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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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Seeking EUA is just a formality for molnupiravermectin. I'm sure the approval is in the bag.
1 posted on 10/11/2021 8:09:45 AM PDT by American Number 181269513
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To: American Number 181269513

Bet it’s not cheap like some of the other treatments that they don’t want to talk about.


2 posted on 10/11/2021 8:11:29 AM PDT by JaguarXKE (Liberalism is a cancer on our nation.)
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To: All

Kenny Frazier - merck ceo - is an elite scumbag. Just sayin’...


3 posted on 10/11/2021 8:17:23 AM PDT by FLNittany
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To: JaguarXKE

JaguarXKE wrote: “Bet it’s not cheap like some of the other treatments that they don’t want to talk about.”

Perhaps but this treatment has been subjected to peer reviewed studies proving that it works, unlike those ‘other treatments’ often touted here.


4 posted on 10/11/2021 8:21:21 AM PDT by DugwayDuke (Most pick the expert who says the things they agree with.)
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To: DugwayDuke

For how long has this treatment undergone “studies?”


5 posted on 10/11/2021 8:22:36 AM PDT by goodnesswins (The issue is never the issue. The issue is always the revolyution." -- Saul Alinksy)
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To: American Number 181269513

Molnupiravir ©

Take the Red Pill ©

Active Ingredients

Disclaimer for the dim people: this is sarcasm. The above dosages have a better track record than Molnupiravir's 50%

6 posted on 10/11/2021 8:23:40 AM PDT by Pollard (PureBlood)
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To: American Number 181269513
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.

Once again, no long-term safety study. Isn't this drug a mutagen, with significant risk of being carcinogenic?

7 posted on 10/11/2021 8:26:40 AM PDT by MortMan (1984 was not meant to be a recipe book.)
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To: goodnesswins

https://www.clinicaltrials.gov/ct2/show/NCT04575584

Clinical Trial Phases 2/3 started Oct 2020 and ended Aug 2021

Phase 4 will be done on the general population via EUA because that’s the way clinical trials work now.


8 posted on 10/11/2021 8:27:37 AM PDT by Pollard (PureBlood)
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To: DugwayDuke

And why do you suppose those others have not undergone “peer review?” Follow the money.


9 posted on 10/11/2021 8:29:16 AM PDT by JaguarXKE (Liberalism is a cancer on our nation.)
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To: Pollard

Yeah...figures


10 posted on 10/11/2021 8:37:02 AM PDT by goodnesswins (The issue is never the issue. The issue is always the revolyution." -- Saul Alinksy)
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To: JaguarXKE

Actually I believe ivermectin has undertone peer reviewed study

Latest peer-reviewed research: Immediate global ivermectin use will end COVID-19 pandemic

https://clinicalnews.org/2021/05/07/latest-peer-reviewed-research-immediate-global-ivermectin-use-will-end-covid-19-pandemic/amp/


11 posted on 10/11/2021 8:38:20 AM PDT by Bob434
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To: DugwayDuke

Did you miss the part that said “ stopped at the interim”? Doesn’t exactly fill one with confidence when they say that things were so good halfway we didn’t need to do the second half. It’ll be fine. /s


12 posted on 10/11/2021 8:38:42 AM PDT by 1malumprohibitum
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To: Bob434

Yeah but that doesn’t count unless Fauci says so </sarc>


13 posted on 10/11/2021 8:42:16 AM PDT by JaguarXKE (Liberalism is a cancer on our nation.)
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To: Bob434

Since ivermectin and monoclonal antibodies work- will an EUA of this less effective and more expensive treatment again prohibit use of other more effective treatments? That seems to be the situation with the “vaccines” .


14 posted on 10/11/2021 8:42:57 AM PDT by TeddyRay ( I am a Chump 4 Trump)
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To: MortMan

So is sunlight. But hey. Let’s not move forward with a drug that the study was stopped because the results were so favorable. Anyone who knows anything about science and a prospective randomized study knows that if the IRB independently stops it for results that is a BFD.

I am amazed that we continue on this board to demand unproven (just ask Allen West how well ivermectin did for him) treatments and disparage targeted therapies.


15 posted on 10/11/2021 8:47:27 AM PDT by gas_dr (Conditions of Socratic debate: Intelligence, Candor, and Good Will. )
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To: 1malumprohibitum

You obviously do not understand what it means when an IRB stops a study at an interim point. What it means is the results are so overwhelming that ethically it demands either terminating the study of negative or moving it forward if positive.

Again here we have a lack of foundation as to the process coupled with an assumption that frankly demonstrates your lack of understanding.


16 posted on 10/11/2021 8:50:27 AM PDT by gas_dr (Conditions of Socratic debate: Intelligence, Candor, and Good Will. )
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To: DugwayDuke

It’s been tested and proven to work on well over 400 million people, just peer review by US doctors hasn’t happened and WONT happen! USA, the only country where HCQ and Ivermectin don’t work, and YOU believe that


17 posted on 10/11/2021 8:50:50 AM PDT by gbs
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To: Bob434

Finally, ivermectin is peer reviewed

“In the May-June 2021 edition (Volume 28 Issue3) of the prestigious American Journal of Therapeutics, a collaborative paper on the drug, entitled “Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19” authored by a group of doctors and scientists led by Dr. Pierre Kory and Dr. Paul Marik, was finally given space”

” Evidence has now emerged that indeed ivermectin has exhibited numerous antiviral and anti-inflammatory mechanisms with trial results reporting significant outcome benefits. As the paper noted, a large majority of randomized and observational controlled trials of ivermectin “are reporting repeated, large magnitude improvements in clinical outcomes”

https://manilastandard.net/mobile/article/353574


18 posted on 10/11/2021 8:51:22 AM PDT by Bob434
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To: Bob434
That looks nice, but who the heck is "clinicalnews.org?" Well, if you look them up, that Domain is registered by "Vitamin and Herb Stores" out of California. Ergo, not sure how much weight their Peer review carries. Just sayin.

Who is clinicalnews.org

19 posted on 10/11/2021 8:51:38 AM PDT by JaguarXKE (Liberalism is a cancer on our nation.)
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To: gas_dr

You should know better than to use anecdotal evidence to support your bias. There are people for whom conventional medicine for covid is not working too. Buy hey, let’s dance to the misfortune of others huh?


20 posted on 10/11/2021 8:55:00 AM PDT by Bob434
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