Biotech Values

[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).