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Oncolytics Biotech Inc T.ONC

Alternate Symbol(s):  ONCY

Oncolytics Biotech Inc. is a 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 phase 3 licensure-enabling 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 Dec 04, 2022 1:48pm
192 Views
Post# 35149603

RE:Fast Track + PR (CR) = Accelerated Approval

RE:Fast Track + PR (CR) = Accelerated ApprovalThe possibility of having an accelerated approval granted on the basis of the Phase 2 Goblet study results in pancreatic cancer is what I would strongly urge ONCY to pursue with the FDA  - which would subsequently be followed up with a post-marketing confirmatory study in 2023. Other Big Pharma companies have been granted similar approvals for their I/O products on lesser results.

ONCY is currently talking about a registration study in 2023.
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