Acasti Pharma Says Received Positive Feedback from FDA on Proposed Development Pathway for Capre

Acasti Pharma Inc.

announces that it has received positive feedback from the US Food and Drug Administration (FDA) on the proposed development pathway for CaPre®. "Recently, we received encouraging comments from the FDA based on our briefing package submission indicating that the 505(b)(2) pathway represents a course for regulatory review and approval, and that Acasti's plans for the bioavailability bridging study are viewed as sound," highlighted Pierre Lemieux, PhD, Acasti's Chief Operating Officer.  "With this endorsement, Acasti will submit an amendment to its current Investigational New Drug (IND) application to commence a bridging study, while continuing to work closely with the FDA to ensure the Corporation is aligned with their views on CaPre® clinical development." As previously announced, the 505(b)(2) approval pathway has been used by many other companies to secure approval