Replies to post #573 on Revance Therapeutics Inc (RVNC)

[DewDiligence]

Re: RT002 safety studies for various indications

The competed SAKURA-3 study—which had 2,700 patients and 3,800 injections (https://investors.revance.com/news-releases/news-release-details/revances-rt002-demonstrates-unprecedented-efficacy-and-duration )—ought to be a sufficient safety database for any aesthetic indication where the dose is 40U, which probably includes crow’s feet, lateral forehead lines, and any other aesthetic indication that may be pursued.

For therapeutic indications such as CD, where the dose is much higher than in aesthetic indications, a separate safety trial is needed and is already established. Called ASPEN-OLS, it will include 350 CD patients who receive multiple injections and are followed for 52 weeks (https://www.clinicaltrials.gov/ct2/show/NCT03617367 ); some of the 350 patients in ASPEN-OLS will be “rollovers” from the phase-3 efficacy trial in CD called ASPEN-1 (https://www.clinicaltrials.gov/ct2/show/NCT03608397 ).

The ASPEN-OLS study (above) ought to suffice for other movement-disorder indications such as upper-limb spasticity.

Therapeutic indications such as PF, which involves a smaller dose than CD, should be able to piggyback on ASPEN-OLS, but may require a separate, small safety study.

All told, the above is (IMO) a well-conceived plan to support multiple aesthetic and therapeutic indications without incurring unduly high clinical-trial expenses.