PTC receives refuse to file letter from FDA for Translarna (ataluren)

23 February 2016 - The FDA states in the Refuse to File letter that the application was not sufficiently complete to permit a substantive review. PTC first learned of the Refuse to File decision via this letter and is reviewing its content to determine the appropriate next steps.

For more details, go to: http://ir.ptcbio.com/releasedetail.cfm?ReleaseID=956451

Michael Wonder

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Michael Wonder

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Outcome , US , Orphan drug , Submission