“What I'm saying here is that it might be possible to bring on a speedy adult population AA with FDA's consent & at the same time use the process of settling the confirmatory trial design to sort out the remaining adult trial issues between MSB, BMT CTN and the FDA.”
“How quickly could we then hope to file a BLA for AA for the RR-aGVHD adult population? If this kind of RWE is what the FDA wants to use to demonstrate rapid approvals, then I expect it would be toward the end of this year i.e. just as Ruxolitinib's patent cliff issues start to swing into view.”
So according to your inferences,
@Phaedrus, the company could very well go straight to talking about an AA for the adult RR-aGVHD population at the upcoming meeting with the FDA in early July. Rux’ patent cliff would be icing on the cake if the FDA were to guide the company towards a filing for AA, with the hoped for AA filing being done around the same time, just when Incyte would be under some pressure anyway, AND when physicians might start revisiting some of their assumptions re Rux’ effectiveness in the 44% of the population that it fails.
Remind me, how much bigger is the adult market compared to the kids’ market?
(20min delay)