Additional Relevant Details A complex perianal fistula consists of abnormal tracts between the rectum and the skin surface near the anus, and is commonly associated with Crohn’s disease. It is a serious clinical condition leading to pain, discharge and that can cause severe incontinence. Complex perianal fistulas are associated with depression and may constitute a risk for anorectal carcinoma. Up to 120,000 adult Crohn’s disease patients in Europe and the United States may eventually benefit from Cx601 in an indication for which there is no alternative satisfactory treatment. “The submission of this application to the EMA represents another important achievement in TiGenix efforts to bring Cx601 to those Crohn’s disease patients who currently lack an effective treatment for this serious and debilitating condition,” said María Pascual, VP Regulatory Affairs of TiGenix. “Meeting this milestone brings us one step closer to fulfilling our ultimate goal of making our therapy available to European patients in the second half of 2017.”