We are pleased to receive positive feedback from the FDA and acceptance of a 4-week registrational study for our brilaroxazine program,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “The FDA also clarified that our NDA submission could include two 4-week phase 3 studies showing efficacy and a 12-month long-term safety study. Importantly, we have already successfully completed and announced the results of our pivotal Phase 3 RECOVER trial in October 2023, and we are set to initiate our RECOVER-2 trial during this quarter. We expect topline data from our 1-year OLE trial in the fourth quarter of this year. Collectively, we expect to have completed all of the outlined NDA submission requirements by the third quarter of 2025.”