Mani, in that they announced an off site location where an existing cleanroom etc. meets their needs the timing and enlarging of the new cleanroom in Sawston shouldn't effect approval at all. In fact, if the EDEN were ready it could be deployed sooner in the facility the company identified. They've also identified a similar place in the US.
As I remember it, the current Sawston building was designed for the addition of two large cleanrooms atop the existing structure. I gathered they'd cost more than the new cleanroom at a nearby location and that's why it's being built first. Back when all these designs were originally done I don't believe that there was any thought about hub and spoke manufacturing, perhaps when everything is considered they may not need to construct all they planned for at one time.
Of course, if in time they gain support for treatment in other cancers they'll need to build far more cleanroom facilities, or perhaps contract with a CDMO that have much of the needed facilities all over the world. LP has liked the idea of having everything in NWBO's possession, I just don't know how far she can take that approach. If nearly everywhere adopt the hub and spoke production model, if the spokes can load up with several EDEN units' massive hubs may be unnecessary. Spoke activities won't be owned by the company and they'll certainly earn money by making the vaccine, storing and distributing it, but the company will be well rewarded and only need to maintain the EDEN's and supplying the disposable cassettes.
During my treatment at City of Hope I was once transported between buildings in a passage that was a few floors underground. Alongside the passages I noted some large cleanrooms which didn't appear to be terribly crowded. I don't know how many EDEN's could be installed there, but I have a feeling that City of Hope could support all of their anticipated patient load, and probably support other nearby facilities as well. Cancer is what COH concentrates on, I believe they'll happily act as a spoke if it's permitted here in the US.
Gary
Bullish
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