i think the wait is because the design of the adult study will depend on whether approval is given for kids.
an accelerated approval or label extension study into adults will have different endpoints, timeframes etc when compared to a standalone adult trial.
im guessing they will want adults on the label as that will help support off label use into areas such as crohns, where there is already evidence and physicians that support its use.
2024 Here we go again., page-451
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