Oncolytics Biotech Inc T.ONC

RE:RE:RE:RE:RE:How does Accelerated Approval work

[Noteable]

" Accelerated approval (AA) targets candidates that are similar to those awarded BTD in terms of qualifying characteristics, such as aiming to treat serious conditions and providing improvements over current therapy. Most importantly, however, AA allows drugs to be approved using surrogate endpoints that are reasonably expected to predict clinical benefits. For example, for some cancer drugs, progression free survival (PFS) may be an effective surrogate endpoint that can be assessed instead of overall survival (OS), which may take much more time to determine, thus delaying the approval of a novel therapy for patients who have the potential to benefit. There is, however, reasonable room for error in extrapolating PFS findings to OS. Consequently, confirmatory trials such as phase 3 double-blind controlled trials are necessary to prove further the efficacy and safety of drugs that have been awarded accelerated approval. These trials must be carried out within a certain time window, after which, the drug may be withdrawn from the market if not determined to be acceptable."

https://www.sciencedirect.com/science/article/pii/S1359644621005729