RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Stepped up their Corporate Presentation GameSince survival is not an endpoint like in cancer trials, I don't see what could be a surrogate endpoint in NASH. In the case of NASH an accelerated approval is more likely to be given based on interim analysis of the data by an independant panel that would be authorized to access the blinded data at some point during the trial.
scarlet1967 wrote: When studying a new drug, it can sometimes take many years to learn whether a drug actually provides a real effect on how a patient survives, feels, or functions. A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as “clinical benefit”. Mindful of the fact that it may take an extended period of time to measure a drug’s intended clinical benefit, in 1992 FDA instituted the Accelerated Approval regulations. These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. Using a surrogate endpoint enabled the FDA to approve these drugs faster.