Thursday, November 10, 2016 7:53:08 PM
Was just reading about the trial (no pun intended:)) and tribulations of PTC Therapeutics nonsense mutation Duchenne muscular dystrophy (nmDMD) drug and the FDAs Refuse to File Letter which means that the FDA won't review their NDA submission or have an Adcomm meeting to review it. Just wondering what was the FDAs point in accepting the Apaz NDA for review if they didn't think it had any merit. Just don't get that. Here's the reference to PTCTs dilemma
http://www.biospace.com/News/ptc-therapeutics-tanks-after-the-fda-denies-dmd/435813?type=email&source=GP_101716
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