Sorry just frustrating, can anyone with a medical background help me make sense of this. Because it absolutely doesn’t. I hate going to the conspiracy corruption idea but literally nothing else makes sense to me or it’s pure stupidity of our government and cydy. This process is broken period. We should have had EAU this entire time....
There are 2 moves, which indicate the FDA has "changed"...."adapted" and probably "improved".
1) they asked for our s/c data as soon as it was unblinded.
2) they issued the new "Guidelines For Monoclonal Antibodies" (link below) which implies looser criteria for EUA approvals and creative actions to attack the out of control covid-19 virus.
3) thus, the FDA is probably "actually" in discussions with Cytodyn, regarding either or both of the above, and/or issues such as manufacturing, pricing, which countries will get vials beside the USA (supply is limited), which patients will get Leronlimab, which sub-groups of s/c will most likely benefit (thus, a customized or limited EUA)
4) The US gov't can activate an existing law whereby they can stop all shipments of Leronlimab out of the USA
If data results are great, it makes sense that the FDA would want to discuss and provide input and even dictate some of Cytodyn's actions for selling.