Replies to post #240461 on Biotech Values

[DewDiligence]

ENTA's share price is back to where it was before the EDP-721-related sell-off last week.

[DewDiligence]

Re: Observed fall-off in Molnupiravir efficacy

It’s baffling that Molnupiravir efficacy dropped precipitously from the interim analysis to the final analysis; during the post-interim portion of the trial, patients in the Molnupiravir arm actually did worse than those in the placebo arm.

Moreover, in a trial such as this one with a very short treatment period (5 days), it’s unlikely that crossover from the placebo arm to the Molnupiravir arm after unblinding could have had a material impact on efficacy.

The FDA advisory panel for MRK’s EUA request is next Tuesday. Perhaps we’ll have a better understanding of what happened after the meeting.

[DewDiligence]

Re: Observed fall-off in Molnupiravir efficacy

From #msg-166912284 (posted last week):

It’s baffling that Molnupiravir efficacy dropped precipitously from the interim analysis to the final analysis; during the post-interim portion of the trial, patients in the Molnupiravir arm actually did worse than those in the placebo arm.

Moreover, in a trial such as this one with a very short treatment period (5 days), it’s unlikely that crossover from the placebo arm to the Molnupiravir arm after unblinding could have had a material impact on efficacy.

The FDA advisory panel for MRK’s EUA request is next Tuesday. Perhaps we’ll have a better understanding of what happened after the meeting.

MRK’s presenter at the FDA adcomm just said that he has no valid explanation for the observed fall-off in Molnupiravir’s efficacy relative to placebo in the portion of the trial following the interim analysis other than that the placebo arm overperformed (LOL).

[biocqr]

Out of 92 Sars-Cov-2 infected pts treated w/molnupiravir none had detectable virus after 3 days...

Merck and Ridgeback to Present Data Demonstrating That Treatment With LAGEVRIO™ (molnupiravir) Was Associated With More Rapid Elimination of Infectious SARS-CoV-2 Than Placebo

https://www.businesswire.com/news/home/20220401005097/en/

In participants with infectious virus isolated at baseline and for whom post-baseline infectivity data were available, molnupiravir was associated with more rapid elimination of infectious virus than placebo. At Day 3 of treatment, among patients with infectious virus at baseline, infectious SARS-CoV-2 was detected in 0.0% (n=0/92) of patients who received LAGEVRIO, compared with 21.8% (n=20/96) of patients who received placebo. At Day 5, infectious virus was detected in 0.0% (n=0/91) of patients in the LAGEVRIO arm compared with 2.2% (n=2/89) in the placebo arm. At Day 10, no infectious virus was detected in either arm for patients with infectious virus at baseline. Molnupiravir was also associated with greater mean reductions from baseline in SARS-CoV-2 RNA than placebo from Days 3 through 10, though molnupiravir and placebo were associated with comparable rates of viral RNA clearance through Day 29.