No — The FDA did not say the last BLA submission
Post# of 153591
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Posted On: 05/25/2025 4:14:39 PM
Re: USS JOHNSTON #153536
No — The FDA did not say the last BLA submission by CytoDyn was reviewable.
Here’s what happened:
CytoDyn submitted the BLA for leronlimab (for HIV, monotherapy).
The FDA issued a Refuse to File letter, indicating the BLA was not complete or properly formatted enough to even begin the formal review process.
CytoDyn later filed a lawsuit against its former CRO (Contract Research Organization), Amarex, alleging gross negligence in preparing the BLA. They claimed Amarex’s submission lacked required datasets, was not in the appropriate eCTD (electronic Common Technical Document) format, and failed to meet FDA regulatory standards.
The FDA never began a formal scientific review of that BLA — because they never accepted it in the first place.
Here’s what happened:
CytoDyn submitted the BLA for leronlimab (for HIV, monotherapy).
The FDA issued a Refuse to File letter, indicating the BLA was not complete or properly formatted enough to even begin the formal review process.
CytoDyn later filed a lawsuit against its former CRO (Contract Research Organization), Amarex, alleging gross negligence in preparing the BLA. They claimed Amarex’s submission lacked required datasets, was not in the appropriate eCTD (electronic Common Technical Document) format, and failed to meet FDA regulatory standards.
The FDA never began a formal scientific review of that BLA — because they never accepted it in the first place.
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