conjecture only, but don’t think they will be going for AA for paediatric SR-aGVHD , rather if the FDA agree the potency assay they recently presented it should be included in another BLA for pediatric only. Or wait until the adult is done, and get both adult and paediatric both at once.
I think the former, as it’s a quicker pathway.
the two AA’s I’m referring to are HF LVAD and HLHS for (which comes with a voucher if approved).
conjecture only, but don’t think they will be going for AA for...
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