One major advantage that Mesoblast has in their pursuit of approval for Remestemcel-L in the US is the continued and growing use of Temcell in Japan for the treatment of acute graft-versus-host disease in both children and adults (acute GVHD).
The product was approved in September 2015 as Japan’s first allogeneic regenerative medical product and launched in February 2016.
Other products looking for approval don't have that luxury of confirmatory data.
Huge Plus!
Cell Therapy News/Articles, page-777
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