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Merck seeks FDA emergency use authorization for antiviral Covid-19 treatment molnupiravir
CNN ^ | October 11, 2021 | Jamie Gumbrecht and Maggie Fox

Posted on 10/11/2021 8:09:45 AM PDT by American Number 181269513

Merck said Monday it is seeking US Food and Drug Administration emergency use authorization for its experimental antiviral Covid-19 treatment, molnupiravir.

If authorization is granted, the drug, made by Merck and Ridgeback Biotherapeutics, would be the first oral antiviral treatment to fight Covid-19. It comes in capsule form.

Merck said it is asking for authorization for the capsules to treat infected adults who are at risk of progressing to severe Covid-19 disease or hospitalization. Its submission is based on a study that was stopped at the interim point because the drug was working so well in more than 700 patients randomly assigned to take either molnupiravir or a placebo.

"At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of placebo-treated patients," the company said in a statement.

"Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received placebo." None of the volunteers in the trial had been vaccinated.

(Excerpt) Read more at cnn.com ...


TOPICS: Business/Economy; News/Current Events
KEYWORDS: chinavirustreatment; covid19; emergencyuse; fda; ivermectin; merck; molnupiravir
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To: JaguarXKE

What has their website got to do with the fact that the evidence was peer reviewed by doctors?


21 posted on 10/11/2021 8:56:03 AM PDT by Bob434
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********


22 posted on 10/11/2021 9:00:03 AM PDT by PMAS (Vote with your wallets, there are 80 million of us - No China made, No Amazon)
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To: Bob434

Basic credibility. My opinion. Fine if you disagree. If it was published in New England Journal of medicine I’d be more impressed.


23 posted on 10/11/2021 9:00:21 AM PDT by JaguarXKE (Liberalism is a cancer on our nation.)
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To: JaguarXKE

WASHINGTON, D.C. – Peer reviewed by medical experts that included three U.S. government senior scientists and published in the American Journal of Therapeutics, the research is the most comprehensive review of the available data taken from clinical, in vitro, animal, and real-world studies. Led by the Front Line COVID-19 Critical Care Alliance (FLCCC), a group of medical and scientific experts reviewed published peer-reviewed studies, manuscripts, expert meta-analyses, and epidemiological analyses of regions with ivermectin distribution efforts all showing that ivermectin is an effective prophylaxis and treatment for COVID-19.


24 posted on 10/11/2021 9:00:36 AM PDT by Bob434
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To: Bob434

Hardly dancing to any misfortune. Yet there is no intellectual honesty in the ivermectin proponents behalf as they breathlessly report every sore arm from vaccination as earth shattering but refuse to see what is far more common. The failure of ivermectin. The same thing we have seen over and over again that it is not an absolute treatment nor prophylaxis.


25 posted on 10/11/2021 9:02:52 AM PDT by gas_dr (Conditions of Socratic debate: Intelligence, Candor, and Good Will. )
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To: 1malumprohibitum
Actually, stopped at interim is characteristic of trials where the folks getting placebo were very adversely effected, so the trial stopped exposing placebo patients to the viral effects unprotected.

I am persuaded that this 'new drug' is a combo of Ivermectin (with the initial molecule altered ever so slightly) and one or two other proven virus fighters.

26 posted on 10/11/2021 9:02:54 AM PDT by MHGinTN (A dispensation perspective is a powerful tool for discernment)
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To: American Number 181269513

Meanwhile they are stalling Novavax’s approval for it’s conventional vaccine.


27 posted on 10/11/2021 9:07:59 AM PDT by IDFbunny (Fat shaming works.)
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To: Bob434

I read it. My opinion is unchanged. I’d like to see this in some other mainstream journals, that’s all I’m saying.


28 posted on 10/11/2021 9:14:10 AM PDT by JaguarXKE (Liberalism is a cancer on our nation.)
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To: IDFbunny
Meanwhile they are stalling Novavax’s approval for it’s conventional vaccine.

While it isn't an mRNA vaccine, the Novavax platform is by no means "conventional."

29 posted on 10/11/2021 9:22:33 AM PDT by DSH
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To: gas_dr

Has this targeted therapy ever been approved before? Is there a long-term safety profile at all?

I did not speak to its efficacy, which is apparently impressive. I spoke to safety.

Your making a strawman out of efficacy doesn’t change the truth of what I said.


30 posted on 10/11/2021 9:31:07 AM PDT by MortMan (1984 was not meant to be a recipe book.)
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To: goodnesswins

Bttt


31 posted on 10/11/2021 9:40:56 AM PDT by Guenevere (When the foundations are being destroyed what can the righteous do t)
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To: American Number 181269513

Ivermercktin?


32 posted on 10/11/2021 9:43:21 AM PDT by Hegemony Cricket (< < Wandering aimfully > >)
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To: DugwayDuke
Perhaps but this treatment has been subjected to peer reviewed studies proving that it works, unlike those ‘other treatments’

What a stupid, sarcastic comment. Why have the others not been subjected to peer reviewed studies? They have a track record of working and I can personally attest to cases they have cured. But you go on drinking the koolaid they piss in your face.
33 posted on 10/11/2021 10:08:20 AM PDT by JoSixChip (2020: The year of unreported truths. )
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To: American Number 181269513

Using ivermectin in there as well.


34 posted on 10/11/2021 10:10:03 AM PDT by SkyDancer (If at first you don't succeed, so much for skydiving)
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To: Pollard

I’d love for your graphic to be true, but I cannot find any substantiation of this in my searches. Can you please tell us where you got this ingredient info? Thanks.


35 posted on 10/11/2021 10:13:01 AM PDT by reformedcrat
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To: MortMan
"Once again, no long-term safety study. Isn't this drug a mutagen, with significant risk of being carcinogenic?"

An article published in The Journal of Infectious Diseases (Volume 224, Issue 3, 1 August 2021) linked below presents some results that certainly indicate the unintended consequences of the drug require further investigation. For clarification of the article's title, β-D-N4-hydroxycytidine (NHC) is the initial metabolite of Molnupiravir (Merck's experimental early treatment drug for COVID-19). The bolded text in the abstract is my doing.

β-D-N4-hydroxycytidine Inhibits SARS-CoV-2 Through Lethal Mutagenesis But Is Also Mutagenic To Mammalian Cells

Abstract

Mutagenic ribonucleosides can act as broad-based antiviral agents. They are metabolized to the active ribonucleoside triphosphate form and concentrate in genomes of RNA viruses during viral replication. β-D-N4-hydroxycytidine (NHC, initial metabolite of molnupiravir) is >100-fold more active than ribavirin or favipiravir against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), with antiviral activity correlated to the level of mutagenesis in virion RNA. However, NHC also displays host mutational activity in an animal cell culture assay, consistent with RNA and DNA precursors sharing a common intermediate of a ribonucleoside diphosphate. These results indicate highly active mutagenic ribonucleosides may hold risk for the host.

Will we witness another product rushed to market that employs a genetic approach for COVID-19 without first thoroughly investigating the safety of the product? Hmmm...where have we heard this story before?
36 posted on 10/11/2021 10:17:25 AM PDT by Unmarked Package
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To: American Number 181269513

Worthy of note:

https://freerepublic.com/focus/f-bloggers/4002434/posts

One Month After Biden Announced Federal Vaccine Mandate, It Still Has Not Been Formally Issued
Trending Politics ^ | October 10, 202 | Kyle Becker

Posted on 10/10/2021, 3:38:07 PM by Norski

One month after the Biden administration announced a draconian federal vaccine mandate that impacted an estimated 100 million Americans and led to mass firings of public servants, teachers, and medical workers, the federal regulation still has not been formally issued.

The Federalist reported . . in a post on Thursday that noted, “Joe Biden’s Vaccine Mandate Doesn’t Exist. It’s Just A Press Release”:

Biden’s so-called vaccine mandate doesn’t exist — at least, not yet. So far, all we have is his press conference. No such rule even claiming to be legally binding has been issued yet.

That’s why nearly two dozen Republican attorneys general who have publicly voiced their opposition to the clearly unconstitutional and illegal mandate haven’t yet filed suit against it, the Office of the Indiana Attorney General confirmed for me. There is no mandate to haul into court. And that may be part of the plan.

According to several sources, so far it appears no such mandate has been sent to the White House’s Office of Information and Regulatory Affairs yet for approval. The White House, the Occupational Safety and Health Administration (OSHA), and the Department of Labor haven’t released any official guidance for the alleged mandate. There is no executive order. There’s nothing but press statements.

Despite what you may have been . . . led to believe by the media, . . . press statements have exactly zero legal authority.

“There is nothing there yet that gives employers any mandate,” Stephanie McFarland, spokeswoman for the Indiana Occupational Safety and Health Administration, told The Federalist’s Joy Pullman on Oct. 6. “The president made an announcement on this asking OSHA to do it, but we’ve not yet seen anything come from it yet,”. When the state agency gets any further information, she said, they’ll review it.”

(Excerpt) Read more at trendingpolitics.com ...


37 posted on 10/11/2021 10:22:20 AM PDT by Norski (Tolerance becomes a crime when applied to evil. - Thomas Mann)
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To: reformedcrat
Did you not see the sarcasm disclaimer?

The (fake)ingredient info is actually drugs from the FLCCC/Zelenko covid treatment protocols.

https://vladimirzelenkomd.com/wp-content/uploads/2021/08/Treatment_Protocol.pdf

The 18mg Ivermectin I used on my fake Molnupiravir ingredient list would be for a 160-200 lb person.

https://en.wikipedia.org/wiki/Molnupiravir gives some indication of what Molnupiravir is but is gibberish to me.

38 posted on 10/11/2021 10:33:14 AM PDT by Pollard (PureBlood)
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To: Pollard

Costs almost nothing to make and will charge how much $1000 per pill ,D’oh


39 posted on 10/11/2021 10:36:07 AM PDT by butlerweave
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To: American Number 181269513
If authorization is granted, the drug, made by Merck and Ridgeback Biotherapeutics, would be the first oral antiviral treatment to fight Covid-19. It comes in capsule form.

Uh CNN... hello... interesting how you left out Ivermectin and HCQ.

Report (10/11/21) on 63 trials showing Ivermectin IS effective against the CCP virus.

There are literally thousands of folks in India who have been saved by Ivermectin.

I know you don't like people pointing out this indisputable truth. Tough, there it is.

40 posted on 10/11/2021 10:40:50 AM PDT by upchuck (The longer I remain unjabbed, the more evidence I see supporting my decision. Psalm 144:5-8)
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