"The FDA has set a Prescription Drug User Fee Act(?PDUFA?) target action date of June 26, 2020for the completion of its review of our NDA seeking approval of OCA for liver fibrosis due to NASH. As a result of the uncertainties relating to the launch of OCA in liver fibrosis due to NASH and their potential impact on our 2020 financial performance, we are not providing 2020 net sales guidance."
Scheint heute nicht mein Tag zu sein. Eben erst AMRN und nun hier auch. Unerwartet und unschön, aber aufgeschoben ist ja bekanntlich nicht aufgehoben. Hoffe ich mal.... ;-)))
NEW YORK, May 22, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that based on discussions earlier this week, the U.S. Food and Drug Administration (FDA) has notified Intercept that its tentatively scheduled June 9, 2020 advisory committee meeting (AdCom) relating to the company?s new drug application (NDA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH) has been postponed. The postponement will accommodate the review of additional data requested by the FDA that the company intends to submit within the next week. The FDA has indicated that it will reach out to Intercept in the near future with a new proposed AdCom date. Intercept now anticipates that the FDA?s review of its NDA will extend beyond the Prescription Drug User Fee Act (PDUFA) target action date of June 26, 2020.