Adial Provides Business Update Following Favorable Comments From US And EU Regulatory Meetings
Portfolio Pulse from Happy Mohamed
Adial Pharmaceuticals has received positive feedback from US and EU regulators regarding the development of AD04, a treatment for Alcohol Use Disorder (AUD). The regulators acknowledged the importance of ongoing research in the AUD therapeutic area and confirmed the primary US endpoint based on Percentage of No Heavy Drinking Days. Adial plans to focus its efforts on the US, as the US standards should translate to acceptance in other international markets. The company expects to register AD04 with the FDA in Q3 of 2025, with the trials costing approximately $25 million in total.
July 11, 2023 | 12:43 pm
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Adial Pharmaceuticals has received positive regulatory feedback for its AUD treatment, AD04. The company plans to focus its efforts on the US market and expects to register AD04 with the FDA in Q3 2025.
The positive feedback from regulators is a significant step forward for Adial Pharmaceuticals. It indicates that the company is on the right track with its development of AD04. The focus on the US market, which should translate to acceptance in other international markets, is a strategic move that could potentially increase the company's market reach. The expected registration of AD04 with the FDA in Q3 2025 is a clear timeline that investors can look forward to.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100