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 7:46pm

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Post# 35359786

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

Trial size is of no issue should the FDA grant an accelerated approval (AA) and as ONCY's acquirer taking on the responsibility of a "one-trial approach" to FULL APPROVAL.

All this means is that ONCY has 2 Phase 3 ready clinical trials "in the hopper" ready for Big Pharma to take through to FULL APPROVAL by means of today's guidance by the FDA.

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