Following extensive talks with the FDA and European regulators, Intercept Pharmaceuticals Inc. has nailed down plans for a rigorous pivotal phase III study testing obeticholic acid (OCA), the company's lead candidate, in about 2,500 patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis, a population representing potentially more than 14 million patients in the U.S. alone.