- Adial Pharmaceuticals Inc ADIL shares are trading higher after an update on its regulatory strategy for AD04, the company’s lead compound for Alcohol Use Disorder (AUD).
- The company said additional analysis of ONWARD data identified specific genotypes that outperformed others. The data exhibited AD04 achieved a statistically significant reduction of heavy drinking days in a subgroup of patients – the “heavy drinkers.”
- Adial believes there is a clear, cost-effective path toward FDA approval that it plans to pursue aggressively.
- Also Read: Adial Pharma Touts Positive Preclinical Data From Chronic Pain Candidate.
- Based on the information collected and analyses to date, Adial has submitted a Type C meeting request to the FDA and was granted a meeting, which will be held in Q2 of 2023.
- The Type C meeting is expected to provide Adial with confirmation of a clear clinical development plan.
- As previously anticipated, an additional Phase 3 trial may be required. Adial intends to engage a U.S. partner to assist with funding the required clinical trial and to advance commercialization efforts.
- Adial is progressing discussions with five European country-level regulatory authorities: France, Sweden, Finland, the U.K., and Germany.
- Meeting dates with Sweden and Germany are scheduled for March and April of 2023, respectively, and the remaining countries’ schedules are pending confirmation.
- Price Action: ADIL shares are trading flat at $0.42 on the last check Tuesday.
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