Statistically Significant Final 2-Yr OS Data from Ph 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent Pulmonary Metastatic Osteosarcoma Announced
“The continued outperformance in overall survival of OST-HER2 when compared with historical control is exactly what we were hoping for when we started the Company in 2018,” said Paul Romness, MPH, Chairman & CEO of OS Therapies. “We have had highly productive regulatory meetings with the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA), the United States (US) Food & Drug Administration (FDA) and the European Medicines Agency’s (EMA) Dutch rapporteur. Representatives of all three regulatory agencies, in various ways, indicated that overall survival may be an appropriate clinical endpoint to support a conditional marketing authorization, especially when supported with biomarker data. The rationale for overall survival combined with biomarkers is largely a result of the compelling data recently published in canine osteosarcoma by researchers at the University of Pennsylvania.”
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