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CytoDyn Inc CYDY
(Total Views: 484)
Posted On: 10/15/2020 6:41:19 PM
Post# of 153778
Posted By: MarcS
Re: henry f #61300
The last thing you would want to do is halt a clinical trial to find out the FDA doesn't agree with you and you have to start the whole trial over, particularly in the middle of a pandemic. The way to avoid that would be the DSMB taking the results directly to the FDA and asking the FDA for their opinion. Someone posted here or somewhere else an FDA rule that seems to suggest this is allowed, but not the normal rule, and again we are in a pandemic which is not normal, so it would seem this is possible. That all said, I think we are all over-reading what the good doctor said. Personally, I don't think he would be in the knowledge loop on this one at this stage of the process. But, what do I know, nothing more, nothing less, than any of you.













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