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Independent Radiology Assessment Panel Results Confirm Statistical Significance of Response and Progression Endpoints of Cell Therapeutics' Pixantrone PIX301 Pivotal Trial
Date:9/27/2011

results and the market price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory NHL and/or other tumors as determined by the FDA and/or the European Medicines Agency, that accelerated approval by the FDA of pixantrone may not be possible or occur, that CTI may not be able to address satisfactorily the two key matters raised by the OND or other matters raised by the DODP, the OND and/or the FDA, that CTI's interpretation of the guidance provided by the OND, the DODP and/or the FDA may be different than the intent of the OND, the DODP and/or the FDA, that the OND, the DODP and/or the FDA may change its guidance, that the PIX301 study may not be deemed successful, that upon a re-review and/or resubmission of the NDA the FDA may find pixantrone to not be safe and/or effective, that the PIX301 study may still be deemed to be a failed study, that the FDA may require an additional clinical trial of pixantrone, that if CTI conducts an additional clinical trial, it may not demonstrate the safety and effectiveness of pixantrone, that CTI may not be able to provide satisfactory information in response to the FDA's Complete Response Letter, that CTI may not be able to re-submit the pixantrone NDA for accelerated approval as early as October 2011, that even if CTI resubmits the NDA for accelerated approval in October 2011 the FDA may not complete the review of the NDA within six months of resubmission, that CTI may not obtain an FDA action date by April 2012, that CTI may not obtain approval of the NDA from the FDA in the first half of 2012, CTI's ability to continue to raise capital as needed to fund its operations,
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SOURCE Cell Therapeutics, Inc.
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