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Subsequent events | 12 Months Ended
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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.

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- Definition The entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business. + References No definition available. + Details
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