yes I'id imagine AA for pediatric only would be my guess and then once confirmatory trial is done (and if successful), the label extension could be given.
I never thought AA would be a potential outcome, but I could be wrong and would apprciate if anyone can find an example where someone lodged a BLA for full approval and instead walked out with an AA in that same review period. I haven't come across one, so that is just my take on it.
yes I'id imagine AA for pediatric only would be my guess and...
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