FDA Regulator Defends Controversial Decision to OK Sarepta Drug

Nov 17, 2016, 11:52 by Michael Croft

BostonGlobe.com | The nation's top drug reviewer Wednesday criticized Sarepta Therapeutics Inc.'s program to develop the first drug to treat Duchenne muscular dystrophy, saying the Cambridge biotech's clinical study involving a dozen patients -none of whom took a placebo for comparison purposes - "left so many questions."

November 17, 2016 | The nation's top drug reviewer Wednesday criticized Sarepta Therapeutics Inc.'s program to develop the first drug to treat Duchenne muscular dystrophy, saying the Cambridge biotech's clinical study involving a dozen patients -none of whom took a placebo for comparison purposes - "left so many questions." BostonGlobe.com