RE:RE:RE:How does Accelerated Approval work “The accelerated approval program may lower the operational hurdles for launching the above-mentioned products by allowing studies with surrogate endpoints to be reviewed for early approval, in which the sample size is smaller and the results are available more expeditiously than studies with true endpoints,” wrote Satoshi Kato and Shunsuke Ono, of the laboratory of pharmaceutical regulatory science at The University of Tokyo.
"Accelerated approval products were also often given other regulatory designations such as orphan drug (67%), priority review (55%), breakthrough therapy (36%), and fast track designations. Products that were deemed to have an acceptable benefit-risk profile were more likely to have another regulatory designation (89%) compared to products with a favorable benefit-risk profile (73%)", the researhcers wrote.
ONCY's pelareorep has orphan drug and fast=track designation.