FDA meeting minutes confirm the previously disclosed End-of-Phase 2 outcomes and add further detail on the planned Phase 3 protocol. The update is largely procedural/confirmatory with no new efficacy/safety metrics or guidance, implying limited near-term repricing risk/benefit for the program.
FDA meeting minutes confirm the previously disclosed End-of-Phase 2 outcomes and add further detail on the planned Phase 3 protocol. The update is largely procedural/confirmatory with no new efficacy/safety metrics or guidance, implying limited near-term repricing risk/benefit for the program.
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