NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I'll repeat again that you cannot apply until you have a commercial production facility that will be ready for inspection by the regulator. The company doesn't have any such facility until such time as the EDEN can be used to make the vaccine.

20 tiny cleanrooms in Sawston don't constitute such a facility, they're adequate to get the UK started, but not the US or other more populous places.

If I'm right about 20 cleanrooms, each one is capable of making roughly 50 batches a year. That's 1000 total patients that could be treated in one year. Currently according to Google there are over 300,000 new cases of GBM annually worldwide, 1000 is less than the rounding error. It may be enough to get the UK started, but demand should require the EDEN there very shortly as well.

Once we've learned when approval of the EDEN is anticipated we'll know when filing with other regulators might be anticipated.

I'm not saying EDEN approval must occur prior to filing. I'm saying that it must be approved by a few months into the process when inspector can check the commercial production facilities. Clearly the company would need to be practically certain of EDEN approval before filing with one or more regulator.

Gary