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ADVENTRX Reports Third Quarter Financial Results
Date:11/8/2010

ne or ANX-514 if they receive regulatory approval; the potential for regulatory authorities to require additional preclinical work and/or clinical activities to support regulatory filings, including prior to the filing or the approval of the Exelbine NDA or an NDA for ANX-514, which activities may increase the cost and timeline to NDA filing or approval and negatively impact ADVENTRX's ability to raise additional capital or partner its lead product candidates; the potential that changes made in transferring the manufacturing process for Exelbine and/or ANX-514 may result in a lack of comparability between the commercial product and the material used in bioequivalence trials, and that FDA may require ADVENTRX to perform additional non-clinical or clinical studies; the risk the FDA will determine that Exelbine and Navelbine® and/or ANX-514 and Taxotere® are not bioequivalent, including as a result of performing bioequivalence analysis based on a patient population other than the population on which ADVENTRX based its analysis or determining that increased docetaxel blood-levels during and immediately following infusion are clinically relevant; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing Exelbine and/or ANX-514, including validating commercial manufacturing processes and manufacturers, as well as suppliers, and the potential for automatic injunctions regarding FDA approval of ANX-514; ADVENTRX's reliance on the performance of third parties to assist in the conduct of its bioequivalence trials, regulatory submissions, CMC activities and other important aspects of the Exelbine and ANX-514 development programs, including analysis of the ANX-514 bioequivalence trial data, and that such third parties may fail to perform as expected; uncertainty regarding additional product candidates ADVENTRX may seek to acquire and the costs associated with developing and seeking approval of any such product candidates; the potential f
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SOURCE ADVENTRX Pharmaceuticals, Inc.
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Related medicine technology :

1. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
2. ADVENTRX Announces Completion of Patient Enrollment in ANX-530 Marketing-Enabling Clinical Study
3. ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study
4. ADVENTRX Announces Completion of Patient Enrollment in Phase 2 Clinical Trial of CoFactor(R) for the Treatment of Advanced Breast Cancer
5. ADVENTRX to Present ANX-201 Preclinical Data at Keystone Symposia HIV Pathogenesis Conference
6. ADVENTRX to Present CoFactor Phase 2 Breast Cancer Data at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO)
7. ADVENTRX Announces ANX-530 Safety Data From Registrational Bioequivalence Clinical Study
8. ADVENTRX Presents CoFactor Data at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO)
9. ADVENTRX Announces CoFactor(R) Phase 2b Clinical Trial Overall Survival Results
10. ADVENTRX Announces Preliminary Response Rate Data From Discontinued Phase 3 Trial of CoFactor(R)
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