Ann: Mesoblast Partners with BMT CTN on Adult SR-aGVHD Trial, page-148

In the last submission by MSB to FDA including data supporting consistently high survival in children with SR aGVhd who received Remestemcel L treatment. But FDA is knocking it down because they want consistent efficacy of the commercial product. FDA is ignoring the fact they don't have any other alternative to this treatment. Acute GVHD occurs in approximately 50 percent of patients who receive allogeneic BMT, Over 30,000 patients worldwide undergo Allogeneic BMT per year mainly for blood cancer. In Patients with severe form of aGVHd moratality rate is 90percent.

Ryoncil has significantly greater OR in high risk children and adults with the most severe disease stages . Found this on Biospace.com published on 25 May 2020.

I am not sure consistent efficacy of the treatment is important for FDA or saving some human lives until new treatmen or alternative treatment is available?

These procedures are already being used in Canada , Newzeland and Japan.