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ADVENTRX Reviews Data Supporting Development Of ANX-188 In New Indications
Date:2/26/2013

acturing clinical trial material, completing manufacturing process development activities, and being subject to a "clinical hold"; the risk of suspension or termination of a clinical study, including due to lack of adequate funding or patient safety concerns; the potential for institutional review boards or the FDA or other regulatory agencies to require additional nonclinical and clinical studies prior to initiation of planned phase 2 clinical studies in any particular indication in which ADVENTRX determines to develop ANX-188, which likely would increase the total time and cost of development in the indication; the risk that clinical studies of ANX-188 are not successfully executed and/or do not successfully demonstrate its safety or efficacy; the risk that, even if clinical studies are successful, the FDA determines they are not sufficient to support a new drug application; the risk that even if clinical studies of ANX-188 in one indication are successful, clinical studies in another indication may not be successful; ADVENTRX's reliance on contract research organizations (CROs), contract manufacturing organizations (CMOs), and other third parties to assist in the conduct of important aspects of development of ANX-188, including clinical studies, and regulatory activities for ANX-188 and that such third parties may fail to perform as expected; ADVENTRX's ability to obtain additional funding on a timely basis or on acceptable terms, or at all; the potential for ADVENTRX to delay, reduce or discontinue current and/or planned development activities, including clinical studies, partner ANX-188 at inopportune times or pursue less expensive but higher-risk development paths if it is unable to raise sufficient additional capital as needed; the risk that the FDA does not grant marketing approval of ANX-188, on a timely basis, or at all; the risk that ADVENTRX is not able to adequately protect its intellectual property rights relating to the MAST platform and ANX-188 and p
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SOURCE ADVENTRX Pharmaceuticals, Inc.
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