Category Archives: International Rett syndrome Foundation

Until the Twelfth of September

Posted on September 12, 2022 by melelllan

Well, what a day it is. Five days earlier than expected, ACADIA announced that the FDA has accepted the application for Trofinetide! There’s a lot to go over in this announcement, so let’s cut to the chase! “SAN DIEGO–(BUSINESS WIRE)–Sep. … Continue reading →

Posted in Acadia, FDA, hope, International Rett syndrome Foundation, LAVENDER TRIAL, margaret brimble, Neuren Pharmaceuticals, Rett Syndrome, RSRT, Trail to a Texas Trial, Trofinetide, Trofinetide Phase III, Uncategorized | Tagged , | 5 Comments

Where do we go From Here? Part I

Posted on August 10, 2022 by melelllan

Last week, the International Rett syndrome Foundation (IRSF) held a webinar with Dr. Dominique Pichard, CSO, IRSF and Mr. James E. Valentine, Esq., HPM aptly named, “What Comes Next? The FDA Regulatory Process from NDA to FDA decision and beyond.” … Continue reading →

Posted in Acadia, clinicaltrials.gov, Dame Margaret Brimble, FDA, International Rett syndrome Foundation, Intrepid 2566, LAVENDER TRIAL, Neuren Pharmaceuticals, NNZ-2566, NNZ-2566 trial, orphan drug designation, Rett Research, Rett Syndrome, rettsyndrome.org, TBI, Trail to a Texas Trial, Trofinetide Pediatric trial, Trofinetide Phase III | Tagged , , , , , , , | Leave a comment