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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 4:41pm
111 Views
Post# 36034463

RE:RE:RE:RE:FDA MEETING

RE:RE:RE:RE:FDA MEETINGok, when the office of therapeutic products (otp) at the fda sent the decision to grant the type c meeting, that should have been accompanied with the meeting date.

that said and if that happened, then oncy is supposed to send a meeting package to the otp at least 47 days before the scheduled date of the meeting or wro (written request only).

the meeting is scheduled for 60 minutes.

if the meeting takes the form of a teleconference, then otc submits responses to questions in oncy's package ntl (no later than) 5 days before the scheduled meeting date and oncy is required to respond to the fda's preliminary response nlt 3 days after receipt of the fda's preliminary response.

all that said, oncy's timeline for submission of its meeting package is right about now +/- a week.

as to any obligation to inform shareholders as to any point along that timeline, i don't know.  seems anything along that timeline is somewhat administrative.  however, if given the green light i would think that would be material and would warrant a pr/nr

so, put a pin on your calendar for the end of june.
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