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Posted On: 09/17/2020 11:15:19 AM
Post# of 149323
Gestalt,
I believe that the remdesivir EUA was based on the ACTT trial, 1063 enrolled.
Time to recovery inserted as primary endpoint as it became clear early in trial that more rigorous endpoints would not be met.
Very weak clinical efficacy IMO.
However, the environment of anxiety verging on panic has changed and Gilead, FWIW, is a big player and Cytodyn is not.
I am disappointed but not surprised that Cytodyn was told to come back with s/c results.
For those lambasting the failure to obtain EUA(messaging is another issue), please recall that trial structure was filed March 9, and approved by FDA later in March after modified to FDA expectations.
Cytodyn exceeded expectations in CD10. Approval was almost certainly never going to happen from 75 patient phase 2. EUA was a crap shoot that did not happen because of changing environment, not Cytodyn failure.
I believe that the remdesivir EUA was based on the ACTT trial, 1063 enrolled.
Time to recovery inserted as primary endpoint as it became clear early in trial that more rigorous endpoints would not be met.
Very weak clinical efficacy IMO.
However, the environment of anxiety verging on panic has changed and Gilead, FWIW, is a big player and Cytodyn is not.
I am disappointed but not surprised that Cytodyn was told to come back with s/c results.
For those lambasting the failure to obtain EUA(messaging is another issue), please recall that trial structure was filed March 9, and approved by FDA later in March after modified to FDA expectations.
Cytodyn exceeded expectations in CD10. Approval was almost certainly never going to happen from 75 patient phase 2. EUA was a crap shoot that did not happen because of changing environment, not Cytodyn failure.
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