NorthWest Biotherapeutics Inc (NWBO)

[DJPele]

This is wrong.

The GMP units won't even be in production until NWBO starts the build out for the Grade C labs. Only then will qualification and validation occur, AND ONLY THEN will they submit to the regulators.

From the 10K:

Production of the GMP-grade units will be timed to coincide with the timing for buildout of Grade C labs in the Sawston facility. When the GMP-grade units are delivered, Advent BioServices will undertake qualification and validation of those units, conduct engineering runs and collect data, and apply to regulators for approval to use the system to produce DCVax-L for patients.

Again, from the 10K regarding the Grade C Labs:

Simplified Grade C Lab in the Sawston Facility. The Sawston facility current has two Grade B labs. Such labs are required to be used for any manufacturing process that involves any open steps (i.e., open to the air). Grade C labs are much less expensive to operate, and allow multiple patients’ products to be manufactured at the same time in the same lab, but may only be used with closed systems. The Flaskworks system is closed and suitable for Grade C labs. The design and engineering works were previously completed for two Grade C labs, but the buildout will require substantial capital. Since the Company believes it will have adequate capacity for initial possible commercialization with the two Grade B labs, the Company has held off on raising and using the capital required to build the two Grade C labs. Meanwhile, Advent has devised plans for a simplified initial Grade C lab adjacent to one of the Grade B labs, making use of existing shell space and drawing upon some of the infrastructure associated with the Grade B lab. The simplified Grade C lab can be completed for a fraction of the cost and less than half the time for the regular Grade C labs. The Company anticipates potentially proceeding with this in the coming months when appropriate.

I feel like I am talking to a brick wall about this specific issue.

Since the Company believes it will have adequate capacity for initial possible commercialization with the two Grade B labs...

They are already planning to move forward with commercialization using the Grade B labs. It's plain as day that Flaskworks won't be verified or approved by the time we get approval.