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FDA advisers vote to recommend emergency use authorization of Merck's pill to treat Covid-19
Re: Observed fall-off in Molnupiravir efficacy
From #msg-166912284 (posted last week):
Merck's COVID-19 pill significantly less effective in new analysis
Nov 26 (Reuters) - Merck & Co said on Friday updated data from its study of its experimental COVID-19 pill showed the drug was significantly less effective in cutting hospitalizations and deaths than previously reported.
The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from 1,433 patients. In October, its data nL1N2QX0QJ showed a roughly 50% efficacy, based on data from 775 patients. The drug, molnupiravir, was developed with partner Ridgeback Biotherapeutics.
The lower efficacy of Merck's drug could have big implications in terms of whether countries continue to buy the pill. Interim data from 1,200 participants in Pfizer Inc's trial for its experimental pill, Paxlovid, showed an 89% reduction in hopsitalizations and deaths.
Merck's shares fell 3.5% to $79.39 in morning trading.
Merck released the data before the U.S Food and Drug Administration published a set of documents on Friday intended to brief a panel of outside experts who will meet on Tuesday to discuss whether to recommend authorizing the pill.
The agency's staff did not make their own recommendation as to whether the pill should be authorized.
FDA staff asked the panel to discuss whether the benefits of the drug outweigh the risks and whether the population for whom the drug should be authorized should be limited.
They also asked the committee to weigh in on concerns over whether the drug could encourage the virus to mutate, and how those concerns could be mitigated.
Pills like molnupiravir and Paxlovid could be promising new weapons in the fight against the pandemic, as they can be taken as early at-home treatments to help prevent COVID-19 hospitalizations and deaths. They could also become important tools in countries and areas with limited access to vaccines or low inoculation rates.
EASIER TREATMENT
The Merck and Pfizer pills are cheaper to produce and easier to administer than existing treatment options such as antibody therapies from Regeneron and Eli Lilly, which are mostly administered as intravenous infusions.
The two experimental drugs have different mechanisms of action. Merck's is designed to introduce errors into the genetic code of the virus. Pfizer's drug, part of a class known as protease inhibitors, is designed to block an enzyme the coronavirus needs in order to multiply.
Merck filed for a U.S. authorization of molnupiravir on Oct. 11, following the interim data, and submitted the updated data to the FDA this week.
The molnupiravir arm of the study had a hospitalization and death rate of 6.8%, according to the updated data. The placebo group had a hospitalization and death rate of 9.7%.
One patient in the molnupiravir arm died, versus nine in the placebo group.
The United Kingdom conditionally approved molnupiravir, branded as Lagevrio, earlier this month.
Merck expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022. It has a contract with the U.S. government to supply as many as 5 million courses at a price of $700 per course. Several other countries have already secured millions of courses of the pill.
Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age also had to use birth control.
Still, the FDA said in its briefing document that there are safety concerns about potential birth defects from the drug and asked the panel to discuss whether the drug should be available to pregnant women.
FDA approves Keytruda monotherapy in adjuvant RCC:
https://finance.yahoo.com/news/fda-approves-merck-keytruda-pembrolizumab-114500052.html
Guilt by association!
FDA to meet with MRK for its COVID antiviral pill, on 11-30-21 --
The committee will discuss Emergency Use Authorization (EUA) 000108, submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules for treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.
https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-30-2021-antimicrobial-drugs-advisory-committee-meeting-announcement-11302021-11302021
AS I SAID BEFORE "Cancer causing Molnupiravir is a FLOP, Merck should pull this toxic poison from the market immediately before too much damage is done. Massive class action lawsuits are coming Merck's way if they don't."
SHAME ON MERCK FOR PUSHING THIS DANGEROUS DRUG ON THE UNSUSPECTING PUBLIC!!!!
MRK IS GOING LOWER.... A LOT LOWER!!!!
SELL BEFORE ITS TOO LATE!!!!
Was there news that caused that drop?
I had a TON of puts that would have expired worthless today!
Largest % gain of the year for me!
Awaiting the SEC's letter asking me to explain my trade...
I bailed @ 89 but hope to grab again some day. :)
TIMMMMMBBBBBBEEEEEERRRRRRR!!!!!!!!
<THUD>
Thanks for the tip.
Sure... who cares about cancers... THERE IS MONEY TO BE MADE!
Huge uptrend this week going into earnings….. they have a lot working for them and with another variant, the pill will get fast tracked
It's going to be tough for MRK to garner much market share in this market (#msg-166441220).
CDC's Advisory Committee Backs Pneumococcal Vaccine From Pfizer, Merck
ACIP endorses PFE’s Prevnar-20 for_adults_65+_or_19+_ with_medical_conditions:
https://www.businesswire.com/news/home/20211020006069/en
ACIP also endorsed MRK’s V114 for the same patient pool—but only if followed by Pneumovax. Requiring only one shot—and having broader serotype coverage—is a clear marketing edge for PFE in what will be a very large market.
Because it moved up on fake news! Of course it is headed back down!
DOW UP OVER 500 POINTS AND MRK IS ***RED***!!!!!!!!
Make sure to take your VIX with your Ivermectin!
So a few kids will be born without teeth and without parts of their skulls... is that a problem if Merck can make money?
Cancer causing Molnupiravir is a FLOP, Merck should pull this toxic poison from the market immediately before too much damage is done. Massive class action lawsuits are coming Merck's way if they don't.
Exactly correct!
Anyone who is dumb enough to take this shit will find themselves staring in the mirror in a few years after getting a cancer diagnosis asking themselves "What was I thinking"?
It isn't even like this is a theory... it WILL happen to many people!
It is different... much different!
During the height of the "pandemic", with no known medications available, they decided to give the current vaxes an EUA and take a gamble.
There is no reason to take the same gamble on this cancer tablet!
Cancers take years to grow...
This pill will cause cancers... it prevents your immune system from removing cancer cells before they can cause a problem!
The immune system kills spontaneous blood cancer cells every day!
MRK under heavy accumulation since last week -- eyes on the prize.
Long term data? Yeah the covid vaccines had tons of long term data...not
MRK is trading up on misinformation!
The pill data is being spun... the FDA isn't that stupid!
The risks are long term (cancer), and without long term data, it cannot be approved. There are equally effective drugs that have a proven safety profile.
$MRK high estimate of 107.00
Microwave ovens are safe... phones are not.
People need their phones, they don't need the Merck poison!
Microwaves and phones cause cancer too. I dont see the use of those going down.
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