Evoke Pharma request Type A FDA meeting for resubmission of Gimoti NDA
Evoke Pharma announced that it has submitted a type A meeting request and meeting package to the U.S. Food and Drug Administration to discuss the Complete Response Letter dated April 1, 2019 regarding Evoke's New Drug Application for Gimoti for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. The purpose of the meeting is to discuss and gain clarity on the approvability issues relating to clinical pharmacology and product quality/device quality described in the CRL. During the meeting, Evoke plans to discuss the Company's strategy to address these issues as well as any other matters pertaining to the steps required for the resubmission of the Gimoti NDA. No safety concerns were raised and no additional clinical data were requested in the CRL. The type A meeting, if granted, is expected to occur within thirty days of FDA's receipt of the meeting request and meeting package. Evoke will provide an update on the timing of resubmission of the NDA for Gimoti after receipt of the FDA's final meeting minutes, which typically become available within thirty days after the type A meeting.