My interpretation is that the FDA are not convinced the disease is different in children vs adults.
Rux (current standard of care) is not offered to children on safety concerns, not lack of efficacy.
This is something the FDA has obviously made an internal decision on. That is why the FDA briefing notes were so important and was the red flag we all decided to overlook due to an overwhelming ODAC decision. Me included.
this will complicate their accelerated approval submission IMO.
MSB to dispute FDA finding in Type A meeting, page-213
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