Adial Pharmaceuticals Inc's shares are trading higher after the company provided a summary of feedback from recent meetings with U.S. and EU regulators and an update on its clinical development plan. The regulators confirmed the primary U.S. endpoint and acknowledged the results from the Phase 2 and Phase 3 post hoc analysis. The FDA agreed to Adial's plan to comply with ICH E1A by adding a long-term safety follow-up to the planned Phase 3 trial. The company expects to register AD04 with the FDA in Q3 of 2025, with an approximate cost of $25 million.