Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
MRC--look what they tweeted out the morning the decision came out. Very eerie.
What did they know that others did not that led them to be so confident in how this would play out. Pure coincidence or something else?
March 30th
"You may only have between now and midday EST (morning in NV) today to sell or hedge $AMRN long positions. The court’s Findings of Fact is most likely to come today or tomorrow. Odds remain >85% Amarin will lose."
This organization was relentless from last year. What actions if any did they take here. One can only wonder.
Yes. Pauline Newman. We need her to be one of the judges. As mentioned, though, she is up there in age. 92
Regarding MRC. It is interesting that they nailed it on obviousness. Wonder if they sent their analysis to the judge.
https://www.scribd.com/document/451536443/Executive-Summary-of-MRC-s-Analysis-on-Amarin-v-DRL-Hikma
These patent trials can go either way depending on which judge you get. It is sad but true. Hope AMRN management realizes this now.
I believe there will be an oral argument for this case. Just my own opinion. The order for expedited appeal said oral argument will be scheduled once...
"The appeal will be placed on the next available oral
argument calendar once briefing is complete."
Correct. You are praying for the right judges.
If you get the wrong panel of judges (meaning they are not pro-patent), game over. Parsing the briefs is a great intellectual exercise, but it will not carry the day. Anyone who things otherwise you better be mindful of the panel of judges. Hopefully Amarin's executive team (JT and others) realize this. And this is something you can't control.
It is a sad indictment of the legal system but this is the reality. In an ideal world the factual and legal errors should carry the day but that is not the case in the real world.
It is all about getting the right judges. It looks like Amarin is going all the way with the appeal. Let's pray for Judge Newman.
It is truly a roll of the dice. And we won't know until the oral arguments occur. It is sad we are in this predicament but it is what it is at this point. Have to deal with reality.
Who made the decision to choose Nevada? The 9th circuit for crying out loud. Last I checked we had an office in NJ. Delaware, NJ...would have been better. Or a conservative state like Texas.
We have a tenacious foe on our hands. The generics have gone from being a nuisance to a major distraction and now they are trying to take a lot of the franchise value. This is a major fight. When you are in a battle you have to try to do everything possible to gain an edge. Nevada did not help us. That was someone's decision.
At any rate, this will be about the judges. It is a roll of the dice and we are in for a fight. We only have 2 amicus briefs so far. Not sure what AMRN is working on behind the scenes but I hope it is something. Otherwise you are praying for the right judges and his/her leanings going your way.
It is going to come down to the judges. I agree with you here. Does JT realize this? Is he going to roll the dice again?
What is his ultimate play here....
Correct. Nevada / 9th Circuit was the wrong venue. If it is true that a lawyer at Covington used to clerk for that court in Reno then perhaps AMRN thought it had an in. Clearly that was not the case.
At any rate, you don't have to be a rocket scientist to realize 9th Circuit is a liberal jurisdiction.
When I told my friend who is a patent attorney about the case, the first thing he said is why did they choose Nevada. SMH
Someone messed up big time in choosing Nevada.
Eastern District of Texas or even AMRN's backyard in NJ would have been better.
In terms of how readily known: only the judges and their clerks will know.
The parties will not know till day of oral argument. Unless trading is halted that day, I imagine the stock price will react depending on which judges are presiding and the questions being asked.
My friend said you should be able to get a feel for the leanings of the judges based on the questions asked.
He said pray you get Judge Newman.
I asked him that question: is it possible for the parties or others to find out in advance who the judges would be?
He said NO unless someone is committing an unscrupulous act.
So seems like we have to wait till day of oral argument where Amarin, the generics, and all of us will find out who the judges are.
I know...it's a mess but these are the cards we are dealt right now.
Singer--I heard back from my friend who just reviewed Singer's brief. My friend is a patent attorney and works for a Fortune 500 company. He knows Singer and has hired him before. My friend basically said the brief was a masterpiece and is a credit to how great of a patent attorney Singer is.
That being said, my friend said it will still come down to the judges you get. He said it is likely we could get Newman because some judges on the Federal Circuit don't want to be bothered with patent cases.
Of course we will not know which judges until the day of the oral arguments. My friend said Singer is so skilled though he will have different ways to frame his arguments depending on which judges are hearing the case. Singer will be ready rest assured.
Still, though, it will be about the judges. My friend laughed and said sometimes you hear about something being bet the company litigation and it is not, but this is truly a bet the company litigation situation.
Just wanted to convey what I learned.
Perceptive Advisors sold 100% of its position in AMRN.
I guess that's why Edelman is deemed to have a 6th sense for biotech.
He knew. lol
https://whalewisdom.com/stock/amrn
USPTO Amicus Briefs....see the link below
https://foiadocuments.uspto.gov/amicus/
Ideally it would be great if the FDA submitted an amicus brief but they would likely remain agnostic. The FDA submission of a brief (wishful thinking) would be huge. There is a public health implication here if AMRN decides not to advertise / educate the marketplace but FDA may choose to remain on sidelines. Perhaps the USPTO will submit a brief.
This litigation overhang on the stock price is real. SMH
Correct. Judges are humans and have bias and leanings.
Singer knows this and this is why I am curious as to Amarin's path going forward. Will our "conservative" CEO risk everything on the appeal and wait to see who the 3 judges are the day of oral argument, or does Thero have another play here aside from just banking everything on the appeal.
If they plan to see the appeal through, I'm sure they have a board with the judges marked out as to likelihood of success depending on which judge appears.
All about the judges.
It is not about politics per se but the judges' leanings / bias. Some judges are pro patent others are not.
My friend is a patent attorney. He knows Singer and says Singer is highly regarded. The one thing he made clear to me is this will come down to the judges. It is great we have Singer on our side but the Judges presiding over this case will be what is most important.
Fall in love with the briefs if you want too. My eye will be on the judges.
And while all this is great--it will still come down to the Judges.
These legal cases are not won on the briefs.
It is about the judges.
Let's pray we get pro patent judges.
By when do you see this playing out? The litigation process is getting ready to commence shortly with the filing of the Amarin's brief.
Do you think BO before oral argument, or after oral arguments (Amarin sees who the judges are)?
Thanks
Interesting, thanks!
Not I. Won't be going into the litigation un-hedged. That is just stupid.
Litigation is way too risky (praying you get the right judges). See district court case. If our conservative CEO wants to take that gamble again, I will be prepared. Who knows what our lawyers are telling him. Although I hope the answer is not akin to Buffett's quip about asking a barber if you need a haircut...
I told my friend who is a patent attorney about what transpired and he commented oh the CEO is a risk taker (given lack of settlement before district court case).
How do you explain the major shareholders (BB, Artisan Partners, Perceptive Advisors) tolerating this?
This is a head-scratcher. The loss of the district court case was a colossal let down.
Perhaps our accountant CEO is not as conservative as we thought....given this appeal seems all or nothing.
Baker Brothers--it will be interesting to see their ownership position later this week.
I would love to be a fly on the wall to hear their conversation with JT and executive team.
The Eastern District of Texas was often the favorite forum for patent owners to file their cases. Texas would have done right by us.
See this link: https://www.bloomberg.com/opinion/articles/2017-05-25/the-texas-town-that-patent-trolls-built-j34rlmjc
At any rate, this will come down to the judges. I agree with JL this is bigger than just the law at this point. We need those medical societies (AHA, ADA, etc.) to weigh in big here. Amarin needs to leave no stone unturned in outreach. Judges are human and they can be influenced. Think about how many Supreme Court cases are 5 to 4 all along political lines and beliefs of the judges.
As the old saying goes, a good lawyer knows the law, but a great lawyer knows the judge.
Don't fall for the legal minutiae this time around. It is all about the judges.
Reading the briefs will be an interesting intellectual exercise, but this will be about the judges.
Unreal indeed! SMH.
I hope Amarin will be reaching out to the medical organizations like the ADA and AHA and others to get help via amicus briefs. This is shaping up to be a huge fight with these generics coming forward.
With the public health implication (strokes / heart attacks, etc.) here for the USA will be interesting to see what is the FDA's stance if any.....
No sense in advertising as Thero alluded to if generics are just going to enter now and usurp all the hard work/R&D/$$$ Amarin put forth.
Just unreal
Judges....Judges....Judges. That is what is going to matter. Do not get fooled or caught up into the legal minutiae. This is all about getting the right judges. Sad but true.
Let's pray we get Judge Newman and other pro patent judges.
It is a shame we are in this situation. Our outcome for the USA unless a buyout rests in the hands of the judges. SMH
Joe Mimran--anyone know why he left the advisory board?
Well apparently our CEO is not afraid of litigation. He rolled the dice once and it looks like he is willing to do it again with the appeal.
Who knows what his lawyers are telling him about the chance of success with the appeal?
For sure, though, once the judges are revealed we will know where we stand during those oral arguments.
The Judges--Perhaps Amarin will wait to see which 3 judges will be hearing the case. That will be the tell all the day of oral arguments.
There was previous post a while back about which judges are pro-patent. We get any of those judges and it is game on.
Again all comes down to the judges. Judge Newman is one of the 3 we need. Pray we get her. We need Judge Newman.
Correct. The appeal will come down to the judges.
This is why Amarin should be doing all it can to get amicus curiae briefs from the medical organizations (ADA, AHA, etc.) and even other big pharma companies. As was mentioned on here, if this can happen to Amarin this can happen to other biotech companies as well. Hopefully they submit amicus briefs in support of Amarin.
Judges are human too and are political (think about how many Supreme Court decisions are 5 to 4). Important for the judges to realize the implications here especially to public health. Who will step up and support Amarin's efforts here...?
Will others submit amicus briefs....? We shall see.
I read the briefs for the district court trial numerous times.
I won't even bother reading the ones for the appellate trial because it will all come down to the judges. Look Amarin put forth compelling arguments last time and look where that got us.
It is time for us to wake up and realize litigation is risky and it will come down to the judges. You can say what you want about the law but that is reality. Sad but true.
We are a one product company.....cannot afford to pin this on getting the right judges this time around.
just my opinion.
Extremely risky as the appeal will come down to which judges hear the case.
Good luck with that in terms of banking it all on the appeal.
We all know how the first go round turned out.
Hoping you get the right judges it not a winnable strategy at this stage.
I agree. I reread the transcript. I think his talk of GIA in Europe is the ultimate head/pump fake. He mentioned holistic and value for shareholders numerous times. Seems like he is dropping nuggets of BO and maybe he is signaling to others to get your bids up.
Reread the transcript and pay attention to how many times he mentions holistic.
We need a settlement ASAP.
"The aim is to put ourselves in a position to be able to make the right decision for our shareholders based upon a number of different factors in a holistic manner for shareholder value."
"....a decision with regarding partnering in Europe will be a holistic decision, including many factors. And some of what you've described as considerations I would put under that holistic view of optionality and flexibility, but it's all this is in terms of creation of long-term value and we need to pull that together and see what makes the most sense for our shareholders by the time that we're making that decision."
"The U.S. litigation doesn't directly affect the approval in Europe, doesn't directly affect the market opportunity in Europe, doesn't affect the reimbursement directly in Europe. But it does reflect that holistic view of corporate value and optionality and all of those considerations will be put forward. At this point in time, we're continuing to develop relationships with key opinion leaders in Europe and appreciating the support there as evidenced by the two medical studies that have already included us and VASCEPA in their guidelines but continuing to advance scale for growth, doing some pharmacoeconomic analysis for reimbursement in Europe. And all of those inputs will also factor into our decision making. So, it is a holistic perspective."
"Again, at this point in time, we're just trying to let shareholders and all the parties know that we're evaluating and our aim is to do what is in the best interest of shareholders on a long-term basis from a holistic perspective."
Thanks HDGabor. Welcome back!
Baker Brothers--will be curious to see how much of AMRN they own when the new reports come out?
Wonder what they are telling or suggesting to JT at this point? Is he even listening. SMH
The call today surely left far more question than answers. If that was his goal, he succeeded.
Thero's response to Michael Yee's question:
Michael Yee
Wanted to follow-up on your commentary on the European process. If I go back, maybe a year or so ago, when all the U.S. FDA filing and the review was going on, you said you had a lot of European interest and I thought you said, maybe it was a dozen books or so. But maybe just remind us about the type of interest that is out there in Europe, because I get the sense that a lot of big companies these days are maybe less interested in cardiovascular and much more just oncology. So maybe just frame how much interest is there by big pharma and frame what happens in the third quarter? If you look at these things and you accept one of them or you are going to announce in the third quarter that you're hiring your own sales force and if it's the latter is expenses for launching the sales force in Europe in the guidance? Thanks so much.
John Thero
So with regard to interest in VASCEPA by big pharma, there is interest in VASCEPA by big pharma globally and right now we're focusing on Europe, Europe certainly no exception to that. We've had multiple companies doing diligence and I'm not going to get into numbers of companies and it really talks about terms, but this is a multi-billion dollar opportunity for a differentiated product. And there's companies that might say they're not into cardiovascular, but they're into metabolic or they're into diabetes, and generally they're into growth. And so we're seeing interest as to whether those companies will put forth terms that we feel would be appropriate, given the size of the opportunity and the stage of where its act of simply de-risk from a clinical perspective and largely de-risk from a regulatory perspective, we will see. The decision that you're asking me about in Q3, yes, framing in Q3, so hopefully we’d be in a position to decide are we going direct or are we partnering and if partnering hopefully to announce the terms of that are, and if we're going direct of way to outline some guidance as to what that means in terms of what would undoubtedly be update of a bit of a sequenced launch with emphasis on some of the larger countries first, in mid to small countries later and whether we would do some of those smaller countries directly or potentially with partners -- would be potentially flushed out at that point in time. And at this juncture, while we’ve withdrawn on our overall guidance for the year, including our previous quantification of operating expenses and talked about our -- the prior spending guidance volumes being too high relative to expenses is a pull back on the U.S. DTC, for example, that earlier your spending guidance, included some money for Europe, but did not include money for a significant launch in Europe.
That being said with approval for Europe, that would likely be somewhere near the end of this year. The launch in Europe would most likely be for a next year event rather than a year event. So possible for this year, but you get too close to the holidays and things and it's often just better to wait further for the New Year, that would all be -- hopefully be built out when we make a decision. Again, at this point in time, we're just trying to let shareholders and all the parties know that we're evaluating and our aim is to do what is in the best interest of shareholders on a long-term basis from a holistic perspective.
JT has alluded to the public health implication and the harm that could result if the public is not made aware of the benefits of Vascepa (limited market education).
The American Heart Association and the American Diabetes Association should submit amicus curiae briefs in addition to other organizations informing the judges of the unexpected results and medical need for Vascepa. Not to mention how non-obvious it was at the time. The question is will Amarin reach out to these organizations to solicit help? Time is of the essence.
Judges are human too and hearing from the ADA, AHA, and others could be beneficial to Amarin.
The public health aspect of this will likely be some component of the appeal (expedited nature as well). Although I hope there is a resolution as I am not looking forward to this hinging on the outcome of a trial. It will likely come down to the judges....very risky. We all know what happened the first time around. All comes down to the judges.
Agree. He was tap dancing around that.
LOL
Let's hope the Board or the big investors are encouraging JT to settle and he is receptive.
Surely hope someone can reach JT through a back channel and convey this.
Taking this to trial another time.....no bueno.
Excellent points!
Larrybirdlegend any update on how you see things playing out here?
The secret group of scientists and billionaires trying to stop COVID-19. This article is from today's WSJ. Hopefully someone from AMRN is in contact with them.
Article pasted below:
A dozen of America’s top scientists and a collection of billionaires and industry titans say they have the answer to the coronavirus pandemic, and they found a backdoor to deliver their plan to the White House.
The eclectic group is led by a 33-year-old physician-turned-venture capitalist, Tom Cahill, who lives far from the public eye in a one-bedroom rental near Boston’s Fenway Park. He owns just one suit, but he has enough lofty connections to influence government decisions in the war against Covid-19.
These scientists and their backers describe their work as a lockdown-era Manhattan Project, a nod to the World War II group of scientists who helped develop the atomic bomb. This time around, the scientists are marshaling brains and money to distill unorthodox ideas gleaned from around the globe.
They call themselves Scientists to Stop Covid-19, and they include chemical biologists, an immunobiologist, a neurobiologist, a chronobiologist, an oncologist, a gastroenterologist, an epidemiologist and a nuclear scientist. Of the scientists at the center of the project, biologist Michael Rosbash, a 2017 Nobel Prize winner, said, “There’s no question that I’m the least qualified.”
This group, whose work hasn’t been previously reported, has acted as the go-between for pharmaceutical companies looking for a reputable link to Trump administration decision makers. They are working remotely as an ad hoc review board for the flood of research on the coronavirus, weeding out flawed studies before they reach policy makers.
The group has compiled a confidential 17-page report that calls for a number of unorthodox methods against the virus. One big idea is treating patients with powerful drugs previously used against Ebola, with far heftier dosages than have been tried in the past.
The Food and Drug Administration and the Department of Veterans Affairs have already implemented specific recommendations, such as slashing manufacturing regulations and requirements for specific coronavirus drugs.
National Institutes of Health Director Francis Collins told people this month that he agreed with most of the recommendations in the report, according to documents reviewed by The Wall Street Journal and people familiar with the matter. The report was delivered to cabinet members and Vice President Mike Pence, head of the administration’s coronavirus task force.
Dr. Cahill’s primary asset is a young lifetime of connections through his investment firm. They include such billionaires as Peter Thiel, Jim Palotta and Michael Milken—financiers who afforded him the legitimacy to reach officials in the middle of the crisis. Dr. Cahill and his group have frequently advised Nick Ayers, Mr. Pence’s longtime aide, and agency heads through phone calls over the past month.
No one involved with the group stands to gain financially. They say they are motivated by the chance to add their own connections and levelheaded science to a coronavirus battle effort that has, on both state and federal levels, been strained.
“We may fail,” said Stuart Schreiber, a Harvard University chemist and a member of the group. “But if it succeeds, it could change the world.”
Steve Pagliuca, co-owner of the Boston Celtics and the co-chairman of Bain Capital—as well as one of Dr. Cahill’s investors—helped copy edit drafts of their report, and he passed a version to Goldman Sachs Group Inc. Chief Executive David Solomon. Mr. Solomon got it to Treasury Secretary Steven Mnuchin.
The group’s members say they are aware that many of their ideas may not be implemented, and could be ignored altogether by the Trump administration.
This account is based on interviews with scientists, businesspeople, government officials, as well as a review of related documents.
Break out
Only two years ago, Dr. Cahill was studying for his M.D. and PhD. at Duke University, conducting research on rare genetic diseases and wearing $20 Costco slacks. He assumed he would continue the work after graduation.
Instead, he reconnected with a friend who introduced him to a job at his father’s company, the blue-chip investment firm the Raptor Group.
Dr. Cahill got hooked on investing, particularly in life sciences. He reasoned he could make a bigger impact by identifying promising scientists and helping them troubleshoot problems—both scientific and financial—than doing research himself.
After a stint at Raptor, he formed his own fund, Newpath Partners, with $125 million from a small group of wealthy investors, including Silicon Valley stalwart Mr. Thiel and private-equity founders like Mr. Pagliuca. They were attracted to his blunt approach, as well as his interest in tackling intractable problems.
In early March, as the Covid-19 death toll mounted, Dr. Cahill was intrigued and a little depressed with the state of research on the virus. “Science and medicine were the furthest things removed from everything happening,” he said.
His investors peppered him with questions about the virus, and he organized a conference call to share some against-the-grain ideas on how to accelerate drug development and the like. He expected about 20 people.
When Dr. Cahill tried to dial in the meeting, he was rejected because the call had reached capacity. Then his cellphone buzzed from a New York number. It was National Basketball Association Commissioner Adam Silver. He, too, wanted the meeting’s access code. Dr. Cahill later gave him a personal briefing.
Newpath’s deep-pocketed investor base had spread word of the call, and hundreds of people were on the line, most of whom he had never met, including Mr. Milken.
When he finally got on the call, Dr. Cahill took a deep breath and said he had been working with friends to whittle down potential Covid-19 treatments to the most promising. He said he largely dropped his investing work to focus on a hunt for a cure.
After an hour, he hung up and found his email inbox full of ideas and offers to help, including from Mr. Milken’s team. “For the 50 years I’ve been involved in medical research I have never seen collaboration as we have today,” Mr. Milken said.
Dr. Cahill received a handful of notes from advisers to the vice president. They also had been on the call.
The scientist-investor had gained a platform. All he needed was a plan.
Tracing contacts
One of Dr. Cahill’s first calls was to Mr. Schreiber, a founder of several private companies.
Mr. Schreiber looped in a longtime friend, Edward Scolnick, former head of research and development at pharmaceutical giant Merck & Co., where he helped develop 28 new drugs and vaccines. Dr. Scolnick was blunt: A vaccine would take at least 18 months to hit the market under normal circumstances, he told Mr. Schrieber, “if you’re damn lucky.”
Mr. Schreiber responded, “What about six months?”
The team drew up a list of roughly two dozen companies that could benefit from their recommendations and pledged to sell any shares in them immediately. One early member said he couldn’t and was kicked out.
Share Your Thoughts
What is your assessment of the group’s Covid-19 plan?Join the conversation below.
Much of the early work involved divvying up hundreds of scientific papers on the crisis from around the world. They separated promising ideas from dubious ones. Each member blazed through as many as 20 papers a day, around 10 times the pace they would in their day jobs. They gathered to debate via videoconference, text messages—“like a bunch of teenagers,” Mr. Rosbash said—and phone calls.
Personal hygiene went by the wayside. Michael Lin, a Stanford University neurobiologist, began disabling the camera on his phone to protect his vanity. “A couple of days, I’ve had 7 or 8 Zoom meetings, which will itself I’m sure cause some kind of disease,” he joked.
Debates haven’t always been purely science. The group discussed, for instance, whether to suggest that public-health authorities rename the virus “SARS-2,” after the 2003 China animal virus. To them, the name sounded scarier and might get more people to wear face masks. They dropped it.
The team pledged to try to block out politics—not an easy task in the noise and fury of a presidential election year.
Hydroxychloroquine, a malaria drug promoted by the president, was dismissed after the group’s resident expert, Ben Cravatt of Scripps Research in La Jolla, Calif., determined it was a long shot at best. The drug received only a passing mention in the group’s final report.
Hydroxychloroquine pills.
Photo: John Locher/Associated Press
The group also disparaged the idea of using antibody testing to allow people back to work if their results showed they had recovered from the virus. Mr. Cravatt, a chemical biologist, declared it “the worst idea I’ve ever heard.” He said that prior exposure may not prevent people from giving the virus to others, and that overemphasizing antibody testing might tempt some people to intentionally infect themselves to later obtain a clean bill of health.
The group’s initial three phases of recommendations, contained in its report, center on leveraging the scale of the federal government. For instance, buy medicines not yet proven effective as a way to encourage manufacturers to ramp up production without worrying about losing money if the drugs fail. Another is to slash the time required for a clinical review of new drugs to a week from nine months or a year.
The group next needed to get their recommendations to the right people in the Trump administration. For that, Dr. Cahill tapped another well-placed billionaire.
An introduction
Brian Sheth, co-founder of private-equity firm Vista Equity Partners, and a Democrat, had been watching the effort gather steam from his home in Austin, Texas. He was an early investor in Dr. Cahill’s fund and had been on the first call. His expertise was technology, though, not immunology.
He had become friendly with Thomas Hicks Jr., the Dallas businessman and co-chairman of the Republican National Committee. Mr. Sheth introduced Mr. Hicks to Dr. Cahill’s group.
The connection cinched ties between a group of mostly liberal scientists from left-leaning institutions with a Republican stalwart who hunts birds with Donald Trump Jr.
In his first chat with the group, Mr. Hicks said, “I’m not a scientist. Make it clear enough for me, and then tell me where the red tape is.”
A major concern of the scientists was the FDA. The scientists had in their research identified monoclonal antibody drugs that latch onto virus cells as the most promising treatment. But to make the medicine in sufficient quantities, one drugmaker, Regeneron Pharmaceuticals Inc., would have to shift some of its existing manufacturing to Ireland. FDA rules required a monthslong wait for approval.
Mr. Scolnick, who had tussled with bureaucracy during the AIDS epidemic, tried reaching the FDA. The call ended poorly after the bureaucrats told the group they already had the pandemic under control. In a group call afterward, one of the scientists said, of the FDA: “They’re the problem here.”
Why Blood From Coronavirus Survivors Could Be a Lifeline for the Sick
A growing number of hospitals are investigating antibody testing and blood plasma therapy as a way to combat the new coronavirus in sick patients. WSJ’s Daniela Hernandez explains. Photo illustration: Laura Kammermann
Dr. Cahill got in touch with Mr. Ayers. Once the group briefed the vice president’s aide on the bottleneck, Mr. Ayers said he knew who to call. That evening, March 27, Regeneron received a call from the FDA. They had permission, starting immediately, to shift production to Dublin.
“That was proof positive that what we were doing was starting to work,” Mr. Rosbash said.
The group also made inroads with the VA, the largest health care system in the U.S. The scientists pushed the division’s medical staff to allow veterans with Covid-19 to join existing studies in such areas as prostate cancer, to see if already-approved drugs might be effective against the virus. They spoke to the VA’s chief medical officer and secretary about the proposal and learned the initiative was being fast-tracked.
Mr. Pagliuca spoke to Charles Baker, the Republican governor of Massachusetts, on the phone about the report. The governor, Mr. Pagliuca said, planned to adopt elements of the plan.
With much of their scientific proposals under advisement, or already in the process, the group has an eye on the post-Covid-19 world. Mr. Pagliuca pushed the scientists to add a fourth phase to the plan—reopening America.
The ideas include development of a saliva test, and scheduling such test at the end of the workday so results are available by morning. They also have suggested a nationwide smartphone app that requires residents to confirm each day that they don’t have any of 14 symptoms of a cold or fever.
Group members have continued their discussions with administration officials in recent days, hoping their confidential plan turns to action.
“We need the entire nation—government, business and science—to unite to defeat this,” Mr. Pagliuca said.
Write to Rob Copeland at rob.copeland@wsj.com
Why is her decision a black eye for women and minorities?
Her decision is just a black eye for the judicial system. It has nothing to do with women and minorities.
There are good decisions and there are bad decisions made by judges of every ethnicity.
Would you say another judge's decision is a black eye for his / her race?
SMH
Our lead lawyer's former client was also Gilead.
Perhaps just a coincidence but all very interesting....
One can only speculate if Gilead recommended Jonathan Singer
https://www.fr.com/jonathan-e-singer/