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 > CG Oncology

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Comment by Noteableon Jan 26, 2024 10:32am

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Post# 35846947

RE:RE:RE:RE:RE:RE:RE:RE:CG Oncology

Statistical significance is not a requirement with an Accelerated Approval. .... only the use of surrogate endpoints. Surrogate endpoints are used when the endpoint of interest is too difficult and/or expensive to measure routinely and when they can define some other, more readily measurable, endpoint, that is sufficiently well correlated with the first to justify its use as a substitute.

Statistical significance comes into the picture with the post-approval confirmatory trial.

https://pubmed.ncbi.nlm.nih.gov/2727464/#:~:text=Investigators%20use%20a%20surrogate%20endpoint,its%20use%20as%20a%20substitute.

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