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PTC fails to convince FDA adcom that Translarna merits approval

By Michael Fitzhugh
Staff Writer

Thursday, September 28, 2017

PTC Therapeutics Inc.'s bid to convince members of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee that it should recommend approval of DMD drug Translarna failed on Thursday, with 10 out of 11 members agreeing that, although it's possible the drug may be effective, the data are inconclusive and more work needs to be done.

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