FDA Meeting Requested to Seek Expedited Approval Pathway for PDS0101 in HPV16-Positive Head and Neck Cancer
“The final survival results and durable clinical responses from our VERSATILE-002 trial are very exciting. It’s the first time that a trial in the recurrent/metastatic Head and Neck Cancer population has reported a mOS of almost 40 months,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “The fact that our Phase 3 study has mOS as its primary endpoint and PFS as a secondary endpoint inherently lengthens the duration of the trial. To shorten the trial duration, we believe a meeting with the FDA to discuss changes to the current trial protocol to include PFS as an earlier primary endpoint independent of mOS is warranted. We look forward to keeping all PDS Biotech stakeholders informed as our discussions with the FDA progress.”
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