Not sure specifically which part you are asking me about.
Re: CYDY, they didn't really do anything wrong, no, except bungle their planning, analysis, and communication on results of the trial.
The FDA put out the letter because shareholders and doctors were making videos, writing congressmen, petitioning the FDA, and in general trying to apply pressure for FDA to approve (EUA) a completely safe drug that helped certain subgroups (critically ill / on mechanical ventilation), but failed on the primary endpoint (28 day mortality in combined severe and critical subjects). CYDY was dumb to go after mortality as primary endpoint in a small trial.
FDA has put up huge roadblocks for CYDY in HIV, requiring a mechanistic test (receptor occupancy) despite excellent clinical efficacy, and requesting a different dosing level than the company ran their trial on which showed such good success! Delayed by several years (cui bono?) their HIV drug. In severe / critical Covid trial, the FDA declined to allow the company to give 4 doses (q. week) and insisted on only 2. Critically ill Covid subjects had 82% mortality benefit at 2 weeks vs. placebo, which fell to something like only 30% at 4 weeks. What if they were allowed to give additional doses at week 2 and 3?
Anyways, that is the CYDY FDA situation, IMO.
With hardly any Covid left in USA, CYDY is doing trials in India and Brazil, and working on approvals overseas now (Canada, Europe, Phillipines, India, and Brazil).
Hopefully IPIX has a better relationship with the FDA. It is supremely important. If there is some success with our Phase II for moderate to severe Covid, I imagine IPIX will be wise to do some of their Phase III trial overseas too.
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