Thursday, April 22, 2021 6:02:13 PM
Actually CTMedic knows very much , personally I make sure I always read his posts.
And FDA is a major actor in any study , they approving what type of studies are done..
For egz they approved for Remdesivir and Lenzilumab Adaptive design of the study when company knows the results during the study without any penalties , and may easy choose properly primary endpoint , no big deal really ...
why not, they see the results.
And as in our protocol , Dr Lalezari , Dr Yang and Dr Harish S, wanted to have 4 injections , but FDA didn't approve this , they didn't think it is needed.
So yes , FDA may produce a lot of damage to any study..
All IMO.
And FDA is a major actor in any study , they approving what type of studies are done..
For egz they approved for Remdesivir and Lenzilumab Adaptive design of the study when company knows the results during the study without any penalties , and may easy choose properly primary endpoint , no big deal really ...
why not, they see the results.
And as in our protocol , Dr Lalezari , Dr Yang and Dr Harish S, wanted to have 4 injections , but FDA didn't approve this , they didn't think it is needed.
So yes , FDA may produce a lot of damage to any study..
All IMO.
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