Ann: US FDA Completes Review of IHL-42x IND Application, page-42

Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) chief medical officer Dr Mark Bleakley speaks with Proactive after the company received clearance from the US Food and Drug Administration (FDA) to begin a Phase 2/3 clinical trial for its IHL-42X asset, designed to address obstructive sleep apnoea (OSA). The clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic-assisted psychotherapies for unmet needs received the approval after submitting an Investigational New Drug (IND) application to the FDA last month. With the milestone approval in the bag, Incannex will proceed with the finalisation of institutional review board applications and submissions for the lead clinical trial sites.


Dr Mark bit cautious about what comes after the Trial is completed.

GLAH