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Posted On: 07/15/2020 12:12:44 AM
Post# of 149727
Certainly combo phase 3 at 350 milligrams, and the switich to 700 upon the FDA's initiative makes this a very, very unusual situation.
It is possible that the FDA has never approved a drug at a higher dose than what was used in the phase 3 trials, but i have no clue.
Maybe Cytodyn should say, "Hey quit messing around, just approve the combo at 350".
Seems to me that Cytodyn should be pissed off that the FDA is jerking them around, but maybe the 700 approval on the combo really is the FDA doing CYDY a favor.
And what exactly is the point of re-analyzing data? Either its safe at 700 or its not. Hard to imagine what the point of data reanalysis is.
Certainly a confusing situation. Small wonder Pourhassan needs a meeting before offering a timeline to resolution.
It is possible that the FDA has never approved a drug at a higher dose than what was used in the phase 3 trials, but i have no clue.
Maybe Cytodyn should say, "Hey quit messing around, just approve the combo at 350".
Seems to me that Cytodyn should be pissed off that the FDA is jerking them around, but maybe the 700 approval on the combo really is the FDA doing CYDY a favor.
And what exactly is the point of re-analyzing data? Either its safe at 700 or its not. Hard to imagine what the point of data reanalysis is.
Certainly a confusing situation. Small wonder Pourhassan needs a meeting before offering a timeline to resolution.
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