Maybe, but I don't agree with the need to wait for the adult trial to be completed. Commence yes, but not completed.
In this case, AA involves a commitment to perform a full trial i.e. the conditional approval can be pulled if the trial stops or the results are not good enough.
Ryoncil is & was close to full approval.
This commitment to do the adult trial could be enough for an AA for paediatric - we’ll see
banter and General Discussion, page-9206
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