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CytoDyn Inc CYDY
(Total Views: 655)
Posted On: 01/08/2022 3:32:45 PM
Post# of 153976
Posted By: Heads
I refuse to get pessimistic following this ugly week, so here I go with my cockeyed optimistic thought: If we update our TNBC survival numbers and those numbers are significantly better than Trodelvy numbers (which we expect them to be), then perhaps we could be looking at "Accelerated Approval" this year in addition to BTD. After all, if Leronlimab has significantly better survival and safety than Trodelvy, why not grant us Accelerated Approval like Trodelvy had previously received. Perhaps this is the real reason why the FDA is asking for the updated survival numbers - to consider AA in addition to BTD.













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