The regulatory approval to conduct CNS Pediatric study in Russia was received by GCT in under 60 days.
This Phase III study in children and young adults with a rare genetic mutation in the X-chromosome was awarded to GCT earlier this year. Study aims to recruit up to 20 patients with this rare and debilitating disease in Russia alone. GCT is responsible for the site management, providing the full service clinical operations support, logistics and regulatory services.
On average, regulatory approval in Russia may take 3 — 3,5 months. We look forward to the first site initiation for this significant and exciting project.