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Things do NOT add up regarding the stated results and the cancellation of the ongoing testing. As typical, it takes time for questions to be answered. Here is an interesting article that may provide a "peek" into some questionable connections. Could this be about class action suits and sheltering people? Or is it stock manipulation? Is it a part of the ongoing bad blood between NRXP and RLFTF and those negotiations? This may take time to get to the bottom...
https://www.politico.com/news/2020/09/17/andy-harris-coronavirus-neurorx-board-417329
Mask skeptic lawmaker takes on side gig overseeing drug company trial
Several bioethicists question Rep. Andy Harris' lack of experience.
Rep. Andy Harris
Rep. Andy Harris is one of three members of the data and safety monitoring board for the trial run by NeuroRx, a small Delaware company whose CEO and founder has longstanding ties to the congressman. | Al Drago/Pool via AP
By ZACHARY BRENNAN
09/17/2020 06:13 PM EDT
Rep. Andy Harris, a Maryland Republican and medical doctor, has broken with the scientific mainstream during the coronavirus pandemic — decrying stay-at-home orders and warning of a “cult of masks.”
Now the five-term congressman has joined the hunt for coronavirus treatments with an unpaid side gig overseeing a drug company trial. Harris is one of three members of the data and safety monitoring board for the trial run by NeuroRx, a small Delaware company whose CEO and founder has longstanding ties to the congressman.
The members of the board are responsible for monitoring safety and efficacy data from the ongoing trial, which started in May, and have the power to end the study if problems arise. The drug in question, aviptadil, was created in 1970 to treat lung inflammation, but never reached the market. NeuroRx is now investigating whether it can help Covid-19 patients with acute lung failure.
Harris’s role is an unusual one: Former FDA Commissioner Scott Gottlieb told POLITICO that he’d never heard of a sitting member of Congress serving on a data monitoring committee for any drug. The arrangement doesn’t appear to run afoul of House ethics rules because Harris is not being paid by NeuroRx and does not own a stake in the company. But several bioethicists questioned his lack of experience in evaluating data from drug trials, and said that his close ties to NeuroRx CEO Jonathan Javitt could complicate matters if problems arose with the company’s study.
“The concern about bias wouldn’t arise unless the decision-making [on data from the trial] was difficult,” said Susan Ellenberg, a biostatistician at the University of Pennsylvania, whose research focuses on the ethical issues related to clinical trials. “If the data are such that it’s a hard call as to whether to stop the study or not, that’s when the personal connections seep into consciousness,” added Ellenberg, a former FDA staffer who wrote the agency’s guidance document on data monitoring committees.
In a statement to POLITICO, Harris — an anesthesiologist who still practices part-time — brushed aside any suggestion that he is not qualified to serve on the data board.
“I have a Master of Health Science degree from the Hopkins school of public health, which involves training in biostatistics (that’s a matter of public record, which you probably already knew),” he said. “I have been an investigator on numerous NIH grants and published numerous papers that involved complex statistical analysis, and have been involved in clinical research studies as a principal investigator.”
The congressman said that he plans to report the NeuroRx position on his next annual ethics filing, which is due in May, and that he does not interact with FDA as part of his data board service. He did not respond to a question about whether he had sought advice from the House Ethics Committee on the NeuroRx role before he had accepted it.
null“My only hope was to volunteer my expertise to help America find our way out of this pandemic, as every American who has a skill set to offer hopefully should be willing to do,” Harris said in his statement.
Harris met NeuroRx’s CEO, Javitt, more than two decades ago when they worked together at Johns Hopkins University. Javitt was then a surgeon, while Harris specialized in obstetric anesthesiology.
The two have kept in touch over the years. Javitt, who donated $2,000 to Harris’s campaign in 2010, said he’d visited Harris at his House office in recent years to discuss NeuroRx’s other drug in development, for suicidal bipolar depression.
Javitt — who is also vice chairman of the board of directors at Relief Therapeutics, which holds the patent on aviptadil — told POLITICO that he selected Harris for the data committee because of the congressman’s experience in critical care settings. Javitt also said that the FDA signed off on the trial knowing that Harris would be involved with the committee.
The aviptadil trial started in May at four U.S. sites, and aims to enroll more than 100 participants. The FDA has granted the drug “fast track” status, which is designed to speed the availability of drugs to treat serious diseases. NeuroRx is also offering aviptadil through an FDA-approved expanded access program for hospitalized patients at the same sites in Houston, Kentucky, Florida and California that are hosting the current trial.
The data board that Harris is part of has already made at least one crucial decision — recommending in July that the trial continue after analyzing preliminary data from 30 patients, Relief Therapeutics said in press release this week.
FDA’s guidance for data monitoring committees recommends that at least one member is a “biostatistician knowledgeable about statistical methods for clinical trials and sequential analysis of trial data.” But neither Harris nor the other two members of the NeuroRx panel fit that bill.
Alfred Sommer is the dean emeritus of the Johns Hopkins Bloomberg School of Public Health, with training in ophthalmology and epidemiology. Rita Colwell, an aquatic biologist, led the National Science Foundation under presidents Bill Clinton and George W. Bush. She now holds joint appointments at the University of Maryland and Johns Hopkins.
Colwell told POLITICO that she had served on data monitoring committees for other clinical trials. Sommer and Harris had never done so before joining the NeuroRx panel.
But all three of the NeuroRx panel members have professional or personal relationships with Javitt. Sommer, the chair of the data committee, worked with Javitt at Johns Hopkins; the pair have known each other for about 40 years. Javitt met Colwell during her tenure leading NSF, when he was a fellow at the non-profit Potomac Institute for Policy Studies providing support to the agency.
“It seems like a strange collection of people and when you think about the documents this committee would need to review — are they going to understand the adverse event reports? You want them to be informed enough to ask questions on if the adverse events are caused by the drug,” said Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics.
In some cases, the data monitoring board for a trial would be faced with deciding whether to stop that study. “You don’t want three well-intentioned friends being spoon-fed information from the trial and who can’t look at it critically,” Turner added.
Ellenberg -- who wrote the FDA guidelines for data monitoring committees while on staff at the agency -- echoed those concerns. “Neither Harris nor Colwell is known for clinical trials expertise,” she said. “Members of a DMC should all be very familiar with clinical trials.”
Javitt said that an outside biostatistician is working with the committee, but is not a member of it. He also downplayed the panel’s role in the trial. “Unless there are unexpected severe adverse events to take action on, the committee doesn’t have much to do,” he said.
Asked specifically about the unusual decision to include a sitting member of Congress on the data monitoring board, Javitt said it shows Harris’ commitment to fighting the coronavirus and finding effective treatments.
Holly Fernandez-Lynch, an assistant professor of bioethics at the University of Pennsylvania’s Perelman School of Medicine, said there is no shortage of specialists in critical-care medicine who have the biostatistics skills to serve on a Covid-19 drug data monitoring committee.
“Other COVID drugs — and there are many under study — presumably have done so without going to members of Congress,” she said.
Walter Shaub, the former director of the Office of Government Ethics, said “it’s concerning” that Harris is involved with a company regulated by FDA, given his position on the House appropriations subcommittee that controls the agency’s purse. “FDA officials may feel nervous about holding the company to high standards if a member of their appropriations subcommittee is involved in the trial,” he said.
Still, Harris’s involvement with NeuroRx does not appear to violate House ethics rules.
“The only thing that’s prohibited is outside earned income,” said Richard Painter, the former chief ethics lawyer for President George W. Bush who is now a law professor at the University of Minnesota. “House ethics rules are pretty loosey goosey.”
Painter said that Harris should recuse himself from any bills targeted at NeuroRx, but not necessarily the pharmaceutical industry as a whole. He also said that the congressman should recuse himself “from any company involvement with the FDA,” including any interventions on NeuroRx’s behalf.
But Henry Greely, a law professor and chair of the steering committee of the Center for Biomedical Ethics at Stanford University, saw no obvious problems arising from Harris’s work with NeuroRx.
“It’s strange but I don’t think it’s an ethical issue unless Harris tries to use his influence with FDA on behalf of the company,” Greely said. “It would be a closer question for me if he were somehow generally advising the firm, but a [data monitoring board] has a pretty discrete and specific task.”
Huge shorting... apparently they are not worried about being "GameStopped!"
So big pharma... Pfizer received an emergency use authorization for Paxlovid before any real proof that it actually works! The FDA has some serious corruption and it is affecting the health of Americans. Government run agencies are not exactly full of the brightest and best of people. Political influence, graft, corruption and special future employment favors... all influence their decisions.
Pfizer Inc. slumped after Paxlovid, its pill for treating Covid-19, failed to show benefit as a preventive therapy in a trial.
https://finance.yahoo.com/news/pfizer-falls-covid-pill-fails-130238318.html
"Paxlovid is poised to become one of the fastest-selling drugs of all time, with $24 billion in projected 2022 sales, according to analytics group Airfinity Ltd. Pfizer has also reaped billions in global sales from its Covid-19 vaccine.
The company said late Friday that the drug failed to hit its main goal of reducing the risk that adults exposed to the coronavirus through contact with a household member would become infected. Compared with those who took a placebo, people who received Paxlovid had about a third less risk of infection, which wasn’t statistically significant.
The shares fell 2.2% at 9:36 a.m. in New York. They had declined 17% this year through Friday’s close.
The trial failure, along with reports of rebounding coronavirus levels in some patients who have completed a course of Paxlovid, are unlikely to change the drug’s sales potential, according to Bloomberg Intelligence analysts John Murphy and Sam Fazeli.
“The trial miss at most takes away a small incremental sales opportunity in future years,” they said Monday in a research note. The reports of rebound infections are “also not surprising as viral dynamics during an infection are unlikely to fit perfectly with a rigid 5-day course.”
Morgan Stanley analysts, who had estimated the drug’s sales to reach $48 billion in 2022, said the prophylaxis data might affect their forecast."
So big pharma... Pfizer received an emergency use authorization for Paxlovid before any real proof that it actually works! The FDA has some serious corruption and it is affecting the health of Americans. Government run agencies are not exactly full of the brightest and best of people. Political influence, graft, corruption and special future employment favors... all influence their decisions.
Pfizer Inc. slumped after Paxlovid, its pill for treating Covid-19, failed to show benefit as a preventive therapy in a trial.
https://finance.yahoo.com/news/pfizer-falls-covid-pill-fails-130238318.html
"Paxlovid is poised to become one of the fastest-selling drugs of all time, with $24 billion in projected 2022 sales, according to analytics group Airfinity Ltd. Pfizer has also reaped billions in global sales from its Covid-19 vaccine.
The company said late Friday that the drug failed to hit its main goal of reducing the risk that adults exposed to the coronavirus through contact with a household member would become infected. Compared with those who took a placebo, people who received Paxlovid had about a third less risk of infection, which wasn’t statistically significant.
The shares fell 2.2% at 9:36 a.m. in New York. They had declined 17% this year through Friday’s close.
The trial failure, along with reports of rebounding coronavirus levels in some patients who have completed a course of Paxlovid, are unlikely to change the drug’s sales potential, according to Bloomberg Intelligence analysts John Murphy and Sam Fazeli.
“The trial miss at most takes away a small incremental sales opportunity in future years,” they said Monday in a research note. The reports of rebound infections are “also not surprising as viral dynamics during an infection are unlikely to fit perfectly with a rigid 5-day course.”
Morgan Stanley analysts, who had estimated the drug’s sales to reach $48 billion in 2022, said the prophylaxis data might affect their forecast."
Right... sorry I was talking about NRX....which could also affect RLFTF. So still then institutional holders could be and influence. They certainly carry more weight than my meager holdings.
Well... The deadline has passed for the FDA to reply to the congressional demand letter... But, if the response was made public then for sure, and no matter if it was a positive or negative response, either way it would affect the share price. So will we ever know until it is a "go or no go" from the FDA? Seems we are stuck by the rules of insider information.
As to the halt of the case to negotiate. I think that is a good thing. There are a lot of institutional investors who carry a lot of leverage and I am sure they are not happy over all this. I think they want them to stop kicking the can down Wall street..
A friend of mine sent this to me:
New court doc from RLFTF board by IG states that both sides are making progress and request a stay of the proceedings while they continue to work through mediation.
https://iapps.courts.state.ny.us/nyscef/ViewDocument?docIndex=FcZfoGTkugRo6zR3yNzM9w==
A friend of mine sent this to me:
New court doc from RLFTF board by IG states that both sides are making progress and request a stay of the proceedings while they continue to work through mediation.
https://iapps.courts.state.ny.us/nyscef/ViewDocument?docIndex=FcZfoGTkugRo6zR3yNzM9w==
Sorry to hear that... Not that much for me, but I am into both companies. I have recovered from this situation in the past with other stocks. At some point if the share price gets really cheap ( I mean cheap... pennies) and you believe you will not see chapt 7 or 11... I have more than tripled down really lowering the average. It did not really add to the total loss that much if BK hit. But I got in no where near the 50 pps with this stock.. Not sure what I would do then with a really high average.. It would take a lot more money to avg down even if it did hit pennies. You would have to estimate a long term recovery SP...and calculate from there. There are professionals who could advise... I am still hanging in there. Good luck to all!
So the deadline for the FDA to reply to the Senator's questions was March 17, 2022.
Are they ignoring the authority of the congress? Is this a political war?
If you are saying that Democrats will not give into a Republican originated demand letter... If they do that over considerations of saving lives of Americans...then they are sick! If that is the case... then all polls are showing that Democrats will be out of power again after the 2022 mid term elections. There is that.
If you are saying that Democrats will not give into a Republican originated demand letter... If they do that over considerations of saving lives of Americans...then they are sick! If that is the case... then all polls are showing that Democrats will be out of power again after the 2022 mid term elections. There is that.
Joe... We have seen similar results posted.... But isn't this latest a new release and a new addendum to the FDA for EUA evaluation? The report included a statement that this info will reset the 60 day time clock for the FDA evaluation. Thoughts? Thanks....
I am thinking that secrecy is the security that will save face. We will probably not be told unless the negotiations are fruitless.
Together they are stronger.... so all we can hope is that pride does not spoil the prize.
Current... Meaning? Not sure what you mean sorry.. But I find it interesting that no news has been released regarding court action etc.. Unless I missed it.. I am just here with very few cheap shares waiting for them to become totally worthless.. as if they aren't already!
Current... Meaning? Not sure what you mean sorry.. But I find it interesting that no news has been released regarding court action etc.. Unless I missed it.. I am just here with very few cheap shares waiting for them to become totally worthless.. as if they aren't already!
Money, power and ego corrupt...
Part 2
The whole market tanked.... Considering what is going on with everything...it is no surprise..
FDA Exec on Camera Reveals Future COVID Policy
by Project Veritas.
Apparently The FDA will approve a drug if they get paid enough to do so! Perhaps that is why we are waiting so long. This is disgusting!
FDA Exec on Camera Reveals Future COVID Policy
by Project Veritas.
Apparently The FDA will approve a drug if they get paid enough to do so! Perhaps that is why we are waiting so long. This is disgusting!
A friend of mine sent me this... It mentions Aviptadil as one of the last standing studies. Big pharm has failed to compete..
Sorry if already posted!
https://www.fiercebiotech.com/biotech/pfizer-a-rare-covid-19-setback-dumps-paxlovid-s-intravenous-sibling-to-leave-activ-3-future
Pfizer, in a rare COVID-19 setback, dumps Paxlovid's intravenous sibling in further blow to ACTIV-3
by Nick Paul Taylor | Feb 8, 2022 8:20am
Add Pfizer to the long list of victims of ACTIV-3. While the Big Pharma has enjoyed unparalleled success in COVID-19, it was unable to buck the trend in the National Institutes of Health (NIH) study of hospitalized patients and has stopped development of Paxlovid’s intravenous sibling PF-07304814.
The NIH set up ACTIV-3 to test anti-SARS-CoV-2 monoclonal antibodies and other therapies in patients hospitalized with COVID-19. Brii Biosciences, Eli Lilly, GlaxoSmithKline and Novartis are among the drug developers to contribute candidates to the study. All those candidates failed to move the needle in hospitalized patients with severe COVID-19, resulting in a persistent unmet need even as the broader pandemic armory has gone from strength to strength.
PF-07304814 represented a different answer to the question of how to treat severe COVID-19. Like one of the components of Pfizer’s oral COVID-19 drug Paxlovid, PF-07304814 is a SARS-CoV-2 main protease inhibitor. The idea was to expand into patients with severe COVID-19 through intravenous delivery.
That plan, like others tested by Pfizer’s peers, came unstuck in NIH’s ACTIV-3 trial. Dosing of the intravenous antiviral in the trial has stopped, and Pfizer has discontinued the global clinical development. Pfizer said the decision “was made based on a totality of information, including a careful review of early data and a thorough assessment of the candidate’s potential to successfully fulfill patient needs.”
RELATED: Novartis-partnered DARPin flames out in COVID-19 study
The discontinuation means ACTIV-3 is no longer enrolling patients. In a recent update to the listing on ClinicalTrials.gov, the sponsor changed the status from “recruiting” to “active, not recruiting” and added “Suspended: Participants are not currently being randomized to this intervention” to the description of the PF-07304814 arm. Patients aren’t being randomized into any of the other arms, either.
ACTIV-3 has been a rare graveyard for COVID-19 programs. The global vaccine race and push to create therapies for mild to moderate COVID-19 each featured multiple successes. But efforts to improve on Gilead Sciences' Veklury in hospitalized COVID-19 patients have floundered, potentially because by that point in the disease pathway elements other than the virus are at play. The NIH is still pushing ahead, though.
"The ACTIV-3 program has not ended. The ACTIV-3 inpatient protocol is no longer enrolling participants to receive PF-07304814. However, ACTIV-3b, also known as the ACTIV-3 critical care protocol, continues to randomize participants to receive aviptadil. Looking ahead, ACTIV-3 partners are considering ways to evolve to evaluate different treatment strategies based on different stages of disease," a spokesperson for the National Institute of Allergy and Infectious Diseases said.
Pfizer disclosed the discontinuation of PF-07304814 in its quarterly pipeline update. The Big Pharma also used the update to reveal the end of work on PRMT5 inhibitor PF-06939999 in solid tumor patients and PF-07059013 in sickle cell disease. Both programs were in phase 1.
Editor's note: This story was updated at 05:10 a.m. ET on Feb. 9 to include information from the NIAID.
A friend of mine sent me this... It mentions Aviptadil as one of the last standing studies. Big pharm has failed to compete..
Sorry if already posted!
https://www.fiercebiotech.com/biotech/pfizer-a-rare-covid-19-setback-dumps-paxlovid-s-intravenous-sibling-to-leave-activ-3-future
Pfizer, in a rare COVID-19 setback, dumps Paxlovid's intravenous sibling in further blow to ACTIV-3
by Nick Paul Taylor | Feb 8, 2022 8:20am
Add Pfizer to the long list of victims of ACTIV-3. While the Big Pharma has enjoyed unparalleled success in COVID-19, it was unable to buck the trend in the National Institutes of Health (NIH) study of hospitalized patients and has stopped development of Paxlovid’s intravenous sibling PF-07304814.
The NIH set up ACTIV-3 to test anti-SARS-CoV-2 monoclonal antibodies and other therapies in patients hospitalized with COVID-19. Brii Biosciences, Eli Lilly, GlaxoSmithKline and Novartis are among the drug developers to contribute candidates to the study. All those candidates failed to move the needle in hospitalized patients with severe COVID-19, resulting in a persistent unmet need even as the broader pandemic armory has gone from strength to strength.
PF-07304814 represented a different answer to the question of how to treat severe COVID-19. Like one of the components of Pfizer’s oral COVID-19 drug Paxlovid, PF-07304814 is a SARS-CoV-2 main protease inhibitor. The idea was to expand into patients with severe COVID-19 through intravenous delivery.
That plan, like others tested by Pfizer’s peers, came unstuck in NIH’s ACTIV-3 trial. Dosing of the intravenous antiviral in the trial has stopped, and Pfizer has discontinued the global clinical development. Pfizer said the decision “was made based on a totality of information, including a careful review of early data and a thorough assessment of the candidate’s potential to successfully fulfill patient needs.”
RELATED: Novartis-partnered DARPin flames out in COVID-19 study
The discontinuation means ACTIV-3 is no longer enrolling patients. In a recent update to the listing on ClinicalTrials.gov, the sponsor changed the status from “recruiting” to “active, not recruiting” and added “Suspended: Participants are not currently being randomized to this intervention” to the description of the PF-07304814 arm. Patients aren’t being randomized into any of the other arms, either.
ACTIV-3 has been a rare graveyard for COVID-19 programs. The global vaccine race and push to create therapies for mild to moderate COVID-19 each featured multiple successes. But efforts to improve on Gilead Sciences' Veklury in hospitalized COVID-19 patients have floundered, potentially because by that point in the disease pathway elements other than the virus are at play. The NIH is still pushing ahead, though.
"The ACTIV-3 program has not ended. The ACTIV-3 inpatient protocol is no longer enrolling participants to receive PF-07304814. However, ACTIV-3b, also known as the ACTIV-3 critical care protocol, continues to randomize participants to receive aviptadil. Looking ahead, ACTIV-3 partners are considering ways to evolve to evaluate different treatment strategies based on different stages of disease," a spokesperson for the National Institute of Allergy and Infectious Diseases said.
Pfizer disclosed the discontinuation of PF-07304814 in its quarterly pipeline update. The Big Pharma also used the update to reveal the end of work on PRMT5 inhibitor PF-06939999 in solid tumor patients and PF-07059013 in sickle cell disease. Both programs were in phase 1.
Editor's note: This story was updated at 05:10 a.m. ET on Feb. 9 to include information from the NIAID.
A friend of mine sent me this... It mentions Aviptadil as one of the last standing studies. Big pharm has failed to compete..
Sorry if already posted!
https://www.fiercebiotech.com/biotech/pfizer-a-rare-covid-19-setback-dumps-paxlovid-s-intravenous-sibling-to-leave-activ-3-future
Pfizer, in a rare COVID-19 setback, dumps Paxlovid's intravenous sibling in further blow to ACTIV-3
by Nick Paul Taylor | Feb 8, 2022 8:20am
Add Pfizer to the long list of victims of ACTIV-3. While the Big Pharma has enjoyed unparalleled success in COVID-19, it was unable to buck the trend in the National Institutes of Health (NIH) study of hospitalized patients and has stopped development of Paxlovid’s intravenous sibling PF-07304814.
The NIH set up ACTIV-3 to test anti-SARS-CoV-2 monoclonal antibodies and other therapies in patients hospitalized with COVID-19. Brii Biosciences, Eli Lilly, GlaxoSmithKline and Novartis are among the drug developers to contribute candidates to the study. All those candidates failed to move the needle in hospitalized patients with severe COVID-19, resulting in a persistent unmet need even as the broader pandemic armory has gone from strength to strength.
PF-07304814 represented a different answer to the question of how to treat severe COVID-19. Like one of the components of Pfizer’s oral COVID-19 drug Paxlovid, PF-07304814 is a SARS-CoV-2 main protease inhibitor. The idea was to expand into patients with severe COVID-19 through intravenous delivery.
That plan, like others tested by Pfizer’s peers, came unstuck in NIH’s ACTIV-3 trial. Dosing of the intravenous antiviral in the trial has stopped, and Pfizer has discontinued the global clinical development. Pfizer said the decision “was made based on a totality of information, including a careful review of early data and a thorough assessment of the candidate’s potential to successfully fulfill patient needs.”
RELATED: Novartis-partnered DARPin flames out in COVID-19 study
The discontinuation means ACTIV-3 is no longer enrolling patients. In a recent update to the listing on ClinicalTrials.gov, the sponsor changed the status from “recruiting” to “active, not recruiting” and added “Suspended: Participants are not currently being randomized to this intervention” to the description of the PF-07304814 arm. Patients aren’t being randomized into any of the other arms, either.
ACTIV-3 has been a rare graveyard for COVID-19 programs. The global vaccine race and push to create therapies for mild to moderate COVID-19 each featured multiple successes. But efforts to improve on Gilead Sciences' Veklury in hospitalized COVID-19 patients have floundered, potentially because by that point in the disease pathway elements other than the virus are at play. The NIH is still pushing ahead, though.
"The ACTIV-3 program has not ended. The ACTIV-3 inpatient protocol is no longer enrolling participants to receive PF-07304814. However, ACTIV-3b, also known as the ACTIV-3 critical care protocol, continues to randomize participants to receive aviptadil. Looking ahead, ACTIV-3 partners are considering ways to evolve to evaluate different treatment strategies based on different stages of disease," a spokesperson for the National Institute of Allergy and Infectious Diseases said.
Pfizer disclosed the discontinuation of PF-07304814 in its quarterly pipeline update. The Big Pharma also used the update to reveal the end of work on PRMT5 inhibitor PF-06939999 in solid tumor patients and PF-07059013 in sickle cell disease. Both programs were in phase 1.
Editor's note: This story was updated at 05:10 a.m. ET on Feb. 9 to include information from the NIAID.
So why was this written? And... why has ABWN not filed for chapt 7 or 11? Or did I miss it?
Too bad about all this. It was and still could be a viable option to gap communications means.
Fortunately I bought mine at the bottom... but understand how so many who did not are filing suit. I am just hanging on to see what happens. Maybe the ABWN name is worth a few bucks to someone! LOL
https://industrialit.com.au/aircraft-communication-system-market-share-growing-rapidly-with-recent-trends-development-revenue-demand-and-forecast-to-2026/
Thanks for posing that. Interesting that they mentioned NRX as a partner. I hope both companies get their acts together. The legal bickering is not helping either of them.
In part from the application filing:
RLF-100TM is currently late-stage clinical testing in the U.S for acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) associated with the SARS-CoV-2 virus (COVID-19) through Relief's collaboration partner in the U.S., NeuroRx, Inc. VIP has been granted Fast Track Designation by FDA for the treatment of critical COVID-19 patients with respiratory failure.
Posting this to both boards..
If they would take their disagreements behind closed doors via conflict resolution... put egos aside... then they both stand much more to gain working together rather than publicly bitch slapping each other. They both owe that to all us shareholders.
And still... as a safety fuse... If you look at the past price of NRX going back from the IPO in 2018 all the way up to Dec 2020, it averaged 10 to 11 bucks per share. RLFTF was also higher going back last year till the FDA did not act on approval. So to me there is a possibility that these two positions still hold some old inherent value aside from the current therapeutics at hand. There is also Brilife and other products on the table waiting in the wings.
Not sure if short selling and manipulating is happening... but for sure there is a lack of confidence... for now.
Posting this to both boards..
If they would take their disagreements behind closed doors via conflict resolution... put egos aside... then they both stand much more to gain working together rather than publicly bitch slapping each other. They both owe that to all us shareholders.
And still... as a safety fuse... If you look at the past price of NRX going back from the IPO in 2018 all the way up to Dec 2020, it averaged 10 to 11 bucks per share. RLFTF was also higher going back last year till the FDA did not act on approval. So to me there is a possibility that these two positions still hold some old inherent value aside from the current therapeutics at hand. There is also Brilife and other products on the table waiting in the wings.
Not sure if short selling and manipulating is happening... but for sure there is a lack of confidence... for now.
As you stated: "The drug works! The word is getting out slowly."
Too slowly. But...
Wish there was a way to fund a billboard outside FDA headquarters!
Something simple... --- ZYESAMI --- Ventilated Covid patients are dying because ZYESAMI is being ignored! Ask your Doctor... save a life...
Great question... Is it the inherent slow grind of a typical government organization. They do not have to worry about making a profit! It is amazing how they actually sped up the approval of three vaccines... yet, I do not think the Biden admin is too interested in pressuring anyone to speed things up.
But Rand Paul has some interesting observations...
https://www.dailymail.co.uk/news/article-10350179/Rand-Paul-says-Fauci-responsible-THOUSANDS-COVID-deaths.html
Rand Paul says Fauci is responsible for THOUSANDS of COVID deaths across the US because he 'deemphasized therapeutics' while focusing entirely on vaccines
The Kentucky Republican accused Fauci of having a 'bias' toward vaccines that dates back to the AIDS crisis
'I would venture to say that thousands of people die in our country every month now because [Fauci's] deemphasized the idea that there are therapeutics'
The senator also claimed that thousands had died because Fauci did not take into account natural immunity in prioritizing vaccinations
The CDC recommends that all people be fully vaccinated regardless of previous infection
Great question... Is it the inherent slow grind of a typical government organization. They do not have to worry about making a profit! It is amazing how they actually sped up the approval of three vaccines... yet, I do not think the Biden admin is too interested in pressuring anyone to speed things up.
But Rand Paul has some interesting observations...
https://www.dailymail.co.uk/news/article-10350179/Rand-Paul-says-Fauci-responsible-THOUSANDS-COVID-deaths.html
Rand Paul says Fauci is responsible for THOUSANDS of COVID deaths across the US because he 'deemphasized therapeutics' while focusing entirely on vaccines
The Kentucky Republican accused Fauci of having a 'bias' toward vaccines that dates back to the AIDS crisis
'I would venture to say that thousands of people die in our country every month now because [Fauci's] deemphasized the idea that there are therapeutics'
The senator also claimed that thousands had died because Fauci did not take into account natural immunity in prioritizing vaccinations
The CDC recommends that all people be fully vaccinated regardless of previous infection
Good perspective... Yeah... to me it doesn't matter what you name a coin, they all have to be backed by a recognized currency or you can't buy any so in essence, they are all the same in that regard and it all depends on what you want to call your means of $$ storage. Exchange calculations make them all equally tradable just like physical paper money.
I guess it will end up being a race like it was for BETA and VHS...the market will determine the winner. But for now it does not matter what means you pay for something with as long as there is trust in the perceived value.
But for now..and I could be wrong, all this is just the race for a fully digitally stored paperless economic system. Walk into a store and walk out, no register and paid for with auto pay deduction. Or you can just smash and grab!
Normally I keep quiet here and watch and learn... But on any investment (mine are mostly regular stock positions and I am just tinkering here with coin) one can remember times where you had to average down and wished you had waited for a lower $$. A very normal situation since it is really difficult to see into the future.
Yet, I have never seen a time when the entire market has fallen (crashed) all in unison and then after buying in at the new panicked lows, (blood in the streets) I made some huge cash in the long run recovery.
So, here we sit.. the entire coin group has all fallen off a short cliff... and somehow I feel strangely comforted by that... as opposed to if Shib was the only one taking the dive. I mean... Bitcoin took a huge dive from 60's down to now 40's!
Some people scare themselves out of an opportunity.
Good question. I can only speculate that there are more people vaccinated than not especially for those out there traveling a lot. So the ratio of new infections should reflect the effectiveness of any vaccine against any variant. But on initial look, it might appear as the article points out, that the first offered vaccines are not as effective with this newest variant.
Aside from ZYESAMI... there is BriLife... and perhaps just in time.
Interesting how if you wait on initial news reports.. you learn so much more! This new variant sounds a bit worrisome... except that it appears so far that it may not be as severe.. at least for the healthy.
The difference between the first US "Man Engineered" vaccine and BriLife being studied by NRXP is interesting in that BriLife seems to be manufactured by traditional means and contains all the genetic material so that our bodies can recognize any possible variant. It appears.. so far that the US man-made vaccines are limited in scope with regards to preparing our body's immune system to recognize variants.
From and earlier News Release:
"BriLife presents the entire spike protein complex of the coronavirus to the body's immune system and can simultaneously present multiple variants of the spike protein."
We shall see.
Article:
https://www.reuters.com/world/us/most-reported-us-omicron-cases-have-hit-fully-vaccinated-cdc-2021-12-10/
Most reported U.S. Omicron cases have hit the fully vaccinated -CDC
By Mrinalika Roy
Dec 10 (Reuters) -
Most of the 43 COVID-19 cases caused by the Omicron variant identified in the United States so far were in people who were fully vaccinated, and a third of them had received a booster dose, according to a U.S. report published on Friday.
The U.S. Centers for Disease Control and Prevention (CDC) said that of the 43 cases attributed to Omicron variant, 34 people had been fully vaccinated. Fourteen of them had also received a booster, although five of those cases occurred less than 14 days after the additional shot before full protection kicks in.
While the numbers are very small, they add to growing concerns that current COVID-19 vaccines may offer less protection against the highly transmissible new variant.
The Omicron variant of the coronavirus has been found through testing in about 22 states so far after first being identified in southern Africa and Hong Kong in late November.
Among the Omicron cases, 25 were in people aged 18 to 39 and 14 had traveled internationally. Six people had previously been infected with the coronavirus.
Most of them only had mild symptoms such as coughing, congestion, and fatigue, the report said, and one person was hospitalized for two days. Other symptoms reported less frequently including nausea or vomiting, shortness of breath or difficulty breathing, diarrhea and loss of taste or smell.
The CDC said that while many of the first reported Omicron cases appear to be mild, a lag exists between infection and more severe outcomes. Symptoms would also be expected to be milder in vaccinated persons and those with previous SARS-CoV-2 infection.
The first known U.S. Omicron case was identified on Dec 1 in a fully vaccinated person who had traveled to South Africa. The CDC said that the earliest date of symptom onset was Nov. 15 in a person with a history of international travel.
The Delta variant still accounts for more than 99% of all U.S. cases. But reports from South Africa show that the Omicron variant is very transmissible.
Even if most cases are mild, a highly transmissible variant could result in enough infections to overwhelm health systems, the CDC cautioned.
Laboratory studies released this week suggest that the Omicron variant will blunt the protective power of two doses of Pfizer (PFE.N) and BioNTech's COVID-19 vaccine, although a third dose may restore that protection.
The U.S. has authorized COVID-19 vaccine boosterdoses for all Americans age 16 and older.
Aside from ZYesami... there is BriLife... and perhaps just in time.
Interesting how if you wait on initial news reports.. you learn so much more! This new variant sounds a bit worrisome... except that it appears so far that it may not be as severe.. at least for the healthy.
The difference between the first US "Man Engineered" vaccine and BriLife being studied by NRXP is interesting in that BriLife seems to be manufactured by traditional means and contains all the genetic material so that our bodies can recognize any possible variant. It appears.. so far that the US man-made vaccines are limited in scope with regards to preparing our body's immune system to recognize variants.
We shall see.
Article:
https://www.reuters.com/world/us/most-reported-us-omicron-cases-have-hit-fully-vaccinated-cdc-2021-12-10/
Most reported U.S. Omicron cases have hit the fully vaccinated -CDC
By Mrinalika Roy
Dec 10 (Reuters) -
Most of the 43 COVID-19 cases caused by the Omicron variant identified in the United States so far were in people who were fully vaccinated, and a third of them had received a booster dose, according to a U.S. report published on Friday.
The U.S. Centers for Disease Control and Prevention (CDC) said that of the 43 cases attributed to Omicron variant, 34 people had been fully vaccinated. Fourteen of them had also received a booster, although five of those cases occurred less than 14 days after the additional shot before full protection kicks in.
While the numbers are very small, they add to growing concerns that current COVID-19 vaccines may offer less protection against the highly transmissible new variant.
The Omicron variant of the coronavirus has been found through testing in about 22 states so far after first being identified in southern Africa and Hong Kong in late November.
Among the Omicron cases, 25 were in people aged 18 to 39 and 14 had traveled internationally. Six people had previously been infected with the coronavirus.
Most of them only had mild symptoms such as coughing, congestion, and fatigue, the report said, and one person was hospitalized for two days. Other symptoms reported less frequently including nausea or vomiting, shortness of breath or difficulty breathing, diarrhea and loss of taste or smell.
The CDC said that while many of the first reported Omicron cases appear to be mild, a lag exists between infection and more severe outcomes. Symptoms would also be expected to be milder in vaccinated persons and those with previous SARS-CoV-2 infection.
The first known U.S. Omicron case was identified on Dec 1 in a fully vaccinated person who had traveled to South Africa. The CDC said that the earliest date of symptom onset was Nov. 15 in a person with a history of international travel.
The Delta variant still accounts for more than 99% of all U.S. cases. But reports from South Africa show that the Omicron variant is very transmissible.
Even if most cases are mild, a highly transmissible variant could result in enough infections to overwhelm health systems, the CDC cautioned.
Laboratory studies released this week suggest that the Omicron variant will blunt the protective power of two doses of Pfizer (PFE.N) and BioNTech's COVID-19 vaccine, although a third dose may restore that protection.
The U.S. has authorized COVID-19 vaccine boosterdoses for all Americans age 16 and older.
No... he is actually liable for slander against Dr. Javitt. As I posted in another board, I am surprised that his attempting to influence people through false information in order to manipulate the SP to a lower point is allowed here.
This could be a good thing for 2022...
Over 1,000 BriLife vaccine vials arrive in Georgia for Phase II trial
https://www.jpost.com/health-science/over-1000-israeli-covid-vaccine-vials-land-in-georgia-for-phase-ii-trial-676754
Israel partners with NRx Pharmaceuticals to commercialize COVID vaccine
https://www.reuters.com/world/middle-east/israel-says-signed-mou-with-nrx-pharmaceuticals-covid-vaccine-trials-2021-07-12/
NRx Pharmaceuticals 2021 financial update, Aviptadil Patent, Zyesami, Relief Therapeutics, BriLife August 17 2021