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's Head of CBER wants faster approvals with SE/biomarkers

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Comment by Noteableon Aug 17, 2023 8:55am

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Post# 35592540

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:FDA's Head of CBER wants faster approvals with SE/biomarkers

fastrrack5 - if you cannot see the relevance of pelareorep receiving orphan drug status in a number if relevant indications that could receive Accelerated Approval under the FDA's Warp Speed program, then you are lost somewhere in the world of the 60's "Get Smart" comedy crowd.

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