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Oncolytics Biotech Inc T.ONC

Alternate Symbol(s):  ONCY

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 Jan 20, 2024 1:31pm
139 Views
Post# 35837421

RE:RE:RE:How does Accelerated Approval work

RE:RE:RE:How does Accelerated Approval work January 2024 -  FDA Unveils Groundbreaking Rare Disease Guidance Document

For drugs eligible to follow the Accelerated Approval pathway, a determination of safety and effectiveness may be made based not on measures of direct clinical benefit, but rather on one of two alternative endpoints: (1) a surrogate endpoint that is reasonably likely to predict clinical benefit; or (2) an intermediate clinical endpoint that is reasonably likely to predict clinical benefit. Use of such endpoints may enable the drug to be studied for a shorter treatment duration and receive Accelerated Approval based on these findings. Importantly, however, for products approved under the Accelerated Approval pathway, FDA requires post-approval studies designed to confirm clinical benefit, and, among other things, may withdraw an accelerated approval product from the market for failure to confirm clinical benefit. 

https://www.fda.gov/media/175253/download?attachment

 

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