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Mesoblast Ltd Reaches Key Manufacturing Agreement With The United States Food and Drug Administration

Monday, 19 Nov 2012 05:32pm EST 

Mesoblast Ltd announced that it has reached agreement with the United States Food and Drug Administration (FDA) on the manufacturing process to supply its mesenchymal precursor cells (MPC) for Phase 3 clinical trials. In addition, it has established with the FDA a clear pathway for commercial manufacturing supply of its cell therapy products. The agreement was based on acceptance by the FDA of comparability data from Mesoblast's initial set of manufacturing runs for clinical product to be used in the upcoming Phase 3 trial for congestive heart failure. The agreement with the FDA on Mesoblast's manufacturing process applies to supply of MPCs in Phase 3 trials for additional indications. 

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