FDA decision within 1-50 days, page-22

http://hotcopper.com.au/threads/201....2435241/page-8?post_id=14547108#.VLGdH8scSsE

Above are HC links to 3 who consider additional trials will be needed before BT is granted.

Steve Kaminsky the CSO of Rettsyndrome.org

Dr Alan Percy, Professor of Pediatrics, Neurology, Neurobiology, Genetics, and Psychology at the University of Alabama in Birmingham, was an investigator for the Neuren Retts study.

Dr Michael Tranfaglia medical director who is from Fraxa

To this I add a 4th.

"If the results of the Phase 2 trial are positive, we intend to request an end of Phase 2 meeting with FDA to discuss requirements for a pivotal trial and registration under provisions of Fast Track and potentially Breakthrough Therapy designation. We are expecting that a pivotal trial would be same size as the Phase 2 trial and could be completed within one year."


Larry Glass
20 May 2013