Question-and-Answer Session
Operator
(Operator instructions) We'll go first to Bill Tanner with Leerink Swann.
Bill Tanner – Leerink Swann
Thanks. Randy, just a few questions I guess on the Prochymal programs. First on the GvHD, can you just maybe put a little bit more detail on the anticipated calendar? I think it was last year that you guys mentioned potentially to start rolling BLA submission, perhaps in the first quarter and then complete the final module, obviously, after the last patient has gone off reg in the third quarter. So just maybe a little bit more detail on that. And then secondly, you also mentioned that this company had been in discussions with the FDA about broadening the expanded access program for adults, just curious, an update on that.
Randall Mills
So, with regards to Graft-versus-Host Disease, there are a couple of key points. So, you can expect an announcement in the first quarter, this quarter, about our submission of the first module of the Biological License Application. As you mentioned, that's going to occur under a rolling submission so, as modules are completed, they will go into FDA and they'll go into FDA without delay. We have been in constant communication with the Food and Drug Administration and they have told us that they are very interested in providing us as close to real-time feedback on those submissions. So we're really excited about that level of cooperation that we're getting.
With regards to timing, the last patient out of the first Phase III trial for steroid-refractory GvHD, which will be the first one we register off of, is right now scheduled for May 29. Once that last patient is out, there will be a process in which we will need to lock down the data at all the different sites. We enrolled patients in over 70 sites around the world, so be patient as we make sure we make sure we get the data locked down correctly.
Obviously, we're interested in doing this quickly, but most importantly, we're interested in doing it correctly. We've come now very far, 17 years, and we do not want to trip over the goal line. So, we're going to do what it takes to responsibly lock down that data as quickly as we can but, as I said, with emphasis on quality. I can't give you an exact time on how long that's going to take. I can just assure you it'll be as quick as we can do in a quality fashion. Once that's done, that will make for the final module of the Biological License Application in which that will go in, so it'll be sometime after May 29. It won't be right away. It takes a long time to – generally speaking, it takes a long time, several months, to lock a trial database of that size and particularly, with that many sites, but it'll be as quick as possible. After it goes in to the Food and Drug Administration, we really are on their clock. We will start the process by – along with the last module, will be the formal request for expedited priority review. We anticipate getting that, but that's not something that we can specifically ask for until the last module is in. If we get that, we would expect a review time of six months or less.
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