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vinmantoo

10/08/23 12:44 PM

#2734 RE: alertmeipp #2732

I think RBCs point is with vaccine, less harmful covid variant and natural immunity, hospitalization rate is lower than before, thus it’s harder than before to show stats significance on the same endpoint. (Reduce hospitalization rate)



I understand their point and appreciate your raising it. However, I am saying it is wrong. Both the hospitalization rate and death rate are high enough in high risk groups to provide a path forward for regulatory approval.

A recent study (2022-2023), which was brought to my attention by dewophile showed that the death rate in the high risk group was 1.4% in people not treated with either Paxlovid or Molnupiravir, and most were vaccinated. For people over 65, the death rate was 3.46%. These data were for a period of 90 days after infection with Covid.

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2809779

So for 235, the regulatory pathway isn’t clear for them. That’s probably one of the reason 235 get discounted by the market even it seems to be superior drug



I sure seems that way.

Hope ENTA can work out the details with FDA and update the market soon



Obviously, so do I. Good luck to us both. We need it.