The FDA has requested additional data from the company's clinical trial. Intercept's CEO expressed disappointment at the decision, saying the agency had not communicated that the drug, obeticholic acid, was not approvable.
The company said that the agency had requested additional data for obeticholic acid and thus pushed the upcoming advisory committee meeting back from June 9, thereby delaying its decision on approval, which had also been scheduled for June 26.
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