the FDA’s conclusion and position is that they could not find any relationship between TNF1 and clinical outcomes.
And you could insert production assays for the steroids used on pediatric aGVHD and reach the same conclusion.Just because you give one patient a steroid of x potency does not guarantee y outcome in all patients.
I find it difficult to accept that line of reasoning, that all patients must respond the same to the same medication. Unless of course it is the TNF1 measure of potency they are calling into question, in which case there is something wrong with how the steroids used for pediatric aGVHD are measured too.
FDA ODAC Meeting Material discussion analysis, page-365
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