So, let's say MSB ran what you consider (or anyone else for that matter) a successful "proper' trial in adults, would you then agree that the product had demonstrated efficacy and should therefore be approved for children too?
I'd be grateful if you could answer this simple question.
If your answer is "yes", then how on earth can you consider that scientific? The cells respond to signals of inflammation in the individual, the more severe cases responding the best, which is demonstrated across the platform.
Children are not mini adults. They're immunologically different and tend to be more "stormy". It doesn't necessarily follow that efficacy in adults would apply to children, particularly for a therapy whose MOA is to respond to the inflammatory milieu of the patient. The FDA could have approved the product for children under certain conditions.
If sacrificing children for adults (if that isn't a metaphor for what's going on in this insane world, I don't know what is!), doesn't fit the definition of a crime against humanity in this case, at the very least it's heinous, especially in light of not revoking Ruxolitinib's approval in acute GvHD.
MSB Price at posting:
37.0¢ Sentiment: Hold Disclosure: Held
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