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 > How does Accelerated Approval work

<< Previous

Bullboard Posts

Next >>

Comment by Noteableon Jul 20, 2024 1:37pm

105 Views

Post# 36141234

RE:RE:RE:RE:RE:RE:RE:How does Accelerated Approval work

List of : CDER Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint - As of March 31, 2024 - Total Approvals 310

https://www.fda.gov/media/151146/download?attachment

75% increase in FDA Accelerated Approvals based on a Surrogate Endpoint since December 03, 2022

https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approvals

<< Previous

Bullboard Posts

Next >>

Morning Market Outlook for Nov. 21, 2024