“Our interactions with the FDA have been highly collaborative and constructive, providing us with clear guidance to help inform our Phase 3 development plans,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We are in alignment as to necessary key pivotal trial design features and Phase 3 clinical outcomes needed to support a NDA filing. We look forward to continue working closely with FDA on our Brilacidin oral rinse program as we prepare to enter the pivotal stage of clinical evaluation.”
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