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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

Comment by Noteableon Mar 24, 2023 12:17pm
207 Views
Post# 35358802

RE:FDA guides on how AA can be converted to full approval.

RE:FDA guides on how AA can be converted to full approval.So when Matt stated that the trial design for the breast cancer Phase 3 clinical trial would include 200-300 patients - he would seem to have been informing us that  ..the trial sample size would be large enough to adequately power the detection of a clinically meaningful and statistically significant improvement in both the endpoints for accelerated approval (e.g., response rate) and verification of clinical benefit (e.g., PFS or OS) - as the FDA pointed out in its draft guidance released today.
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