As the nonalcoholic steatohepatitis (NASH) space continues to bustle, Wall Street watches, scanning the horizon for promising new approaches while handicapping the odds for proven approaches.
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).