NIH says that Infliximab only has a complete response rate of 17% and that remestemcel-l has a response rate of 66% to 68%. They went on to say…Despite activity, variable manufacturing practices limited the use of MSCs, given inconsistent efficacy between manufactured batches of product. If Mesoblast can get this assay problem solved, they will have a clear winner. NIH also said that the aGvHD rate can be as high as 70% for Bone Marrow Transplants (BMT) patients. Not 50% that is commonly published. This is a serious problem that needs to be addressed. They suggested too that MSC might be used as a preventative treatment before the onset of aGvHD but needed more studies on that possibility.
Long stock and barrel.
Its happening just need to hang tough.
Aloha.
Ann: Mesoblast Type A Meeting with FDA, page-416
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