It's accepted that the disease acts differently in adults verses children, but is the same disease, and that running another RCT in children, according to the investigational doctors is unethical.
So it's an ethical issue, and I think is why it says children and / or adults, and I would bet even if it was only adults, Ryoncil would be approved for children. However it was only a recommendation in order to gather more evidence, and MSB has gathered more evidence through other means - negating the need to conduct another trial to get more evidence.
Almost 100% they will conduct a post approval adult phase 3 or 4 in order to label expand. RCT blinded etc....
2023 The Final Countdown, page-1835
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