ADVENTRX Pharmaceuticals Reports Third Quarter 2008 Financial Results and Busin...(risk that restructuring costs may be gre...)

Date:11/6/2008

risk that restructuring costs may be greater than anticipated and ADVENTRX's October 2008 workforce reduction and any future workforce and expense reductions may have an adverse impact on its business; the risk the FDA will determine that ANX-530 and Navelbine(R) are not bioequivalent, including as a result of performing pharmacokinetic equivalence analysis based a patient population other than the population on which we based our analysis; the risk that the on-going clinical study of ANX-514 does not demonstrate pharmacokinetic equivalence or bioequivalence; the risk of investigator bias in reporting adverse events as a result of the open-label nature of the ANX-530 bioequivalence clinical study, including bias that increased the reporting of adverse events associated with Navelbine and/or that decreased the reporting of adverse events associated with ANX-530; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing ANX-530 and ANX-514, including validating commercial manufacturers and suppliers and the potential for automatic injunctions regarding FDA approval of ANX-514; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings, including prior to the submission or the approval of an NDA for ANX-530 and ANX-514; the risk that the resignation of ADVENTRX's former Chief Executive Officer and President and/or leadership by a committee of executive officers will negatively impact the Company's ability to execute its business plan; the risk that the performance of third parties on whom the Company relies to conduct studies or evaluate the data, including clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities a
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SOURCE ADVENTRX Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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