Crimes Against Humanity, page-18

You can't say for sure you know that's the FDA's position in the case of Ryoncil.

Speaking hypothetically about any product whose MOA is to respond to signals of peak inflammation, let's say that product was trialled in adults and didn't demonstrate efficacy, would you then conclude it was unlikely to be effective in children either?

I'd be grateful if you could also answer this question.

If you did conclude it wouldn't work in children, then you wouldn't be scientific at all because, in the absence of validated biomarkers, the adults might have had less severe inflammation (we know children are more prone to a hyperinflammatory response with higher fevers, rashes etc., as in MIS-C and HLH, and also in IBD), which therefore could have affected response.

Making paediatric approval dependent on adult results is nonsense. I believe Ryoncil's approval has been delayed precisely because it works so well and is so consistent. I suspect it's not Ryoncil that's on trial. I'll put forward my reasoning in another post.