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Posted On: 04/17/2023 1:22:03 PM
Post# of 156193
As some have posted elsewhere over the wknd, it is genuinely intriguing that mgmt said they were pulling and abandoning the BLA for HIV yet the frequently updated company website says this:
It would appear an HIV BLA is absolutely in play, and with all the back-and-forth lately with the FDA perhaps it'll be completed (and approved) sooner rather than later.
Quote:
FDA Fast Track Designation for Leronlimab
CytoDyn has submitted the first two sections (non-clinical and CMC) of its Biological License Application (BLA) for that indication and our team is working diligently on the clinical section. The FDA previously granted Fast Track Designation (FTD) and granted Rolling Review for leronlimab (PRO 140), which facilitates frequent interactions with the FDA review team. The Rolling Review process allows CytoDyn to submit individual sections of the BLA for review, rather than waiting on FDA review until all three sections are completed and filed.
CytoDyn also completed an investigative monotherapy trial for HIV.
It would appear an HIV BLA is absolutely in play, and with all the back-and-forth lately with the FDA perhaps it'll be completed (and approved) sooner rather than later.
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