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FDA's Oncologic Drugs Advisory Committee to Review Resubmitted Pixantrone New Drug Application on February 9, 2012
Date:1/2/2012

D or other matters raised by the FDA's Division of Oncology Products 1 (DOP1), the OND and/or the FDA, that CTI's interpretation of the guidance provided by the OND, the DOP1 and/or the FDA may be different than the intent of the OND, the DOP1 and/or the FDA, that the OND, the DOP1 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 ODAC may not review the NDA on February 9, 2012, that CTI cannot guarantee that ODAC's review of the NDA will result in a favorable recommendation to the FDA, that the FDA may not follow ODAC's recommendation regarding the NDA, CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

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