In a damn­ing in­dict­ment, FDA re­view scorns PTC’s Duchenne drug for re­peat­ed fail­ures

PTC Ther­a­peu­tics $PTCT ex­ec team proved this week that they are glut­tons for pun­ish­ment.

Af­ter en­dur­ing two hu­mil­i­at­ing slap-downs at the FDA for their would-be Duchenne drug ataluren, the biotech — led by CEO Stu­art Peltz — has forced the agency’s hand, re­quir­ing a pan­el re­view on Thurs­day. And in the agency’s re­view of the drug, re­leased Tues­day morn­ing, the FDA went to con­sid­er­able lengths to ex­plain why they think this drug — pro­vid­ed an ac­cel­er­at­ed ap­proval in Eu­rope, where it’s sold to pa­tients as Translar­na — has re­peat­ed­ly proved to be un­wor­thy of an ap­proval.

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