NorthWest Biotherapeutics Inc (NWBO)

[Baxers]

I'm not in the indsutry but I sincerely doubt that the machine can be validated first off-site. These are high precision machines akin to something like a gear grinding machine in the CNC world. It is impossible to calibrate any CNC machine and then move it afterwards and expect the calibrated tolerance to remain unchanged. I see no difference with a Flaskworks machine and it's production parameters. Besides parameter tolerance, the validation will - I assume - also include cleanliness control too and as soon as a machine is moved anywhere it would no longer be safely contained in a cleanroom. Therefore cleaning procedures and recalibration would have to be done in the new location prior to validation/ revalidation.