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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 > How does Accelerated Approval work
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Comment by Noteableon Jan 20, 2024 1:04pm
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Post# 35837398

RE:How does Accelerated Approval work

RE:How does Accelerated Approval work
Should read: 

How does Accelerated Approval Work in Rare/Orphan diseases?


" .... accelerated approval, which allows the use of surrogate endpoints that are not considered well established but that are determined to be “reasonably likely to predict clinical benefit.”  rules define surrogate endpoint as “a laboratory or physical sign that is used in therapeutic trials as a substitute for a clinically meaningful endpoint that is a direct measure of how a patient feels, functions, or survives and that is expected to predict the effect of the therapy” (57 Fed. Reg. 13234 at 13235; see also ). FDA then requires postapproval studies to develop further evidence about benefits and risks based on clinical outcomes."

https://www.ncbi.nlm.nih.gov/sites/books/NBK56185/


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