Intercept Pharmaceuticals, Inc. is hoping that a new analysis of the Phase III REGENERATE study of obeticholic acid (OCA) in non-alcoholic steatohepatitis (NASH) will pass muster with the US Food and Drug Administration when it resubmits its application, but analysts are uncertain that the data change the benefit/risk profile enough to warrant approval instead of another complete response letter (CRL).
Intercept announced on 7 July results of a new analysis of REGENERATE, based on a consensus panel method of reading...
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