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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 > Type C Meeting Timings
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Comment by Quentin30on Apr 11, 2024 10:38am
102 Views
Post# 35983237

RE:RE:RE:Type C Meeting Timings

RE:RE:RE:Type C Meeting TimingsHaving to hold a Type C meeting means there are questions ONCY has that they wish addressing...

Yes, it probably is related to potential biomarkers, and whether or not FDA will accept ONCY's suggested biomarker... the text of the new release still states potential, and not CONFIRMED...

So, this Type C meeting isn't exactly the one we want to be in...as it would be quicker simply to get on with the Phase III trial design, as per their SPA issued by FDA 6 years ago...

AFTER the FDA has fed back its responses either verbally or electronically (a Type C meeting does not have to face to face), only then can they write their trial protocol, and send that for assessment.

SO, motormouth... Feedback will be due Jun 24th, and thereafter ONCY will submit its phase III trial protocol... so NO Phase III before Q4 2024.

Jeez... and I see the market has reacted accordingly to this fabulous news... down already...LOL



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