Further, to support approval for the pediatric indication, we are currently generating additional data using the IL-2R alpha inhibition potency assay which was in place during the pediatric Phase 3 trial to provide the needed link assuring consistency between the RYONCIL product that was used in the pediatric Phase 3 trial and available commercial inventory.In parallel with the additional assay work needed for refiling, Mesoblast plans to conduct a targeted study in adults who are refractory to both corticosteroids and a second line agent such as ruxolitinib, for whom there are no approved therapies
AGM.
Aloha.
banter and General Discussion, page-8804
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