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Friday, 05/22/2020 8:50:18 AM

Friday, May 22, 2020 8:50:18 AM

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ICPT—(-14%/PM)—FDA postpones 6/9/20 advisory panel—extends 6/26/20 PDUFA for NASH NDA to unspecified date:

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.

The PDUFA date for this NDA had already been postponed once when the original advisory panel was scheduled on 4/22/20 (#msg-152773679). I remain negative on the outcome (#msg-152659994).

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