OS Therapies Achieves FDA And UK MHRA Alignment On Design...

Confirmatory Phase 3 trial to commence prior to BLA grant under Accelerated Approval Program in the U.S. and Conditional MAA in the U.K., Europe and Australia
Patent pending pharmacodynamic response biomarker accepted as surrogate clinical efficacy endpoint
TGA and MHRA agree to allow utilization of remaining Phase 2b drug product for initiation of confirmatory Phase 3
FDA and EMA fully align with Company on Chemistry, Manufacturing and Controls (CMC)
Market access process initiated with UK NICE and EU JCA

OS Therapies Achieves FDA And UK MHRA Alignment On Design Of Its Pending Phase 3 Study Of OST-HER2 For Prevention Or Delay Of Recurrence In Fully Resected, Pulmonary Metastatic Osteosarcoma