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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 itntdfon May 10, 2024 10:42am
111 Views
Post# 36033491

RE:FDA MEETING

RE:FDA MEETINGthe fda guidelines state acceptance of request for a meeting will occur within 21 days of the request.  oncy made that request on or around april 12 and the meeting yesterday confirmed the fda granted the request (which apparently happened within that 21 day guideline).

fda guidelines state a meeting will be within 75 days from the requested date.  that means a meeting will occur within the next 6 weeks per the fda guideline.

the meeting can take one of three forms:  face to face, teleconference/videoconference, or written response only (wro).

based on the fda guidelines, there should be a meeting in one of the three designated formats by the end of june.
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