I see what you're saying. I don't believe the particular point "..the drug was established in other diseases that shared similar pathophysiology as with aGVHD" sets any sort of precedent, but remestemcel-l has already received approval in Japan, NZ and Canada, so it technically has already been established in aGVHD.
Mesenchymal stem cells are also well characterised, well researched and well documented in the scientific literature. Their roles are well known and accepted in science. In contrast, this does not normally apply to pharmaceutical products which are new and where very little is known.
FDA ODAC Meeting Material discussion analysis, page-113
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