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Posted On: 10/13/2020 10:04:37 AM
Post# of 155757
Re: onestepahead #60915
Onestepahead,
Well, they can do that AFTER they un-blind. However, when the drug/placebo was administered it was done indistinctly.
You are right in that we can calculate effectiveness vs SOC discriminating the groups (Severe and Critical) but FDA will normally require a trial with the group in question to approve.
Also, I agree with you hat if FDA was conscious and, seeing our effectiveness in whatever group, a EUA should be forthcoming taking into account the excellent safety of LL (this is a HUGE plus).
Quote:
I would imagine that they can differentiate how many severed and how many critical patients in each arm of the trial. Trail design is overall mortality reduction with mixed patients.
Well, they can do that AFTER they un-blind. However, when the drug/placebo was administered it was done indistinctly.
You are right in that we can calculate effectiveness vs SOC discriminating the groups (Severe and Critical) but FDA will normally require a trial with the group in question to approve.
Also, I agree with you hat if FDA was conscious and, seeing our effectiveness in whatever group, a EUA should be forthcoming taking into account the excellent safety of LL (this is a HUGE plus).
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