Acasti Pharma Announces Submission of TRILOGY 1 Briefing Package to FDA
Acasti Pharma, Inc. - Class A (ACST)
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Source: GlobeNewswire
FDA response expected on or before June 30, 2020 Acasti also received notice of issuance of a Composition of Matter Patent in Hong Kong LAVAL, Quebec, April 30, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that it submitted its briefing package on April 29, 2020 to the Food and Drug Administration (FDA) for review. The Company is currently awaiting comments, and expects a formal response from the FDA on or before June 30, 2020. As previously reported, Acasti filed its meeting request at the end of March, and this briefing package is now intended to provide the FDA with a review of the relevant TRILOGY 1 data and audit findings, with the objective to gain alignment on the interpretation of the TRILOGY 1 resul
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