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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 Jun 11, 2024 1:57pm
105 Views
Post# 36083154

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting TimingsAnd because I have to keep repeating myself  an Accelerated Approval/Subpart H –

Unlike Fast Track, Priority Review, Breakthrough, and RMAT which reduce FDA’s review time, Accelerated Approval shortens the Sponsor’s clinical development time – For serious conditions with a meaningful advantage over available therapy – Permits the use of a “surrogate endpoint” that is likely to predict clinical benefit (e.g., ORR, PFS, mOS, and tumor shrinkage)  (which ONCY has demonstrated in and spoken about multiple times)– Sponsors required to conduct post-marketing studies to confirm benefit (i.e., confirmatory trials) – FDCA § 506(c); 21 CFR 314.500 3
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