Ann: Update on Novartis Agreement, page-599

"that October, the FDA issued a complete response letter for the same candidate in a different indication, pediatric acute graft-versus-host disease, over issues with trial design. Mesoblast had submitted its application on the basis of one single-arm, open-label study rather than a randomized trial, even though the drug demonstrated a statistically significant benefit in its primary endpoint against the historical control rate."

have to be remember..... well atleast the FDA should they advised and agreed with the single arm. and as said by many here ...the FDA changed the goal posts after admin stuff ups