and MAA filings have been accepted, and Novartis expects initial approval in the U.S. in late 2020. Novartis has indicated that they remain on track for approval this year with a December action date in the U.S.

Our late-stage pipeline also includes fitusiran in development for hemophilia A or B with or without inhibitors, partnered with Sanofi. Sanofi has recently disclosed that 2 of the 3 ATLAS Phase III studies have completed enrollment and that they remain on track to report top line ATLAS Phase III data in the first half of 2021. Sanofi also presented new positive results from an interim analysis of the Phase II OLE study of fitusiran, showing impressive reductions in the annualized bleeding rate with encouraging safety.

Now in addition to our late-stage clinical programs, we believe we've also been making great progress with our early and mid-stage programs. The highlights of the quarter was the positive top line results from our ALN-AGT Phase I study in patients with hypertension, specifically ALN-AGT demonstrated an over 90% knockdown of angiotensinogen and a greater than 10 millimeters mercury lowering systolic blood pressure with the durability that's caused a quarterly or even less frequent subcutaneous dosing regimen. We're also encouraged by the tolerability profile for ALN-AGT. We now look forward to presenting more complete data from the ongoing Phase I study at a scientific meeting in the second half, assuming abstract acceptance. We're very excited about the potential for ALN-AGT to reimagine the treatment of hypertension with tonic-controlled blood pressure that we believe could result in important benefit for patients.

Our next clinical program is ALN-HSD, an investigational RNAi therapeutic for the treatment of NASH, for which we recently filed a CTA. This program is being advanced in collaboration with Regeneron. We're also making strong progress on our many RNAi therapeutic opportunities beyond the liver.

For our COVID-19 RNAi therapeutic collaboration with Vir, we selected a development candidate, ALN-COV or VIR-2703, with potent and highly cross-reactive activity towards SARS-CoV-2, the virus that causes COVID-19. We continue to expect an IND filing around year-end 2020.

We're also pleased to announce today that Regeneron has elected to opt-in to the ALN-APP program. We aim to get an IND filed for ALN-APP in mid-2021, and this is expected to be our first CNS program to enter clinical development.

And with that, let me now turn it over to Jeff to review our financial results. Jeff?

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Jeffrey V. Poulton, Alnylam Pharmaceuticals, Inc. - Executive VP, CFO and Principal Financial & Accounting Officer [6]

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Thanks, Akshay, and good morning, everyone. I'm pleased to be presenting Alnylam's Q2 2020 results. As Barry has already highlighted, it was a very strong quarter of commercial execution, with outstanding results for both ONPATTRO and GIVLAARI.

Turning to our results first for ONPATTRO, generated $66.5 million in global net ONPATTRO revenue for the quarter, which was impacted by the pandemic, particularly in the U.S., with global growth being flat versus the first quarter of 2020 and a 74% increase compared with Q2 2019. U.S. growth decreased 13% during the quarter compared with Q1 and was primarily impacted by the following: a 4% decrease in demand from reduced patient adherence due to the COVID-19 pandemic, as Barry previously mentioned; an 8% reduction due to inventory destocking during the quarter with pending inventory now at 1.5 weeks in the distribution channel at the end of Q2; and a 1% decrease due to a modest increase in gross to net deductions in the quarter. We continue to expect gross to net deductions will remain in the mid-20s globally for ONPATTRO in 2020.

In our international markets, performance was very strong in spite of the pandemic, with growth of 16% versus Q1. Growth in Europe was highlighted by strength in recently launched markets in Italy and Spain. While in Asia, growth in Japan remains robust, with Japan now representing our second-largest market for ONPATTRO based on dollar sales, as Barry mentioned. First time this quarter, the contribution of our international markets to global ONPATTRO sales exceeded the U.S. contribution. We are pleased to have a strong and global brand, which we believe is beneficial to long-term growth.

Turning to our results for GIVLAARI. We had a strong second quarter, generating $11 million in global net revenue in the quarter, representing over 100% growth compared to the first quarter. This growth was driven by ongoing success of the U.S. launch where we did not experience reductions in patient adherence at the same level as ONPATTRO as well as an additional contribution from our international markets with a successful launch in Germany and named patient sales in other countries, including France. Our combined product sales for ONPATTRO and GIVLAARI were $77.5 million for the quarter, representing 6% growth versus Q1, a strong result given the challenges associated with COVID-19 in the quarter.

Turning now to a summary of our full P&L results for the quarter. Net revenue from collaborations for the second quarter was $26.4 million, a significant increase from last year primarily due to revenue recognized from our Regeneron and Vir collaborations. Gross margin as a percentage of total revenue was 81% for the quarter, down from 90% in Q2 2019 primarily due to the current utilization of ONPATTRO full cost inventory. Last year benefited from 0 cost ONPATTRO inventory as well as having a higher proportion of sales in the second quarter of 2020 coming from lower-margin international markets and a write-off of ONPATTRO inventory at our contract manufacturer.

Our R&D expenses decreased on a non-GAAP basis in the second quarter of 2020 compared to the same period in the prior year primarily due to nonrecurring expenses in 2019 from license fees related to the execution of our collaboration agreement with Regeneron as well as a decrease in expenses associated with material manufactured for clinical trials. Conversely, SG&A expenses increased modestly on a non-GAAP basis in the second quarter of 2020 compared to the same period in the prior year primarily due to increased investment in commercial and medical affairs activity to support the ongoing launches of ONPATTRO and GIVLAARI and initial launch preparation activities for lumasiran.

Importantly, our non-GAAP operating loss for the second quarter decreased by approximately $40 million compared with the same period in 2019 driven by a combination of strong top line growth and very moderate growth in operating expenses. We remain confident that 2019 represents our peak non-GAAP operating loss year as we expect the trend of strong top line growth and moderate growth in operating expenses will continue for the balance of the year.

We ended the quarter with cash and investments of $1.95 billion, which includes $600 million in proceeds received in the second quarter from the partial sale of future inclisiran royalties and issuance of common stock to Blackstone.

Finally, turning to our financial guidance. We believe our results for the second quarter demonstrate the strength of our commercial teams in challenging circumstances. As a result of the strong commercial performance for ONPATTRO that exceeded our initial expectations back in the earlier phase of the pandemic in May, we are further revising our full year revenue guidance for ONPATTRO, with an increase in the midpoint of our guidance as we narrow the range from $270 million to $300 million to $280 million to $300 million. Guidance range for combined non-GAAP R&D and SG&A expenses as well as our guidance for net revenue from collaborations remain unchanged. Please note that we have revised the midpoint of our GAAP combined R&D and SG&A operating expense guidance downward by $25 million, reflecting a reduction in expected stock-based compensation during the year.

Regarding cash, we believe our strategic financing collaboration with Blackstone, adding up to $2 billion in cash, secures Alnylam's bridge towards a self-sustainable financial profile without the need for future equity financings.

And with that, I'll now turn the call over to Yvonne to review our goals for the remainder of the year. Yvonne?

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Yvonne L. Greenstreet, Alnylam Pharmaceuticals, Inc. - COO [7]

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Thanks, Jeff, and hello, everyone. Looking ahead to the second half of 2020, we have a number of important milestones lined up. Of course, we plan to continue our global commercialization of both ONPATTRO and GIVLAARI, and we're looking forward to our GIVLAARI launch in Brazil and an upcoming NDA filing for GIVLAARI in Japan. We're also expecting 2 additional regulatory approvals by the end of the year for lumasiran and inclisiran. We plan to continue enrollment in our ATTR cardiomyopathy studies, specifically APOLLO-B with patisiran and HELIOS-B with vutrisiran. With lumasiran, we're on track to share top line results of the ILLUMINATE-B Phase III study in mid-2020. And of course, we'll also continue advancing the rest of our pipeline as well as exciting preclinical efforts, and we'll highlight these milestones throughout the year as they occur. Among these will be our presentation of additional clinical results from the ongoing Phase I trial of ALN-AGT in hypertension program we're very excited about. We also plan to initiate a Phase I trial of ALN-HSD for NASH, having now filed the CTA for that program. And our partner, Regeneron, plans to initiate a Phase I study of cemdisiran in combination with pozelimab, having now filed the CTA for that study. We also hope that you'll join us for our remaining RNAi roundtables focused on lumasiran, givosiran and our TTR programs later in August and September.

Let me now turn it back to Christine to coordinate our Q&A session. Christine?

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Christine Regan Lindenboom, Alnylam Pharmaceuticals, Inc. - Senior VP of IR & Corporate Communications [8]

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Thank you, Yvonne. I just wanted to quickly acknowledge, we found issue with Barry's prepared remarks. There are some storms that are rolling through his area that impacted the audio quality, and we will plan to have Barry rerecord his remarks for the replay of this call.

So operator, let's now open the call for questions. (Operator Instructions)

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Questions and Answers

Excerpt from:

Edited Transcript of ALNY earnings conference call or presentation 6-Aug-20 12:30pm GMT - Yahoo Finance

U.S. President Donald Trump pumps his fists at supporters gathered to greet him on the airport tarmac during his arrival at Burke Lakefront Airport in Cleveland, Ohio, U.S., August 6, 2020.

Joshua Roberts | Reuters

President Donald Trump's upcoming fundraising swing through the Hamptons is set to raise $15 million for his campaign and the Republican National Committee.

The proceeds will be going to the Trump Victory Committee, a joint fundraising operation between Trump's campaign, the RNC and a variety of state parties. A committee official confirmed the total and noted that in the wake of the coronavirius pandemic, all attendees must follow local guidelines if they want to take part.

"For fundraisers with the President, the White House Medical Unit and U.S. Secret Service evaluate all attendees in order for them to gain access to the event," this official said. "All attendees must [test] negative for COVID-19 on the day of the event, complete a wellness questionnaire and pass a temperature screening."

The state of New York only allows social gatherings of up to 50 people, whileGov. Andrew Cuomo has continued to call on people across the state to stay socially distant and wear masks.The Hamptons is a region of New York and home to some of the wealthiest business executives in the country.

The president plans to befeaturedatthetwo in-person gatherings on Saturday, including one that will be at the Hamptons home of his son, Donald Trump Jr., and his girlfriend, Kimberly Guilfoyle, who also is a top fundraiser for Trump Victory, according to people with direct knowledge of the matter who declined to be named as the locations are deemed private Trump Jr. reportedly bought the property in Bridgehampton, N.Y. for $4.4 million.

Guilfoyle and Trump Jr., were also set to take part in a separate Trump Victory fundraising event on Thursday in the Hamptons, according to an invite reviewed by CNBC.

For Trump's Saturday afternoon event, tickets start at $50,000 for guests take part in a photo op and watch the president's remark. A ticket for $100,000 gets an attendee a seat at a roundtable discussion with the president. The later event on Saturday will cost up to $500,000 per couple to gain entrance.

The development of the massive fundraising swing comes after Trump's campaign announced that it, combined with the RNC, outraised their opponents in July. Trump and the RNC brought in $165 million last month while Joe Biden, the presumptive Democratic nominee, and the Democratic National Committee, raised $140 million. Trump and his team went into August with a slight cash-on-hand advantage over Biden of $300 million.

Trump Victory officials said their recent fundraising success represents the enthusiastic support for the president.

"I have been traveling around the country with President Trump over the last few weeks, and the level of enthusiasm is even higher than what I saw in 2016," RNC Chairwoman Ronna McDaniel told CNBC in a statement. "Everyone is excited to contribute, and those resources are fueling our data-driven ground game and critical legal efforts to protect election integrity."

"As Joe Biden remains locked up in his basement, President Donald J. Trump continues to receive unprecedented support across America," Guilfoyle added. "We outraised Joe Biden last month, and we will do it again. Don Jr. and I are thrilled to be hosting President Trump in New York this week."

Public polling shows Biden ahead of Trump by just more than 6 points, according to a Real Clear Politics polling average.

See original here:

Trump and RNC expected to raise $15 million in Hamptons fundraising swing - CNBC