The FDA has essentially just sentenced 33 children a month to death by delaying the approval.
I have no doubt approval will come as the product is clearly effective, its just a shame the bureaucracy of it all. SI did seem quite annoyed in his tone this morning on the webcast but also reiterated that he is confident that on the basis that there is no approved treatment for pediatric SR-GvHD and such a high mortality rate (~80%-90%), the FDA will conditionally approve with a post-approval randomised adult trial following the type A meeting discussing the CRL.
Ann: Update on BLA for Graft Versus Host Disease, page-341
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