YES, this is a key observation. This entire exercise was about getting a product out into the CHILDRENS space....only AFTER that was all achieved, was the adult space to be looked at ie, a trial commenced - MSB itself always said yes to this approach - the FDA AGREED!
I'd rather see us appeal/court case the matter frankly - surely the head of the FDA overall can review this nonsense?
Ann: Update on BLA for Graft Versus Host Disease, page-186
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