Received FDA Type A meeting minutes related to previously announced clinical hold
FDA acknowledged newly developed in vitro assays of human plasma coagulation and tissue factor expression qualitatively differentiate ZGN-1061
Company is working with FDA to translate in vitro data and confirm relevant safety margins in an in vivo model
Additionally, Zafgen is exploring a second IND for ZGN-1061 in a population with higher unmet medical need
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