So I'm not quite sure how this new 140 patient tri
Post# of 154065
(Total Views: 413)
Posted On: 03/08/2021 7:46:43 PM
So I'm not quite sure how this new 140 patient trial is going to work. If we are trying to prove that we save lives in critical patients, we have to have a placebo arm, why I'm not quite sure when the FDA has access to SOC on 24 million patients. But this puts us into a real catch 22 position. We have to stop eIND and who would want to put their patient into a trial with the possibility of getting the placebo.
Why can't we just get an EUA for critical and see how well we do with 140 patients? I mean didn't the FDA do that with the vaccines, didn't they continue trials while give the drug out? Can't our management push for that?
Why can't we just get an EUA for critical and see how well we do with 140 patients? I mean didn't the FDA do that with the vaccines, didn't they continue trials while give the drug out? Can't our management push for that?
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