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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 Noteableon Jun 11, 2024 10:39am
90 Views
Post# 36082661

RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings

RE:RE:RE:RE:RE:RE:RE:Type C Meeting TimingsType C FDA meetings are a "catch-all" category and include any meeting concerning the development and review of a product that does not fall within the scope of Types A or B. The FDA notes that it will attempt to schedule all Type C meetings within 75 days of receiving the written meeting request.
 
When requesting a Type C meeting, Sponsors can request a written response to their questions rather than an in-person meeting, videoconference, or teleconference. A Sponsor may request a face-to-face meeting, but the FDA may decide that only a written response is necessary.

The meeting package for a Type C meeting is due 47 days before the scheduled meeting date. For Type C meetings that are requested as early consultations on the use of a new surrogate endpoint to be used as the primary basis for product approval in a proposed context of use, the meeting package is due at the time of the meeting request.

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otp-type-c-meetings
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