Replies to post #799368 on NorthWest Biotherapeutics Inc (NWBO)

[iwasadiver]

The way it works is that the process gets verified as a Type II Variation to the the approved MA. Once that occurs any machine has to be validated. I’m not sure if it can be validated and shipped or has to be validated on each site. I believe the former but I haven’t dug into it that deeply. Either way it’s not a big deal and like any technology is built into lead times early.

[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.

[maverick_1]

Skitahoe: common sense says transportablity is a tertiary consideration and removed from these higher considerations:

Foremost is certification upon INITIAL installation.

Like most precision tools for medicine highly unlikely any institution would even VENTURE
for consideration when the costs of an EDEN unit is LOW versus the transport cost logistics & TANTAMOUNT are:
•the accuracy impinging on
•the quality &
•success of NWBO's DC VAX PLATFORM.
Moreover
•Unlikely any Regulatory Agency would approve given a potpourri of ensuing issues

So my view
Skitahoe's suggestion is DEAD on ARRIVAL

DIFFERENT STROKES for DIFFERENT FOLKS