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Oncolytics Biotech Inc T.ONC

Alternate Symbol(s):  ONCY

Healthcare Biotechnology
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

Oncolytics Biotech Inc > Accelerated Approval, surrogate endpoints, registration
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Comment by Azzak34on Apr 06, 2024 1:32pm
94 Views
Post# 35974917

RE:RE:RE:RE:RE:RE:RE:Accelerated Approval, surrogate endpoints, registration

RE:RE:RE:RE:RE:RE:RE:Accelerated Approval, surrogate endpoints, registration It's simply to allow us to apply for approval mid trial or when the prerequisite primary endpoints have been met, or look like they're going to be met. 

"Traditional" phase 3 could take 3-4 years, by which time our patent may be close to running out, giving us very little or no bargaining power regardless of results. 

With the licensure enabling we have more leeway to apply for AA as the data comes in. 
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