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Acasti Pharma: FDA Requires Pivotal Efficacy Analyses For TRILOGY 2

Acasti Pharma Inc. (ACST) said the FDA has provided the company with a written response to its Type C Meeting request and briefing package. The FDA confirmed that it will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat population as contemplated in the original Statistical Analysis Plan, and they supported the conduct of post-hoc analyses in TRILOGY 1. Depending on the outcome of TRILOGY 2, an additional clinical study may still be needed prior to an NDA submission.

Acasti Pharma said the company and its expert advisors are carefully considering the FDA's comments on the TRILOGY 1 data and will conduct further post-hoc analysis based on the feedback.

Shares of Acasti Pharma were down more than 20% in pre-market trade on Friday.

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