NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I may have been misinformed, but I was of the belief that the FDA and others actually raise the quality requirements for commercial products above what's used in Phase 3, unless that quality is shown to have been obtained for the Phase 3. I don't know that the units that manufactured for Phase 3 would automatically be acceptable, though I would expect that they would be.

I can't agree with you that Sawston can carry the entire initial demand, I believe that Sawston will be used for Europe, but I believe that CRL will be used for the ROW, which would immediately include the U.S. if the regulators are working together and announce approval by all at the same time.

I do believe that both will look to license the FlaskWork device as soon as it's authorized, but even then, I would suspect that the facilities where it's being used in will require approvals prior to converting from individual clean rooms to the FlaskWork device for production. Of course we'd have a total game changer if the FlaskWork device was approve prior to product approval with sufficient time to qualify production by FlaskWork.

I've got to believe that the Sawston facility is being built with the thought of converting to FlaskWork device at some point. I doubt that the Cognant based facilities that now are CRL were, the FlaskWork device wasn't in existence when those facilities were built. I would think that a number of FlaskWork devices can be used in every clean room, but no doubt power and environmental changes may be necessary.

I would suspect that totally new facilities built for the FlaskWork devices may be substantially less complex to build than converting clean rooms to the devices. It will be up to the regulators to determine how the FlaskWork units may be deployed. I don't believe the need the full clean room approach, but no doubt they will need to be reasonably sanitary. While a FlaskWork device might work fine in your kitchen, the regulators aren't about to let it do so, facilities will have to meet their requirements.

Gary