“IMO, ideally, the extreme critically ill should not effect our % reduction of deaths and thus should not effect our p value and thus, should not effect the probability of obtaining a s/c EUA.”
Unfortunately, that’s not how the trial was written. The exclusion criteria will eliminate some of the most critical from the trial (needing dialysis or on X dose of vasopressors for more than 48 hours). Hopefully it will not be needed, but a deeper dive of the data could show a subset of the S/C population (maybe just the severe) responded at a much higher rate than the critical population.
Unfortunately, that’s not how the trial was written. The exclusion criteria will eliminate some of the most critical from the trial (needing dialysis or on X dose of vasopressors for more than 48 hours). Hopefully it will not be needed, but a deeper dive of the data could show a subset of the S/C population (maybe just the severe) responded at a much higher rate than the critical population.
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