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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

Post by Quentin30on Apr 11, 2024 9:05am
492 Views
Post# 35982946

Type C Meeting Timings

Type C Meeting TimingsTimings for Type C meetings are such that the request for the meeting must be sent 75 days prior to the meeting date.

So, we're looking at 24th June for the FDA's repsonse.. Presumably ONCY has disclosed its plan for its long awaited Phase III and wants the FDA 's blessing on several points.

If feedback is positive (and/or aligned with the answers ONCY was seeking), then ONCY and partner will start the process of preparing and submitting the Phase III clinical trial protocol.

The timings suggest to me that any Phase III might just start in Q4 2024, but more likely in 2025.



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