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BioWorld - Monday, June 8, 2026
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Home » Intercept watches adcom dates, PDUFAs slide by as it receives CRL for OCA in NASH
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Intercept watches adcom dates, PDUFAs slide by as it receives CRL for OCA in NASH

June 29, 2020
By Lee Landenberger
Toss a complete response letter (CRL) onto two missed PDUFA dates and a few adcoms that were discussed but never actualized to get an idea of where Intercept Pharmaceuticals Inc. now stands with its NDA for obeticholic acid (OCA) to treat fibrosis due to nonalcoholic steatohepatitis (NASH).
BioWorld Regulatory Gastrointestinal FDA

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