Oncolytics Biotech Inc T.ONC

Alternate Symbol(s): ONCY

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 25, 2023 6:00pm

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Post# 35360584

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

Aside of any candies and nuts, the fact is that any of the Phase 3s/AAs will be sized and powered to the degree that is sufficient to achieve statistical significance for the FDA's approval. Whether that size is a 200 patient biomarker driven size or some other plus or minus number, what matters is that the FDA will be involved in agreeing to the patient size of this "one-trial" approach to reaching full approval.

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