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Product Discovery & Development
What Intercept needs to resolve for obeticholic acid to deliver in NASH
Next in NASH
Monday, January 20, 2014
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.
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