Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-848

I do think that the elephant in the room regarding the change in the FDA attitude is the introduction of Philip Krauss who is so respected by everybody after what he did at the FDA and MD he probably resigned over the whole vaccines issue and he’s been proved right on that I followed this thing more than we’ve imagined but this is most exciting time we’ve got, indeed the whole size of the market now is so much larger than what it was three or four years ago and we do have a real real chance this time of having approval for adult GHD it works in Japan so why on earth doesn’t work in America? Is that complete American exceptionalism?