[color=red]Based on the results in this Phase 3 study (ANAVEX®2-73-RS-002)[3] and the prior successful U.S. Phase 2 (ANAVEX®2-73-RS-001)[4] study in adult patients with Rett syndrome, Anavex is planning to meet with FDA to discuss the approval pathway. [/color]There are no FDA-approved drugs for Rett syndrome. ANAVEX®2-73 has Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome and may be considered for accelerated approval.