@greyzone513 @Frankeng53 @LHF_EndDuchenne @RareCandace @icer_review Translation: "I don't know". FDA required a 2-year, controlled confirmatory trial. That trial, dubbed 'PROMOVI', is listed on https://t.co/ZY1J0YPbCr as having an actual completion date o
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$SRPT Phase 3 trial w/est May completion date NCT02255552: https://t.co/lAkGDKEffr Trial Tracker: https://t.co/aR7q5oJwjn
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@SarahKarlin @JacobPlieth There will never be a randomized, controlled study of eteplirsen. Best you’ll get is PROMOVI study https://t.co/rxedrGj55o
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Oh, so PROMOVI not counting as confirmatory study? It says though on https://t.co/uQkHcP5pYd though: https://t.co/oPDcQDK3dg open-label the issue? oops $SRPT https://t.co/nH0PMvFost