Oct. 28 at 12:15 AM
$OMER I learned something new today - FDAs voluntary Postmarketing commitment (pmc) vs mandatory Postmarketing requirement (pmr) (phase 4) for post approval.
I would guess that voluntary PMC would be enough for Narsoplimab and the collected RWE (real world evidence) data could be basis for label expansion later.
Even if the FDA requires mandatory phase 4, then the company has enough funds for that.
Phase 4 is more likely used when surrogate endpoints were used for approval, which is not the case here.
