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Posted On: 04/17/2023 2:44:39 PM
Post# of 148875
And now it reads:
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.
So if they updated the last line to say it's completed, why not also remove the language about working on the clinical section of the BLA?
Someone explain this to me like I'm 5 years-old.
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.
So if they updated the last line to say it's completed, why not also remove the language about working on the clinical section of the BLA?
Someone explain this to me like I'm 5 years-old.
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