Oncolytics Biotech Inc ONCY

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

[Noteable]

As previously posted :  Accelerated Approval provides for a drug to receive a conditional FDA marketing approval based on surrogate endpoints that have demonstrated a clinical benefit, An Accelerated Approval is granted well before a Registrational BLA is filed, and an AA requires the sponsor to run a confirmatory clinical trial on which the FDA decides to grant full marketing approval. The FDA's full marketing approval follows the sponsor registering (filing) a Biological Licensing Application (BLA) on the final results of the confirmatory / registration enabling clinical trial.

Registration Enabling Clinical Trial means (a) a hyman clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c), as amemded, and is intended to (i) establish that the productis safe and efficacious for its intended use, (ii) define contraindications, warnings, precautions and adverse reactions that are associate with the product in the dosage range to be prescribed, and (iii) support Regulatory Approval for such product, or (b) a similar clinical study prescribed by the relevant Regulatory authorities in a country other than the United States.