Cell Therapeutics (CTIC) announced today that it has completed the submission of its NDA for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin’s lymphoma (NHL). CTIC requested priority review, which if granted, would lead to a decision date on or around December 24, 2009.

As Xconomy says, the submission comes just in the “nick of time,” one week after CTIC announced it had eliminated approximately $52.9 million (or about half) of its debt through its note offering.

CEO Jim Bianco said this:

“This is a major milestone for CTI and is the cornerstone of a turnaround strategy for us in meeting our goals of becoming a profitable operating business. With more than 76,000 pages and 500,000 hyperlinks this submission represents the hard work of many CTI employees dedicated to making a difference in the lives of patients with cancer. This also represents a significant advance in the treatment of patients with relapsed/refractory aggressive NHL, a patient population which the FDA has acknowledged represents an unmet medical need.”

On the Opaxio side, we have not heard back from CTIC regarding any updates on a potential EMEA ruling, although we have reached out to management to get any new info.

Additionally, after much anticipation, our promised Opaxio write-up will be coming this Sunday, just in time for July.

Finally, if you’re new to IguanaBio or the CTIC story, you can check out every post we’ve ever done on the company right here.

Stay tuned…

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