Using preliminary evidence, rather than a full series of clinical trials, it’s possible that, in many cases, the supporting evidence for the product would be based on surrogate endpoints used to determine clinical efficacy (Accelerated Approval). This would require post...
Most importantly, however, AA allows drugs to be approved using surrogate endpoints that are reasonably expected to predict clinical benefits. For example, for some cancer drugs, progression free survival (PFS) may be an effective surrogate endpoint that can be assessed instead of overall survival ...
stated, “We are also pleased to announce that the MAESTRO-NASH trial in noncirrhotic NASH is now fully enrolled. Enrollment of the MAESTRO-NASH study was closed at approximately 1,750 patients based on the enrollment target of the 54...