ITEM 8.01 OTHER EVENTS OnJanuary 18, 2022 ,Revance Therapeutics, Inc. (the "Company") announced that it received the official Type A meeting minutes from theUnited States (U.S.) Food and Drug Administration (the "FDA") regarding the Complete Response Letter ("CRL") previously issued with respect to the Company's Biologics License Application (the "BLA") for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar (frown) lines. The Type A meeting was held onDecember 15, 2021 . Based on the meeting minutes, received by the Company onJanuary 14, 2022 , a complete response to address the outstanding observations related to the working cell bank ("WCB") and the drug substance manufacturing process will require the Company to qualify its new WCB by producing three consecutive drug substance lots and one drug product lot. The qualification of the new WCB has been underway, and the Company plans to submit the new WCB qualification package as part of its BLA resubmission as soon as possible. A reinspection of the Company's manufacturing facility will be required once the resubmission is accepted by the FDA.
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