It's because they're worried they will spend all that money and effort and it will show the cells don't work.
The original trial in adults showed no efficacy - that was a large RCT.
It was only in post hoc subgroup analysis that they found efficacy in kids.
Of course they're worried about running another trial. Look how all of their trials have gone. Maybe the cells just don't work.
The FDA spelled it out to them twice. Why else would they not have done it?
Flow or Flaw or Slow, page-10
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