Last week, everybody’s favorite pink sheet reverse-merger Coronacrapper, Cytodyn (CYDY), began issuing a barrage of press releases (read about one here) culminating in one of their now-famous CONference calls, which you can watch here. In these calls, The NaDDiR* and his klown krew mumble incoherently, throw around tons of buzz words, and generally try to keep the suckers happy as the stock promotion lurches from one pivot to another.
On December 9, 2021, one of the Cytodyn press releases trumpeted the filing of an Expanded Access Protocol request by the company with the FDA, to allow for the use of loserlimab in HIV patients. Read it here. Expanded Access allows companies to offer unapproved drugs to patients outside of a clinical trial. Said the company:
Just five days later, on the December 14th CONference call, The NaDDiR* let this slip:
Ooops. A problem with the protocol. Did NaDDiR actually admit they “didn’t do a good job” with the submission? What could be the problem? The FDA accepts ~99% of EA submissions, so what are the reasons why the FDA would reject a submission for Expanded Access? That’s easy. The list is here:
If the curmudgeons at BuyersStrike! HQ had to guess, the FDA probably determined that either under part 2, Cytodyn was not actually pursuing marketing approval with appropriate diligence (ie the BLA submission was a pathetic joke) or part 3, there is not sufficient clinical evidence of effectiveness. Cytodyn only reports the results of one tiny Phase 3 study in HIV, and has offered no confirmatory evidence.
Just more of the endless Cytoklowning from the Klown Krew.
* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping
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