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Posted On: 07/22/2023 1:48:38 PM
Post# of 148891
Re: HouseofCards #135920
In covid it's very difficult to show efficacy in mild to moderate patients and our high p-values reflected that. And with it being underpowered there was no way we could have expected an EUA off of the first M2M study.
Where we may have gotten screwed is in the severe to critical trial with the FDA guiding us to use 2 doses instead of 4. I think most folks in the know believe that we could have shown efficacy with 4 doses considering the improvement leronlimab seemed to show after 2 doses. It's just that the trial continued an extra couple of weeks without those 2 extra follow-up doses.
I've seen some posts about Monday maybe being somewhat of a nothingburger but I thought the last call had important info about the progress of NASH and the hold and I'm looking forward to more on Monday even if there's no special news updates dropped.
Where we may have gotten screwed is in the severe to critical trial with the FDA guiding us to use 2 doses instead of 4. I think most folks in the know believe that we could have shown efficacy with 4 doses considering the improvement leronlimab seemed to show after 2 doses. It's just that the trial continued an extra couple of weeks without those 2 extra follow-up doses.
I've seen some posts about Monday maybe being somewhat of a nothingburger but I thought the last call had important info about the progress of NASH and the hold and I'm looking forward to more on Monday even if there's no special news updates dropped.
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