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DewDiligence

03/04/18 6:57 PM

#217668 RE: jbog #217667

RVNC—The RT002 BLA submission is awaiting completion of SAKURA-3, the open-label safety study that includes repeat injections for glabellar lines and follows patients for 12 months:

https://www.clinicaltrials.gov/ct2/show/NCT03004248

If the FDA permits RVNC to submit the BLA based on interim SAKURA-3 data (to be updated with the final data during the BLA review), then RT002 could be on the market in late 2019 rather than 2020.