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
OS Therapies Incorporated
OS Therapies Incorporated OSTX | 0.00 |
- 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