They are going to be extraordinarily hard pressed to find a pediatric specialist willing to carry out a placebo controlled trial on - children, when they already know the death rate of those on the best standard of care.
And that position has been held for something over a decade, that is why the EAP study began, but supply of prochymal/remestemcel-L/Ryoncil did not stop at the EAP trial. And yes remestemcel-L used to have a designation with 100 in it but I don't remember the rest.
If you want to understand how some of the present came to be understand some of the past, this is from a conference in Rome, posted May 6, 2016.
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-686
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