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March 17, 2014
08:50 EDTICPTIntercept says FDA has not reported concern over FLINT trial to company
Intercept said the FDA has not report any concern to the company regarding the FLINT trial. Intercept said the cardiovascular events in the FLINT trial brought to light by the company in its filing occurred over the course of the trial and the last of them occurred prior to Mid 2013, about seven months before the positive interim efficacy analysis lead to the decision to stop the FLINT treatment phase early. The company said that based on its understanding of the mechanism of action of OCA, its clinical safety experience with its drug, and the rates of cardiovascular morbidity and mortality it in NASH patients, particularly in those with Type II Diabetes and other cardiovascular risk factors, the company said it does not currently view the low incidence of the cardiovascular events reported in FLINT to be indicative of a safety signal. Comments from Intertecpt's Q4 earnings conference call.
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June 29, 2015
16:13 EDTICPTIntercept submits applications for marketing approval of Obeticholic Acid
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