We believe that our Biologics License Application (BLA) is approvable based on conversations with the U.S. Food and Drug Administration (FDA), as of our Prescription Drug User Fee Act (PDUFA) date of April 1 and through today.
We have recently received formal communication from the FDA in the form of an information request for a postmarketing commitment (PMC) to generate additional clinical data. We look forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible.
