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For the 3 stooges: Adam, Mathew, and John: the actual FDA requirements quoted."3095-1 In order to verify the clinical benefit of eteplirsen, conduct a 2-year randomized, double-blind, controlled trial of eteplirsen in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. Patients should be randomized to the approved dosage of eteplirsen (30 mg/kg weekly) or to a dosage that provides significantly higher exposure, e.g., 30 mg/kg daily. The primary endpoint will be the North Star Ambulatory Assessment. Draft Protocol Submission: 10/2016 Final Protocol Submission: 04/2017 Trial Completion: 11/2020 Final Report Submission: 05/2021 You should allow sufficient time for the Agency to review, provide feedback,..." https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206488Orig1s000ltr.pdf What a bunch of idiots. Embarrassing little court jesters dancing around like a bunch of giddy light-in-the-loafers ignoramuses who haven't got a clue as to what's going on in the real world of serious people. Amazing they don't ever just shut the fuck up let people assume they are not the fools that they really are. |
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