Bionomics announced the favorable outcomes of an EoP2 meeting with the FDA, supporting the advancement of its lead asset BNC210 for the treatment of PTSD into Phase 3 based on the positive results of the recently completed Phase 2b ATTUNE study. The company presented the clinical plans to registration, that alongside the positive Phase 2b ATTUNE trial include a single additional Phase 3 trial. The meeting on June 26 was centered around the design of the Phase 3 trial that if successful may enable review of the NDA submission. The company plans to submit the full Phase 3 protocol for FDA review prior to trial initiation and is finalizing the full study protocol and anticipates beginning the Phase 3 program in PTSD in Q4.
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