FDA accepts updated rolling review timetable for leronlimab as a combination therapy for HIV patients.

Rolling review enables a drug company to submit completed sections of its BLA for contemporaneous review by the FDA, rather than waiting until every section of the BLA is complete before the entire application is reviewed.

The Company also announced that it expects the non-clinical and CMC sections of the BLA to be resubmitted to the FDA in November and, as previously disclosed, the clinical section of the BLA is anticipated to be completed and resubmitted during the first quarter of calendar 2022.