FDA aligns with MHRA and EMA on adaptive design for Ph 3 trial for OST-HER2
“With alignment in hand with FDA on the most recent updates to the proposed adaptive design for the Phase 3 trial design reviewed with MHRA and EMA, we have overcome the key hurdle to initiating the Phase 3 in the U.K. and beyond.” said Paul Romness, MPH, Chairman & CEO of OS Therapies. “More importantly, now that MHRA has stepped up and volunteered to take the international lead with Project Orbis, we expect to be able to move expeditiously through the regulatory process in the U.K., U.S. and Europe.”
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