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CT Medic, why will we not have a HIV BLA this year?

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In the context of a fast track designation, the FDA has 6 months to render a decision on a filing -- and the clock starts after they have officially accepted a cured BLA submission and issued a PDUFA date.

September 4 only marks the date that the FDA addresses CytoDyn's questions. It is unknown how many additional rounds of questions might take place, or how long it will take the company to prepare and submit the new BLA submission.