Hi
@Phaedrus, have you applied your wondrous mind to how fast an approval could come for Adult SR aGvHD, given the voicing of accelerating approval processes by the new FDA Department Heads? Given real world evidence exists for ( presumably) salvage patients?
A single open label phase 2 trial with 28 day response , maybe 56 day in total. Product is verified as the same used in kids via potency assays, dosing is the same per kilo, safety same- manufacturing approved.
I'm bullish here- best part of the announcement as I far as I am concerned.
Ruxolitinib - which doesn't work in Grade3/4 - was granted Accelerated Approval on n=71 patients.
If we take on Rux Refractory- 6 month trial- rolling review- surely we are a shot at AA for Rux Refractory- aka unmet need.
Reg
(20min delay)