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DewDiligence

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DewDiligence

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Re: DewDiligence post# 244998

Saturday, 02/25/2023 4:21:18 PM

Saturday, February 25, 2023 4:21:18 PM

Post# of 257305
RVNC manufacturing expansion for CD launch…

RVNC submitted a PAS* to the FDA in Oct 2022 to enable manufacturing of Daxxify at Ajinomoto’s site in San Diego (https://investors.revance.com/news-releases/news-release-details/ajinomoto-bio-pharma-services-and-revance-therapeutics-announce ; https://investors.revance.com/news-releases/news-release-details/revance-reports-third-quarter-2022-financial-results-provides [see the sixth bullet under the heading, “Third Quarter Highlights and Subsequent Updates”].

FDA approval of the manufacturing PAS should come before—or concurrently with—FDA approval of Daxxify for cervical dystonia, enabling RVNC to have sufficient production volume for the CD launch.

*Prior-Approval Supplement.

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