“Our request to meet with the FDA to propose an amendment to our ongoing VERSATILE-003 Phase 3 trial represents the culmination of the encouraging data from our now completed VERSATILE-002 trial”, said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We believe the positive PFS data offers an important opportunity to shorten the trial duration and time to regulatory submission while maintaining mOS as the endpoint for full FDA approval. Importantly, we believe this approach may also accelerate the availability of this promising treatment to patients in need.”
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