RE:RE:RE:RE:RE:How does Accelerated Approval work ONCY is set to run 2 trials in 1 in their planned adaptive designed180-200 Phase2b -> Confirmatory clinical trial - (a pivotal accelerated approval trial powered to a surrogate endpoint and a confirmatory regular approval trial powered to a clinical endpoint)
“Life Years Gained From the FDA Accelerated Approval Program in Oncology: A Portfolio Model,”
In the absence of accelerated approval, manufacturers instead likely conduct a single pivotal trial powered to a clinical endpoint or more well-established surrogate measure (as FDA usually accepts for regular approval), rather than 2 trials (a pivotal accelerated approval trial powered to a surrogate endpoint and a confirmatory regular approval trial powered to a clinical endpoint)