CytoDyn has submitted the first section (non-clinical) of its Biological License Application (BLA) for that indication and our team is working diligently on the remaining two portions of the BLA (clinical, CMC). The FDA previously granted Fast Track Designation (FTD) and recently granted Rolling Review for Leronlimab (PRO140), 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 is also conducting an investigative monotherapy trial for HIV. In addition, the Company has filed with the FDA a pivotal trial protocol for Leronlimab as a monotherapy. If the protocol is accepted and the trial is successful, it would represent a true paradigm shift in the way HIV is currently treated.