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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

Post by Noteableon Feb 10, 2022 4:34pm
216 Views
Post# 34418144

FDA Guidance on Adverse Reactions Section of Labeling

FDA Guidance on Adverse Reactions Section of LabelingSection IV. (D)

Avoiding Nonspecific Terms In characterizing overall adverse reaction experience, nonspecific terms that lack a commonly understood or precise meaning are discouraged, as use of such terms can be misleading. For example, the phrase well-tolerated is a vague and subjective judgment about a drug’s adverse reaction profile for which there are no commonly understood parameters. In addition, the terms rare, infrequent, and frequent do not provide meaningful information about the frequency of occurrence of adverse reactions.

https://www.fda.gov/media/72139/download

It would be much better if ONCY avoided using the term "well tolerated" in future press releases.


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