Biotech Values

[DewDiligence]

The sBLA PDUFA date for cervical dystonia will be in Aug 2023 (unless there is some kind of glitch). RVNC hasn’t disclosed whether the sBLA is seeking approval for both the 125U and 250U doses, but based on the phase-3 data I expect that the approval will be for the 125U dose.

I concur that approval in CD will generate off-label sales for other movement disorders such as ULS, and I even think there will be some off-label sales for movement disorders before approval of the sBLA (#msg-170186348). However, off-label sales in migraine will be de minimis, IMO.