Adial Pharmaceuticals announced on June 16, 2025, that it has submitted a briefing package to guide its upcoming End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). The EOP2 meeting has been rescheduled for July 29, 2025.
The meeting's purpose is to discuss the upcoming clinical development plan and protocol designs for AD04, Adial’s lead investigational drug for Alcohol Use Disorder (AUD). This submission is a critical preparatory step for the pivotal regulatory interaction.
Strategic partnership discussions are expected to accelerate following a positive outcome from the FDA meeting. This submission ensures that Adial is prepared to align with the FDA on key aspects of its Phase 3 clinical program.
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