Could Postponement of Intercept’s Expected NASH Panel Impact Its PDUFA Date?
CDER’s postponing of meetings planned through the end of April likely means a later advisory committee date to review OCA in NASH. The US PDUFA date previously was pushed back to late June.
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The company said a planned 9 June advisory committee to review the NDA for obeticholic acid in NASH has been postponed a second time, which means OCA likely will not be approved by 26 June.
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
Coronavirus Update: More Companies Join Therapeutics Accelerator, FDA Delays AdCom For First NASH Drug
As the global number of COVID-19 cases exceeds 500,000 for the first time, more biopharma companies throw their weight behind Gates Foundation's drug-hunting initiative.