Intercept Pharmaceuticals Inc. will need to resolve at least three things before its obeticholic acid can be approved and widely adopted for NASH. The company must settle on a Phase III trial design and address lipid abnormalities seen in Phase II testing - although based on the natural history of the disease, the latter may have been overblown by the general media. Postmarket, the task will be figuring out how to reach the large segment of undiagnosed NASH patients.

The company hopes to have lipid data by year end, and may be ready for Phase III in early 2015.