On a conference call following the decision, Sage CEO Barry Greene said only that the companies are reviewing the feedback and evaluating next steps. Aug 4: Mesoblast will have to provide more data before the FDA may approve its BLA for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD)
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(PubMed) MacLennan SC, Wade FM, Forrest KM, Ratanayake PD, Fagan E, Antony J