Replies to post #2528 on Revance Therapeutics Inc (RVNC)

[Jcrem]

I agree with DD on disclosure.

When RVNC said that their resubmission would require a re-inspection they actually indicated that they would be getting a Class 2 resubmission. The FDA states that "A resubmission that requires a reinspection also would be a Class 2 resubmission." FDA Classification Document

So makes sense that they aren't releasing anything because they have no good news to share. Getting acceptance of their CRL resubmission basically just says they are competent, but doesn't give any indication on the quality of the re-submission. Only that the resubmission is a "complete response".

But also agree that given the history a slight nod would be nice, but not sure it matters here. Looking at 6 months for review plus a re-inspection.