Intercept Pharmaceuticals Inc.'s obeticholic acid (OCA) application for approval in non-alcoholic steatohepatitis (NASH) faces two big review hurdles before the US Food and Drug Administration decides whether the drug can cross the approval finish line.
Will A US FDA Advisory Committee Be In Intercept's Future?
There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.
