I certainly don't know, but I suspect that at some point, perhaps a year or more ago NWBO made a determination that it would not attempt to gain approval with a large number of clean rooms and committed to the FlaskWorks unit. At that point achieving a certifiable facility utilizing the FlaskWorks units became the critical path to approval. I suspect that at the same time they decided to push one facility, Sawston, to be first to be approved even if it wasn't of sufficient capacity to gain U.S. FDA approval. Once Sawston was approved I believe the reasoning would be that creating similar such facilities in the U.S. or elsewhere shouldn't be difficult provided that they're able to mass produce the FlaskWorks units and St. Gobain's is able to mass produce the disposable cassettes.
Until we know otherwise, I believe that CRL will still have a major role in production for North America and that they currently have facilities with all that's needed except for the FlaskWorks units themselves. Once the U.K. comes on line I believe it won't take that long to bring a similar facility on line here in the U.S.
In my discussion with DI he was clear that certain processes occurring in the FlaskWork required essentially the same time as when done in a cleanroom, other processes could be somewhat accelerated. As I understand it, a cleanroom takes something over 7 days even to produce a batch of DCVax-L. I suspect that if we assume it will take slightly under a week in the FlaskWorks unit we'll be about right. The big savings is in the manpower required to operate in a cleanroom can operate ten or more FlaskWork units and it can do so in a far less controlled environment. Finish and fill will be done with essentially the same equipment whether it's done in a FlaskWorks unit or cleanroom.
Gary
