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Posted On: 11/25/2023 2:43:35 AM
Post# of 148891
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This is a stretch I know, but I believe we had the PDUFA panel meeting. And the FDA reviewed the PIVOTAL PH 2b/3 trial data for HIV-MDR. Whats wrong with this thesis: A) Those meetings are PUBLIC (this was not)
What basis do you have for believing "PDUFA" meetings are public? I think you're confusing two different types of meetings. After a BLA is accepted any discussion of the BLA is inter-agency unless the FDA requests clarification or further data. Then it involves the FDA and the sponsor and that is not public either. The meeting that did take place between the FDA, the sponsor and key opinion leaders was a privileged meeting and would never be open to the public.
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Why would FDA then give CYDY a choice of 5 sub-populations if we are getting FDA approval on HIV-MDR?
They wouldn't. Any post-approval study would be for whatever patient population it was approved for. If Cytodyn were given HIV approval for the previous BLA submission there would be no need for the FDA to request other sub-populations because it would solely be Cytodyn's decision to pursue other populations.
The FDA is almost certainly pushing Cytodyn for a new trial trying to optimize the best chance for approval. Whether that's because of backlash due to Suzanne Strayhorn or because Dr. Lalezari or maybe someone within the FDA itself pushed for it. We certainly will never know.
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