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Thursday, June 3, 2021

VBL Adds Progression Free Survival as Second Primary Endpoint in Ovarian Cancer Study

 

  • Second primary endpoint added following discussion with the U.S. Food and Drug Administration
  • Successfully meeting either PFS or OS primary endpoints expected to be sufficient for submitting a BLA for potential full FDA approval
  • PFS endpoint readout expected in 2022; BLA submission could be possible one year earlier than previously projected with OS endpoint alone
  • Clinical trial amendment reported in an OVAL Clinical Trial in Progress poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

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