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Oncolytics Biotech Inc ONCY


Primary Symbol: T.ONC

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 itntdfon May 18, 2024 5:52pm
96 Views
Post# 36047545

RE:RE:Type C Meeting Timings

RE:RE:Type C Meeting Timingswould be happy if it is that quick.  however, the fda timelines for type c meeting is as follows:

oncy made request on/around april 11.  fda "required" to respond within 21 days of request for meeting.  actual meeting to take place within 75 days of oncy's request.

a date for the mtg seems to be between the 3rd and 4th week of june based on the following:

request on/around april 11.  not sure if fda actually received the request on that date but assuming they did, then their response was due on/around may 1.   oncy announced at the quarterly update around may 9/10 the fda had authorized a type c mtg.  don't know when oncy actually received the notice from the fda but based on the fda timeline it would have been sometime between may 1 and the quarterly mtg.  75 days from oncy's request would be on/around june 24 which is why it seems next week would be really fast.

as i said, hope you are correct but it does seem a bit optimistic based on the fda published timeline.
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