Acasti Pharma Submits FDA Meeting Request on Schedule, and FDA Meeting Expected in the Second Half of June [Canadian Business Journal (Canada)]
Acasti Pharma, Inc. (ACST)
Last acasti pharma, inc. earnings: 2/14 08:00 am
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Source: Canadian Business Journal
LAVAL, Québec, April 01, 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 has filed its meeting request with the Food and Drug Administration (FDA). The meeting is intended to discuss TRILOGY 1 data, and gain alignment with the FDA on the interpretation of the results. The Company will also seek the FDA’s input on Acasti’s proposed revisions to the pre-specified TRILOGY 2 statistical analysis plan (SAP), and explore and agree on a plan for pooling the data from TRILOGY 1 and TRILOGY 2 in support of an NDA filing. Acasti remains blinded to the TRILOGY2 results, and intends to update the statistical analysis plan (SAP) with these revisions if the FDA agrees. As previously noted, upon submission of the meetin
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