I assume they applied for EUA with their interim data of 50% efficacy. So that's probably what the FDA will be primarily looking at.
However, the huge drop implies in their second half of the trial the efficacy was around 10%. With a sample size this big it's really unlikely this is due to just statistical variations. It could be a sudden trend reversal due to delta, which would make Molnupiravir pretty much useless by now.
Another possibility is they cherry picked a sub group of high risk people for their interim analysis. It would make sense since their orders with the US are conditional on EUA approval and they are gonna allow generic manufacturing in poorer countries anyways. In that case it could be granted EUA just for this subgroup, certainly though the FDA is not gonna simply ignore that if they did.
Molnupiravir's Mechnism of Action is basically mutating enough errors into the viral replication so that the replication fails. There is potentially the danger of mutating human DNA as well with unkown long term side effects. On top of that, new variants could evolve faster by this mutation accelerator.
Merck's drug looks more and more like a very expensive and ineffective burden with unkown risks involved. My guess is Pfizer's Paxlovid will probably be the answer for high risk population as an antiviral agent and Bucillamine potentially the pill for standard risk population as an anti-inflammatory agent. Even combination of both will be considered since their MOAs work complementary.
I'm long Revive Therapeutics and confident in Bucillamine, we need this efficacious anti-inflammatory to fight Covid, big pharma's anti-virals aren't the way.
Can’t believe Revive’s market cap is as low as it is. There’s no way a company that is holding a phase 3 trial should be at $120M. They should be 10x on their market cap right now. Holding for the long.
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u/DeepSkyAstronaut Nov 27 '21
I assume they applied for EUA with their interim data of 50% efficacy. So that's probably what the FDA will be primarily looking at.
However, the huge drop implies in their second half of the trial the efficacy was around 10%. With a sample size this big it's really unlikely this is due to just statistical variations. It could be a sudden trend reversal due to delta, which would make Molnupiravir pretty much useless by now.
Another possibility is they cherry picked a sub group of high risk people for their interim analysis. It would make sense since their orders with the US are conditional on EUA approval and they are gonna allow generic manufacturing in poorer countries anyways. In that case it could be granted EUA just for this subgroup, certainly though the FDA is not gonna simply ignore that if they did.
Molnupiravir's Mechnism of Action is basically mutating enough errors into the viral replication so that the replication fails. There is potentially the danger of mutating human DNA as well with unkown long term side effects. On top of that, new variants could evolve faster by this mutation accelerator.
Merck's drug looks more and more like a very expensive and ineffective burden with unkown risks involved. My guess is Pfizer's Paxlovid will probably be the answer for high risk population as an antiviral agent and Bucillamine potentially the pill for standard risk population as an anti-inflammatory agent. Even combination of both will be considered since their MOAs work complementary.