On August 2015, TiGenix received the FDA endorsement of a Special Protocol Assessment for a pivotal Phase III study for Biologics License Application in the U.S. Since the granting of the SPA, further confirmatory positive results have been obtained from the European Phase III study of Cx601 , the largest randomized study performed so far in Crohn’s disease patients with complex perianal fistulas. Subsequently, TiGenix submitted a Marketing Authorization Application to the European Medicines Agency in March 2016.