Cell Therapeutics Submits Day 120 Response for Pixantrone Marketing Authorization Application to European Medicines Agency

Cell Therapeutics, Inc. CTIC today announced that it has submitted its response to the Day 120 List of Outstanding Issues to the European Medicines Agency's Committee for Medicinal Products for Human Use in regards to CTI's Marketing Authorization Application for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma. With this submission, CTI expects to receive a CHMP opinion regarding approvability of pixantrone during the first quarter of 2012. In the United States, CTI expects to resubmit its New Drug Application for pixantrone to the U.S. Food and Drug Administration during the fourth quarter of 2011 and the FDA has indicated the NDA would receive a six month review resulting in a decision on approval of the NDA by the FDA in the United States as early as April 2012.
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