we'll be smelling the roses soon., page-4

IS possible that we could have a start date for our retts trial very soon. Article below outlined it could take 60 days.and that was written 17 may. so shouldnt be far away...

http://www.biospace.com/news_story.aspx?StoryID=260735&full=1

SYDNEY, AUSTRALIA--(Marketwire - May 17, 2012) - Neuren Pharmaceuticals Limited (ASX: NEU) announced today that it held a pre-IND meeting with the FDA Division of Neurology Products to discuss clinical development plans for the study of its lead drug NNZ-2566 in the treatment of Rett Syndrome. The Company requested the meeting to seek input and guidance from the FDA for the first clinical trial in patients with Rett Syndrome. In addition to FDA staff, represented at the meeting were:


•The Blue Bird Circle Rett Center at Texas Children's Hospital and Baylor College of Medicine by Dr Daniel Glaze, Professor and Medical Director, and Dr Jeffrey Neul, Associate Professor and Assistant Medical Director
•Autism Therapeutics Ltd by Dr Mike Snape, Chief Scientific Officer
•The International Rett Syndrome Foundation by Dr Steven Kaminsky, Chief Science Officer
•Autism Speaks by Dr Joseph Horrigan, Assistant Vice President and Head of Medical Research; and
•Neuren by Larry Glass, CEO.
Commenting on the meeting, Neuren CEO Larry Glass said: "We feel that the meeting was very productive in that we were able to explore with the FDA key, substantive issues affecting our regulatory and clinical development strategy. This will provide clarity as we move forward to finalize the protocols, submit the IND and prepare for the first trials in patients. The scientific and medical insight provided by Drs Glaze and Neul, who will lead the initial clinical studies, contributed immeasurably to what we feel was a very positive meeting. We are particularly appreciative of the willingness of the International Rett Syndrome Foundation and Autism Speaks to attend the meeting as advocates for patients and families affected by Rett Syndrome."

Neuren plans to refine the clinical protocol and submit the IND within the next 60 days. Pending FDA review of the IND and completion of the ongoing Phase 1 trial of the NNZ-2566 oral formulation, we intend that this first Rett Syndrome trial will be initiated later this year. The initial trial will be designed to assess the safety and tolerability of NNZ-2566 in adolescent and adult Rett Syndrome patients and to obtain preliminary evidence of efficacy.