Biotech Values

[DewDiligence]

RVNC—Is there a chance the FDA didn't accept the sBLA for CD yet? I don't see a PR from the company w a PDUFA date.

RVNC has not (yet) issued a PR confirming FDA's acceptance of the sBLA (for review), but that doesn't imply RVNC is getting an RTF letter. RVNC could simply be waiting until January to issue a PR containing not only the PDUFA date, but also some 2023 guidance (as many biotech companies do at the start of a new year).

An RTF is conceivable but is quite unlikely, IMO.