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Replies to post #226663 on Biotech Values
The BLA will be submitted during November, according to the PR.
Glabellar lines.
In December 2018, we announced top-line results for the SAKURA 3 open-label, long-term safety study. DAXI appeared to be generally well-tolerated with no new tolerability or safety concerns reported. We held a pre-BLA meeting with the U.S. Food and Drug Administration (“FDA”) in December 2018 to agree upon the content and format of the BLA. We are in the process of compiling one of the largest clinical data packages for an aesthetic indication. We have been working in parallel to develop a 100-unit vial in addition to an initial 50-unit vial. This added additional work streams for process validation and stability. We expect to submit the BLA in November 2019, and are on track for a 2020 approval and launch for DAXI for the treatment of glabellar lines. We plan to file marketing applications in the European Union, Canada, and certain Latin American and Asian countries after filing in the U.S.
11/04/19 5:44 PM
02/24/20 6:34 PM
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