Bingo!
Does this necessarily require randomized clinical data? Not necessarily. But they need to need to somehow encourage the use of Rem-L with pediatrics so they can collect this data. It will be easier to encourage this use with an FDA approval rather than another expanded access trial.
1 Bold - ODAC meeting, it was explained why it's not a option
2 Bold - the money.
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-723
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