PhaseBio recently received formal written minutes from the FDA following its Pre-BLA Meeting held in early April and is expecting to submit its Biologics License Application (BLA) by early in the fourth quarter of 2022
The FDA indicated willingness to accept a BLA with data from 25-30 uncontrolled bleeding patients, in addition to surgical patients enrolled to date, to potentially support a label that includes both surgical and uncontrolled bleeding indications
To date, PhaseBio has enrolled 35 uncontrolled bleeding patients and has completed enrolling surgical patients in the Phase 3 REVERSE-IT trial
