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My opinion on what happened is that there

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gestalt2   Friday, 11/10/17 06:45:00 PM
Re: BlackDoggie post# 18100
Post # of 18259 
My opinion on what happened is that there seemed to be some confusion between cytodyn and the FDA, the FDA wanted a face to face to resolve something. I feel that cytodyn is asking or expecting a wider label and thought they would get it. the FDA lowered the enrollment to 30 because tai med was allowed to have that trial size but they were looking at a much narrower label. The fact that cytodyn did not really elaborate on why this happened or what the specifics of the discussion suggests there was some sort of misunderstanding that Nader should have been on top of. It could be the 50patients and 300 safety data solves this and ensures a broad label. It could very well be that the FDA could have stuck with the original 150 trial size if at that time cytodyn was asking for a broad label. Either way, I think it is safe to assume Nader was a little loose with the details of the combo trial.

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