it may be out of their hands, if the FDA are still not happy with the potency assay, then the phase 3 trial they conducted will not be accepted under a full approval BLA or AA. The key difference between the two are the endpoints, they both need an adequate study.
if the study is not adequate, then it’s not getting approved by the FDA under any pathway.
so that is why I suggest that if the FDA conclude that there still is no appropriate potency assay, they are best to just conduct the adult one and get approval for both at the same time. Alternative would be to conduct a new adequate study for paediatrics. That doesn’t make sense for them to do if they already have an adult one almost ready to go.
it may be out of their hands, if the FDA are still not happy...
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