NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

After reading the last 200+ posts I believe that certain things should be becoming clear to all. One is that in the two phase UK process, if at the end of Phase 1 there is no information being requested, the process simply moves into Phase 2 with no delay. The other is that inspections are not mandatory, but may be done as determined necessary.

In that all manufacturing of commercial products for the UK is at the Sawston facility utilizing manual techniques, the facility was previously inspected and accepted. Since that time I believe additional suites have been added, while they should duplicate the previously approved suites, I could understand if an inspection is made of those suites.

I believe it's also clear from LG's presentation yesterday that they're working on a larger cleanroom to house a large quantity of EDEN devices. As I understand it, the small cleanrooms being used for manual production can each accommodate ten EDEN units when they're approved, but that doesn't have anything to do with the approval and any current inspections.

In short, it's up to the UK authorities if they even want to do inspections, and if they do it should be just to verify that the facility they approved previously has essentially been duplicated in the additional cleanroom suites. If this is the case, I doubt if it will take inspectors more than a day to inspect the Sawston facility.

Gary