Adial Pharmaceuticals Highlights FDA Shift Toward Single Pivotal Trial Backed by Confirmatory Evidence

Reuters02-23 21:31

<a href="https://laohu8.com/S/ADIL">Adial Pharmaceuticals</a> Highlights FDA Shift Toward Single Pivotal Trial Backed by Confirmatory Evidence

Adial Pharmaceuticals said new FDA policy direction could allow some drugs to win approval based on one adequate and well-controlled pivotal trial plus confirmatory evidence, instead of the traditional expectation of two. The company said this shift could materially reduce the cost and time required for Phase 3 development of its lead candidate AD04 for alcohol use disorder, and it plans to discuss an appropriate evidentiary strategy with the FDA.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Adial Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202602230830PRIMZONEFULLFEED9658935) on February 23, 2026, and is solely responsible for the information contained therein.

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