Ryoncil: ODAC/FDA Meeting Discussion, page-1092

Question arises: "If you could talk about the FDA approval which was approved for steroid refractory on the basis of a single arm trial, as you know there's one drug, ruxolitinib, which was approved and had only conducted a singular randomized clinical trial class and if there are lessons to learn from that case which can be drawn to this one?"

Dr Baird: "That was for a drug which had additional approvals and a much longer track record." (effectively dismisses question and ignores similarities in cases that both drugs evidence rests on one single arm study)

Questioner: "Just a follow-up, understand it was a different drug with a different background, but it strikes me as a similar case, both being based on one trial and it seems important that we are consistent in our approach"

Dr Baird: " ..." (She dodged the question).