February 20, 2018 / 1:21 PM / 3 months ago

BRIEF-PTC Therapeutics Receives Formal Dispute Resolution Request Decision

Feb 20 (Reuters) - PTC Therapeutics Inc:

* PTC THERAPEUTICS RECEIVES FORMAL DISPUTE RESOLUTION REQUEST DECISION FROM THE FDA’S OFFICE OF NEW DRUGS

* PTC THERAPEUTICS INC - OFFICE OF NEW DRUGS OF U.S. FDA DENIED PTC’S APPEAL OF COMPLETE RESPONSE LETTER IN RELATION TO NDA FOR ATALUREN

* PTC THERAPEUTICS INC - OFFICE OF NEW DRUGS RECOMMENDED A POSSIBLE PATH FORWARD FOR ATALUREN NDA SUBMISSION BASED ON ACCELERATED APPROVAL PATHWAY

* PTC THERAPEUTICS- LETTER FROM OFFICE OF NEW DRUGS ADDS CO’S STUDY 041 COULD SERVE AS CONFIRMATORY POST-APPROVAL TRIAL NEEDED FOR ACCELERATED APPROVAL

* PTC THERAPEUTICS INC - PTC CURRENTLY INTENDS TO MAINTAIN PATIENTS IN U.S. CURRENTLY RECEIVING ATALUREN FOR NMDMD Source text for Eikon: Further company coverage:

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