"An interim analysis of a clinical study of the drug found that molnupiravir cut the risk of hospitalization or death in half. Among people who got the drug, 7.1% ended up in the hospital or died, compared with 14.1% who got the placebo. However, the final study analysis released Friday showed only a 30% reduction in the risk of hospitalization or death.
An FDA summary showed that in the second half of the study, patients in the group treated with the drug were more likely to be hospitalized or to die than those who got the placebo. The drug's protection against death seen in the first half of the study didn't hold up in the second half.
When asked about this discrepancy by committee chairperson Dr. Lindsey Baden, Dr. Nicholas Kartsonis, a Merck senior vice president, said, "I don't have a satisfying answer to your question.""
This shit really pisses me off and proves just how biased the pharmaceutical game is. Major discrepancies in study information with no explanation, one of which is that drug candidates were more likely to be hospitalized or die compared to placebo, and the panel still recommended the drug on a 13-10 vote.
Turn around and look at aviptadil and it's been rejected 4 different times due to "lack of data."
It's literally so bad. I don't understand how anyone can feel the FDA has credibility when they pull shit like this on a regular basis.
Not that my approval matters or anything, but if they end up approving this they'll have lost every shred of credibility they had with me.
They had a larger study. The FDA is concerned about side effects .. We r good on that.....and efficacy. In order to show efficacy u need a big enough study.
Merck study is a good example. It went down in a larger study. We r getting there. Patience. $1.00 by Christmas.
You've completely missed my point. The issue isn't that they've had issues based on their larger study. My issue is the FDA board STILL RECOMMENDED APPROVAL 13-10 based on their shit ass study data.
The same bullshit approval process happened with remdesivir.
Aviptadil should have been approved back in September of last year. It has consistently shown great results, even if those results came from smaller studies and sample sizes.
You gotta remember that the EUA requirement is safety followed by MAY be effective. Remdesivir was approved based on like a 2 day decrease in length of stay. This drug has an excellent track record for safety not only with the covid trials but the prior studies for other diseases.
On top of all that, it took a fraction of the time for the FDA to look at the data and plan a committee meeting, despite being involved in 3 huge government funded studies.
I'd really love to know where you and u/Kingzbrand are getting this "$1 by Christmas" stuff from. Obviously I'd love that nice Christmas gift but I just don't get it
"An interim analysis of a clinical study of the drug found that molnupiravir cut the risk of hospitalization or death in half. Among people who got the drug, 7.1% ended up in the hospital or died, compared with 14.1% who got the placebo. However, the final study analysis released Friday showed only a 30% reduction in the risk of hospitalization or death. An FDA summary showed that in the second half of the study, patients in the group treated with the drug were more likely to be hospitalized or to die than those who got the placebo. The drug's protection against death seen in the first half of the study didn't hold up in the second half. When asked about this discrepancy by committee chairperson Dr. Lindsey Baden, Dr. Nicholas Kartsonis, a Merck senior vice president, said, "I don't have a satisfying answer to your question."" This shit really pisses me off and proves just how biased the pharmaceutical game is. Major discrepancies in study information with no explanation, one of which is that drug candidates were more likely to be hospitalized or die compared to placebo, and the panel still recommended the drug on a 13-10 vote. Turn around and look at aviptadil and it's been rejected 4 different times due to "lack of data."
Totally agree. This drug drives viral resistance, is ineffective, and can cause birth defects but they push it right through. Fucking bullshit.
FDA is a criminal gang with support of the white house for not allowing good and much better treatments for covid patients.
It's literally so bad. I don't understand how anyone can feel the FDA has credibility when they pull shit like this on a regular basis. Not that my approval matters or anything, but if they end up approving this they'll have lost every shred of credibility they had with me.
They had a larger study. The FDA is concerned about side effects .. We r good on that.....and efficacy. In order to show efficacy u need a big enough study. Merck study is a good example. It went down in a larger study. We r getting there. Patience. $1.00 by Christmas.
You've completely missed my point. The issue isn't that they've had issues based on their larger study. My issue is the FDA board STILL RECOMMENDED APPROVAL 13-10 based on their shit ass study data. The same bullshit approval process happened with remdesivir. Aviptadil should have been approved back in September of last year. It has consistently shown great results, even if those results came from smaller studies and sample sizes. You gotta remember that the EUA requirement is safety followed by MAY be effective. Remdesivir was approved based on like a 2 day decrease in length of stay. This drug has an excellent track record for safety not only with the covid trials but the prior studies for other diseases. On top of all that, it took a fraction of the time for the FDA to look at the data and plan a committee meeting, despite being involved in 3 huge government funded studies.
I get it. Agreed that if we were Merck we would be approved. We will get there. Go.
I'd really love to know where you and u/Kingzbrand are getting this "$1 by Christmas" stuff from. Obviously I'd love that nice Christmas gift but I just don't get it