Doing an adult trial, will not, should not affect the data of the paeds.
The only data that is relevant is the Potency assay.
(Yes, this can be interchanged between the adults and Paeds. Which is what the FDA want this time around)
As for last time FDA suggesting the adult trial, I do not believe they would have given approval for Paeds based on an adult trial.
Given the high potential of immunological recovery in children and not comprehending the age-dependent control of the developing immune system is why they chose not to do an Adult trial.
Its about recovery from all the other therapies. Paeds respond better overall. Simple as that
Ann: Trading Halt, page-625
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