Adial announces receipt of final meeting minuts from EOP2 meeting with FDA

Adial Pharmaceuticals (ADIL) announced receipt of the final meeting minutes from its End of Phase 2, EOP2, Meeting with the U.S. Food and Drug Administration, FDA, held on July 29, 2025. The minutes provide the FDA’s formal input into the AD04 Phase 3 adaptive clinical trial design and broader clinical development strategy. This positive feedback marks a key milestone in advancing AD04 toward registration. “We believe we are at an inflection point in Adial’s journey,” commented Cary Claiborne, CEO of Adial. “The successful completion of our End of Phase 2 meeting with the FDA has provided critical guidance that strengthens the clinical and statistical framework for our upcoming Phase 3 trial of AD04. With regulatory alignment on key protocol elements, including patient population, efficacy endpoints, biomarker stratification, and adaptive enrichment strategies-we are now positioned to advance a streamlined and scientifically rigorous program designed to maximize the probability of success.”