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Oncolytics Biotech Inc ONCY


Primary Symbol: T.ONC

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.


TSX:ONC - Post by User

Comment by Noteableon Mar 25, 2023 10:49pm
169 Views
Post# 35360739

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

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:FDA guides on how AA can be converted to full approval.Under the new FDA guidance and the "one-trial approach, an accelerated approval would be sought alongside the registration of what would be considered a Phase 3/4 clinical study AND I would think that ONCY's potential Big Pharma would want to be responsible for such registration action as they would want to be responsible for the design, implemention and control of such a critical late stage clinical study. 

So I think of Big Pharma ultimately navigating the final registration steps for ONCY's breast and pancreatic cancer studies along with others that have been identified as potential winners for BP.


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