It's a recommendation for a new study (randomized) that appears...

It's a recommendation for a new study (randomized) that appears to address the objections about a randomized one in children.

Children are not mini adults. They respond differently. And we're talking about a therapy that responds to the inflammatory milieu of the individual. Anyone who believes in the "gold standard" of the randomized, controlled study, should require a separate one in children and adults. It could never have been done in children. The FDA knew that.

Let's say you ran a successful trial in EEN in pediatric Crohn's Disease back in the 80s when it would likely be delivered via naso-gastric tube. It was single-arm because you didn't want to subject children to an invasive procedure and a difficult therapy (which requires them to temporarily give up eating) without giving them the actual treatment.

Let's say the FDA required further evidence of efficacy and asked for a randomized, controlled study in EEN in adults/or children with Crohn's Disease and you ran one in adults because it was more ethical and practicable and the study failed to show clear evidence of efficacy.

Would you then conclude EEN didn't work for Crohn's Disease?

I don't see how it's scientific to make approval for children contingent on adult data. Of course Ryoncil works. It's been used in an EAP for well over a decade. You didn't address my points on that.