Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that it has met with officials of the FDA's Office of New Drugs ("OND") in Maryland and presented its arguments supporting the Company's belief that the data contained in its New Drug Application ("NDA") 22-481 support the conclusion that pixantrone is effective for its planned use.
"We appreciate OND's consideration of our appeal. While we understand disputes of this type are a challenging process, we felt compelled to seek this review based on the PIX301 results and lack of approved therapies for these patients with an unmet medical need. CTI is committed to the advancement of pixantrone," said James A. Bianco, M.D., CEO of CTI.
At the meeting, the OND requested additional analyses from the PIX301 Phase III clinical study. CTI intends to submit the requested information and expects that this will reset the time period for OND to provide its decision on the appeal. CTI anticipates a decision in the second quarter of 2011.
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