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European Commission Designates MST-188 As An Orphan Medicinal Product
Date:3/25/2013

velopment within the U.S.; the potential for significant delays in the development of MST-188, including as a result of delays in the commencement or completion of clinical studies, including due to difficulties in obtaining regulatory agency agreement on clinical development plans or clinical study design, opening trial sites, enrolling study subjects, manufacturing sufficient quantities of clinical trial material, completing necessary manufacturing process development activities, and being subject to a "clinical hold," or 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, the EMA or other regulatory agencies to require additional nonclinical or clinical studies prior to initiation of planned phase 2 clinical studies of MST-188 in any particular indication in which the Company determines to develop MST-188, including acute limb ischemia, which likely would increase the total time and cost of development in the indication; the risk that clinical studies of MST-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, the EMA or other regulatory agencies may determine they are not sufficient to support a new drug application; the risk that even if clinical studies of MST-188 in one indication are successful, clinical studies in another indication may not be successful; the potential for unsuccessful nonclinical or clinical studies in one indication or by a future partner that may be outside of the Company's control to adversely affect opportunities for MST-188 in other indications or jurisdictions; the Company's reliance on contract research organizations (CROs), contract manufacturing organizations (CMOs), and other third parties to assist in the conduct of important aspects of MST-188's development, including clinical studies and regulatory
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SOURCE Mast Therapeutics, Inc.
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