RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Stepped up their Corporate Presentation Game Accelerated approval is a feature of the whole NASH indication. It exists because drugs are approved based on Nash inflammation and fibrosis which ARE the surrogate endpoints. That is why every NASH company following this surrogate pathway has to commit to a long/large Ph4 based on the actual real clinical endpoints of all cause mortality/end stage liver outcomes/CV events.
You seem to be mixing accelerated approval with breakthrough designation.
It all about indication with surrogate endpoints, NASH is one of those indications.
All he's saying when he talks about accelerated approval is that they are following the NASH guidelines using the two Nash/fibrosis surrogate efficacy endpoints.
jfm1330 wrote: Since 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.