The inference I draw from the Form filed under Rule
The inference I draw from the Form filed under Rule 424(b)3, pages 24-25, is that the FDA has decided to consider granting accelerated approval to LL to treat the HIV MDR population. Many drugs have received accelerated approval over the last few years. Approval requires the use of a surrogate marker from a clinical trial that is reasonably likely to predict clinical benefit and a subsequent confirmatory clinical trial that demonstrates such benefit.
After CYDY submitted the LL safety data prior to Feb 28,2023 in its initial response to the hold, the FDA has twice requested a benefit risk analysis of LL for HIV MDR patients. Benefit risk assessment is the overriding consideration for drug approval, not drug safety. The FDA is also asking CYDY to submit a protocol for a HIV clinical trial for MDR patients. That would be the confirmatory trial.
Yes, I realize the Cyrus announced months ago the the HIV BLA has been withdrawn due to concerns that another Refusal to File would occur, bur pages 24-25 definitely imply, without specifically stating, that the accelerated approval format is now under consideration. Without any supporting information to rely upon, I nevertheless find it plausible that the recent medical histories of the 40 HIV MDR extension arm patients who were denied LL as of the March 2022 clinical hold, may have motivated some of their treating physicians to reach out to CYDY and/or the FDA to petition for the restoration of LL for their patients.
As someone who has grown very wary of the FDA's motives regarding CYDY and LL, I recognize the counter argument that all these additional requests may simply be the next step of an endless delay strategy. Perhaps they are, but based on pages 24 and 25, CYDY management doesn't think so.
26
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