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Subsequent events
12 Months Ended
Dec. 31, 2015
Subsequent events  
Subsequent events

 

16. Subsequent events

        On February 22, 2016, the Company received a Refuse to File letter from the United States Food and Drug Administration, or FDA. The letter stated that the New Drug Application, or NDA, submitted by the Company in December 2015 for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy was not sufficiently complete to permit a substantive review. The Company intends to engage in dialogue with the FDA to discuss and clarify the matters set forth in the letter and determine our best path forward.

        On February 29, 2016, the Company announced that the Company expects to delist Translarna from the German pharmacy ordering system.