Cytodyn Inc (CYDY)

[SmileyRiley_595]

I am not blind to the fact certain criticisms are due CYDY management’s goal of turning Leronlimab into a commercial revenue generator. However, I find the consistent harping on the RTF letter to be overdone at this point. I realize when you combine this isolated event with other miscues, it’s pouring more salt on old wounds, but even the most established pharmaceutical companies aren’t immune to receiving this response from the FDA for a myriad of reasons. In a 5 minute internet search, I identified dozens of RTF letters to companies like Roche, J&J, Pfizer, Novartis, and even the FDA’s current darling SOC for Covid-19 Gilead...




Interestingly enough, Gilead’s Truvada & TMC278 received a RTF letter due to its analytical methodology/qualification data which is a far cry more troubling than f’n syringes and adding data at the FDA’s request that wasn’t a part of the BLA submission in the first place! My opinion is CYDY is approaching their response to the RTF very methodically b/c, they want to understand exactly how the FDA intends to use the 700mg dose data set and how they want to see that information illustrated. For that reason only, I’m am holding out further criticism on this topic and I would suggest others do the same.