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Cell Therapeutics to Re-submit Pixantrone NDA in Consideration for Accelerated Approval in Accordance with Guidance from FDA's Office of New Drugs
Date:5/2/2011

ffuse large NHL and/or other tumors as determined by the FDA and/or the EMA, whether alone or in combination with rituximab, 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 OND and/or the FDA, that CTI's interpretation of the guidance provided by the OND may be different than the intent of the OND, that the OND may change its guidance, that the PIX301 study may not be deemed successful, that a re-review of the pixantrone NDA may not be warranted and, if warranted, that 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 the FDA may not provide CTI with a meeting quickly, that CTI may not be able to provide satisfactory information in response to the FDA's Complete Response, that CTI may not be able to re-submit the pixantrone NDA quickly, 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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Lindsey Jesch Logan

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