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Oncolytics Biotech Inc T.ONC

Alternate Symbol(s):  ONCY

Healthcare Biotechnology
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

Oncolytics Biotech Inc > Trials
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Comment by inthnoon Apr 05, 2024 9:22pm
170 Views
Post# 35974294

RE:RE:RE:RE:Trials

RE:RE:RE:RE:Trials
What is a registration enabling study?
 
Registration Enabling Trial means any Clinical Trial that is intended to, or does, generate data sufficient to enable the Filing of a Marketing Application in any country in the Territory.

I still do not think that AA is in the cards at this time as we would have heard by now and this is not information that the company can just hang on to and decide to let everyone know whenever they feel as this is a material event and has to be reported promptly. IMO

Having said that, to me registration enabling is the same as a phase 3 or trial that qualifies for marketing approval. Now hopefully we could get a clarification from the next fireside chat or cc that Matt does but I do not see that anything at this point has changed IMO of course.
 

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