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gestalt2

11/10/17 8:00 PM

#18110 RE: Inoviorulez #18109

Thanks, maybe I’m reading into this too much.
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BlackDoggie

11/10/17 8:04 PM

#18111 RE: Inoviorulez #18109

That would be a very simple answer - if the data was available, that is. There is zero indication that any data on primary endpoints was available, since it's a double-blind trial and it had not been unblinded at that point. In fact, one of the big concessions from the FDA was that CYDY could unblind data on the first 40 and conduct interim endpoint analysis.

Plain and simple, the FDA didn't have the primary endpoint data on 10/12. Unless we're all being blatantly and openly lied to by both the company and the FDA. If you want to argue that they were suggesting that the open label portion of the trial (24 weeks in conjunction with optimized background HAART) is what the FDA was looking at, I can accept that as plausible and still disagree with you.
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pearsby09

11/11/17 11:14 AM

#18112 RE: Inoviorulez #18109

WOW, Really.....

The FDA changed their minds after they saw the submitted results/data. The FDA decided that for the data to be clinically relevant Cytodyn would have to have 50 patients total for analysis. Plain and simple the FDA changed their minds along the way.

The FDA wanted more subjects AFTER seeing the interim results? First off, that should never happen, secondly, if true, that does not bode well for the data. Thirdly, I think many here are crossing into the conspiracy land.