EIDD-2801, as Covid-19 therapy raises more questions than it answers...from a safety profile, specifically toxicity and mutation causing attributes!
Right from one of the articles you posted...
1. An Emory University program (Drive)developed the drug (George Painter)...who is now a "consultant" to Ridgeback
2. They could not give EIDD-2801 away, until Holman as a consultant to his Wife... the single owner of Ridgeback funded the purchase of patents from Emory.
3. "According to Bright’s account, when he told the group his reservations, Painter “insisted that EIDD-2801 could be a great asset to American national security and warned that if BARDA did not fund its manufacturing immediately, Emory would take the drug to another country to manufacture it.” " INTERESTING LEVERAGING OF FOREIGN COUNTRY INTEREST!...Hello Russia?
4. FLY IN THE OINTMENT!... IS ANYONE INTERESTED IN GROWING ANOTHER ARM? EIDD-2801... has high toxicity and highly mutagenicity
"Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, notes that his former pharmaceutical company, Pharmasset, abandoned it in 2003 after discovering its mutagenic properties. Schinazi says the small chemical tweaks made to increase the ingredient’s bioavailability and transform it into EIDD-2801 are unlikely to change its mutagenicity. “Thank goodness someone is raising the red flag,” about EIDD-2801, Schinazi says. “You don’t develop a drug that’s mutagenic. Period.”
5. NOTHING TO SEE HERE!" ???
"Toxicity studies with EIDD-2801 have taken place in mice, rats, dogs, and nonhuman primates" (...TEETH MISSING, SKULLS PARTIALLY FORMED...)"Painter says, and the results have been shared with FDA and drug regulators in Europe."
6. How much credence will be given to this drug with FDA "EUA"..." it's safe"? How much MUTATION tolerance is the POTENTIAL RECIPIENTS of these drugs willing to take?...
"Denison, who is also a clinician, notes that some mutagenic drugs have come to market—and that weighing their risks versus their benefits depends on the dose, frequency of use, and the severity of the disease. (THAT'S COMFORTING!) Ribavirin, for example, has been used to treat hepatitis C, Lassa fever, and other viral diseases despite mutagenic properties severe enough that regulators advise women who are pregnant or considering pregnancy, or men whose partners are considering a baby, to not take it. For EIDD-2801 as a treatment of COVID-19, Denison says, “We’re talking about a short-term use to potentially treat or prevent disease.” Schinazi counters that reproductive harm could still happen with short-term treatment, and using the drug to prevent disease—a hoped-for use of other experimental COVID-19 drugs—might lead to far more exposure."
BOTTOM LINE... it is comical and sad that those who allege "expertise" still deny the toxicity of the "Spike Protein" from the mRNA vaccines...and SAE not formally recorded for Remdesivir. (liver toxicity)
IMO...ITS ALL ABOUT "Uninformed Consent"...NOT INFORMED CONSENT! EUA not = SAFE, it is "We (FDA/CDC) have decided that some Recipients can take bodily damage or death...to be politically expedited...and appear as though we have this pandemic under control"...SO WE LIE.
Standard: “We’re talking about a short-term use (with damage or death to some) to potentially treat or prevent disease.”
"In November 2019, the whistleblower complaint says, Bright met with Emory University chemist George Painter, who is the CEO of Drug Innovation Ventures at Emory (DRIVE), a nonprofit owned by the university that is developing EIDD-2801. Painter brought a consultant with him, John Clerici, a lawyer. Clerici formerly worked as a registered lobbyist for Chimerix, a company previously led by Painter that received $72 million from BARDA to develop a smallpox drug. A biography posted by Clerici’s current law firm says he specializes in biodefense and “has assisted more than three dozen companies in obtaining over four billion dollars in funding for the research, development, and procurement of public health countermeasures.” Bright’s complaint describes Painter as a “longtime friend of” Kadlec’s and says Clerici had “a long-standing connection to” him.
According to the complaint, Painter and Clerici presented EIDD-2801 (EIDD stands for Emory Institute for Drug Development) as a viral “cure-all” and “miracle cure.” Bright, concerned that evaluation of its safety in people had not yet been done, says he pushed back against pressure from Painter, Clerici, and Kadlec to fund EIDD’s development for an unspecified amount. He says he was also reluctant because Emory had already received a total of $26 million from NIH and the Department of Defense to advance the drug. Bright’s complaint says he believed BARDA should wait to see some results from a human safety trial “to make an informed decision based on scientific data.”
According to Bright’s account, when he told the group his reservations, Painter “insisted that EIDD-2801 could be a great asset to American national security and warned that if BARDA did not fund its manufacturing immediately, Emory would take the drug to another country to manufacture it.” Despite Bright’s concerns, according to the complaint, late last year Kadlec “made it clear that he intended to push the funding through for this contract.”
Painter says the November meeting with BARDA was arranged through “normal channels” and was for “just a little bit of money” to help develop a protocol to submit to regulators to conduct human studies. He also says he never referred to EIDD-2801 as a cure-all or miracle cure and he is “rather taken aback” by Bright’s complaint. “I just feel like collateral damage in a battle,” says Painter, who adds that he has known Kadlec for years but doesn’t consider him a friend. Clerici calls Bright’s complaints “politically motivated allegations,” adding “I unequivocally deny the reckless insinuations in Dr. Bright’s complaint.”
In late 2019, according to the complaint, Kadlec called a meeting to discuss the request for EIDD-2801 funding, and Bright reiterated his reservations. “Dr. Kadlec let it be known he was very unhappy with Dr. Bright’s position on this issue,” it stated.
Two months later, Painter and Clerici contacted the head of ASPR Next—which the complaint describes as an “opaque funding program” separate from BARDA—for EIDD-2801 funding. They now billed the broad-spectrum antiviral as a possible COVID-19 treatment. Bright by then had set up a task force to speed BARDA funding requests for the rapidly spreading disease. “Dr. Painter and Mr. Clerici were deliberately circumventing the [task force] submissions process,” the complaint asserts.
Painter categorically denies this allegation. “I don’t know what [Bright’s] referring to,” he says. “I don’t have a dog in this fight. I just wish that things were better controlled under the circumstances where there are a lot of people dying.”
In March, a study published on the preprint server bioRxiv showed that EIDD-2801 could cripple SARS-CoV-2, the RNA virus that causes COVID-19, in human cells. “It was profoundly active against the virus,” says Mark Denison, a virologist at Vanderbilt University Medical Center who co-authored the study. (It was published on 29 April in Science Translational Medicine.)
Also in March, DRIVE found a new partner in Ridgeback, a small, privately held company founded by husband and wife Wayne Holman and Wendy Commins Holman, that is best known to infectious disease scientists for licensing an experimental monoclonal antibody that worked well against the Ebola virus in a clinical trial. (That treatment was developed by the National Institute of Allergy and Infectious Diseases.) Ridgeback purchased an exclusive license to EIDD-2801 from DRIVE for an undisclosed amount.
Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, notes that his former pharmaceutical company, Pharmasset, abandoned it in 2003 after discovering its mutagenic properties. Schinazi says the small chemical tweaks made to increase the ingredient’s bioavailability and transform it into EIDD-2801 are unlikely to change its mutagenicity. “Thank goodness someone is raising the red flag,” about EIDD-2801, Schinazi says. “You don’t develop a drug that’s mutagenic. Period.”
Toxicity studies with EIDD-2801 have taken place in mice, rats, dogs, and nonhuman primates, Painter says, and the results have been shared with FDA and drug regulators in Europe. “We haven’t seen robust evidence for any sort of mutagenicity as had been seen in the past [by Schinazi and others],” Painter says, noting that regulators gave them approval to conduct phase I studies of the drug in healthy humans. DRIVE and Ridgeback, which is sponsoring the clinical trials, plan to do “more rigorous analyses,” including reproductive studies in animals, Painter says. “We’ve been very, very, very thorough.”
Denison, who is also a clinician, notes that some mutagenic drugs have come to market—and that weighing their risks versus their benefits depends on dose, frequency of use, and the severity of the disease. Ribavirin, for example, has been used to treat hepatitis C, Lassa fever, and other viral diseases despite mutagenic properties severe enough that regulators advise women who are pregnant or considering pregnancy, or men whose partners are considering a baby, to not take it. For EIDD-2801 as a treatment of COVID-19, Denison says, “We’re talking about a short-term use to potentially treat or prevent disease.” Schinazi counters that reproductive harm could still happen with short-term treatment, and using the drug to prevent disease—a hoped-for use of other experimental COVID-19 drugs—might lead to far more exposure."
Molunpiravir's safety concerns still have not been satisfactorily addressed in spite of the fact it is Ames positive. Dr Bright had serious concerns regarding molunpiravir being mutagenic and the political pressure being placed to approve the drug.
Mr Perlmutter's comments below are less than reassuring
" Merck’s Research Labs President Roger Perlmutter addressed the lingering questions about the drug’s mutagenic side-effects during the earnings call and explained what the company is doing to address safety concerns, a transcript of which is available at this link.
First of all, for the MK-4482, as you know, the compound is Ames positive. That’s, in a way, not unexpected given its mechanism of action. It is a cytosine analog so that — one could expect to see those kinds of things. The question is, does the compound have mutagenic activity that’s meaningful in mammalian cells and what do we want to do about this. Ordinarily, of course, we don’t want to take mutagens forward into clinical practice, although it has been done where the benefit/risk profile makes sense"
Below is a copy of my post 351726 from 3/11/2021which highlights some of the points made in the above article
Controversy regarding Molnupiravir formerly EIDD-2801 now MK-4482 continues:
"This brings us to the controversy around the drug as explained by C&EN (emphasis ours):
" EIDD-2801 has been viewed as a potential competitor to remdesivir, although a contentious one, because similar compounds are mutagenic in animal studies, meaning they produce birth defects. Rick Bright, who was removed from his position as head of the US Biomedical Advanced Research and Development Authority (BARDA) in April, was reluctant to provide funding for the drug for this reason, according to an 89-page whistleblower complaint Bright filed after being fired. Merck’s investment in EIDD-2801 can be seen as a vote of confidence in the compound.
Bright’s concerns began in November 2019, more than one month before China disclosed the first COVID-19 cases in Wuhan — ScienceMag has that story:
Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, notes that his former pharmaceutical company, Pharmasset, abandoned it in 2003 after discovering its mutagenic properties. Schinazi says the small chemical tweaks made to increase the ingredient’s bioavailability and transform it into EIDD-2801 are unlikely to change its mutagenicity. “Thank goodness someone is raising the red flag,” about EIDD-2801, Schinazi says. “You don’t develop a drug that’s mutagenic. Period.”
" Merck’s Research Labs President Roger Perlmutter addressed the lingering questions about the drug’s mutagenic side-effects during the earnings call and explained what the company is doing to address safety concerns, a transcript of which is available at this link.
First of all, for the MK-4482, as you know, the compound is Ames positive. That’s, in a way, not unexpected given its mechanism of action. It is a cytosine analog so that — one could expect to see those kinds of things. The question is, does the compound have mutagenic activity that’s meaningful in mammalian cells and what do we want to do about this. Ordinarily, of course, we don’t want to take mutagens forward into clinical practice, although it has been done where the benefit/risk profile makes sense"
What does it mean to be Ames positive?:
The Ames test is a widely employed method... it is a biological assay to assess the mutagenic potential of chemical compounds.[1] A positive test indicates that the chemical is mutagenic and therefore may act as a carcinogen, because cancer is often linked to mutation. The test serves as a quick and convenient assay to estimate the carcinogenic potential of a compound...
THe positive Ames test and documented birth defects in similar compounds as document by Dr Bright must be thoroughly addressed.
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