Not wanting to play devils advocate here, but it did appear at face value, that MSB were not asking for a BLA for salvage therapy when they strolled in the door. It appeared that they changed the audience to under 18's, which do infact already have approved therapies. I don't know if ultimately this made a difference, but it does throw the " there is no approved treatment" out the window completely.
The evidence may well have been there as a salvage therapy if there was nothing else approved.... Hopefully in the new BLA they stick with the original under 12's who have no approved therapy, and then move out from there.
Cell Therapy News/Articles, page-13153
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