The FDA notified VBL Therapeutics Ltd (NASDAQ: VBLT) that clearance of new VB-111 batches for use in the U.S. is currently pending, as review by the Chemistry, Manufacturing, and Controls (CMC) group is still ongoing.
VBL Therapeutics (NASDAQ:VBLT) today provided an update on its ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer.
The Company was
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VBL Therapeutics Ltd (NASDAQ:VBLT) has amended the primary endpoint in the OVAL Phase 3 registration-enabling study of VB-111 (ofranergene obadenovec) gene therapy for…
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