-- Oncolytics Biotech (ONCY) said Monday a meeting with the US Food and Drug Administration has led to agreement on how to design a trial to support approval of pelareorep for patients with unresectable metastatic squamous cell carcinoma of the anal canal.
The company added that it will use the regulator's feedback to finalize the study plan. The trial is expected to be a single randomized controlled study that could support both accelerated approval and full approval at different stages, the company said.
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