RE:RE:How does Accelerated Approval work The Accelerated Approval Process (AAP) does not use validated surrogate endpoints. It was designed to consider surrogate endpoints that meet a lower standard of being “reasonably likely to predict clinical benefit.”
The below referenced link outlines ONCY's novel biomaker/surrogate endpoint clinical results that qualify pelareorep for the Accelerated Approval Process involving a new surrogale endpoint that is capable of: "reasonably likely to predict clinical benefit".
" The FDA describes a reasonably likely surrogate endpoint as one with a “strong mechanistic and/or epidemiologic rationale such that an effect on the surrogate endpoint is expected to be correlated with an endpoint intended to assess clinical benefit in clinical trials, but without sufficient clinical data to show that it is a validated surrogate endpoint.” This is the only difference between a surrogate endpoint that is considered validated and one that is not validated but can be used for accelerated approval."
https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-inc?postid=36092881