Oncolytics Biotech Inc ONCY

Primary Symbol: T.ONC

Healthcare Biotechnology

Oncolytics Biotech Inc. is a clinical-stage biotechnology company. The Company is focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype turning cold tumors hot through innate and adaptive immune responses to treat a variety of cancers. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments. The Company’s primary focus is to advance its programs in hormone receptor-positive / human epidermal growth factor 2- negative (HR+/HER2-) metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma to registration-enabling clinical studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.

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Oncolytics Biotech Inc > FDA guides on how AA can be converted to full approval.

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Comment by Noteableon Mar 24, 2023 8:02pm

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Post# 35359801

RE:RE:RE:RE:RE:RE:RE:FDA guides on how AA can be converted to full approval.

With the FDA's guidance today, any focus on the size of a "one-trial" biomarker driven Phase 3/Accelerated Approval/Full Approval clinical trial is only relevant to powering the trial so that it can reach statitical significance, and the FDA seems now prepared to grant an Accelerated Approval allowing any product to be marketed, if all the parameters of a biomarker dirven "one-trial approach" are met. And from what we know ONCY's biomarker "Phase 3 ready" drug pelareorep is "ready" for inclusion under the FDA's the "one-trial approach" announced today..

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