And maybe they've sorted the potency assay.
But that doesn't mean the previous trial is now sufficient. You would often need to validate that potency assay in a prospective rather than retrospective way - hence why I suspect they'll be relying on the adult trial for both paeds and adults.
MSB said in another announcement they would be linking the potency to the adult trial to validate.
I suspect FDA will require this. But maybe I'm wrong.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-298
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