NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

While we wait for news, I just went back over management's Feb. 6th PR about Flaskworks in an effort to remind myself of the facts (and correct my memory in spots!). Here's what I found noteworthy:

The next step is to have GMP-compliant (i.e., clinical grade) versions of the prototype Flaskworks machine made with GMP grade materials. A specialized contractor has been engaged to do so. This process is expected to take several months, in part due to ongoing supply chain issues.

Fact:
1) The contractor was already engaged (hired) as of Feb. 6th.
2) The reference to several months only refers to the making of GMP-compliant machines, not to the process of testing and getting the EDEN machine approved for use by MHRA, which we don't have a time-line for.
3) Supply chain issues are still a problem, and this problem is why manufacturing the unit will take "several months".

The implication I get out of that last statement is that manufacturing the first units would take less time without supply chain issues, and for future expansion, and when supply chain issues are resolved, this is good to note.

Then the PR says this:

As soon as the GMP-grade units are delivered, Advent BioServices will undertake final qualification and validation of the GMP units and use engineering runs with the system to collect data in order to submit an application to regulators to approve the use of the system for production of DCVax-L for patients.

Fact:

4) The manufacturer is making more than one unit even though the unit has not been approved yet! I didn't catch that the first few times I read this PR. So right from the get-go we'll have more than one EDEN unit up and running when/if MHRA approves the unit.

Then the PR continues;

The Company is optimistic about this approach because the Flaskworks system now closely mirrors the existing manufacturing process, and the DCVax-L products manufactured through the Flaskworks system are substantially comparable to the DCVax-L products made through the existing manual process.

Fact:
5) the company sees no reason for the MHRA not to approve EDEN because it's "substantially comparable" to the existing manual process. Substantial means: ample, consequential, large


The PR's benefits section also points out several important benefits of the EDEN units:

6) up to 12 patient treatments can be created in one lab that currently, manually, can handle only one patient treatment.
7) Fewer people are needed, particularly fewer highly trained experts who are difficult to find and employ
8) Less expensive clean rooms are needed.

Finally, it notes that a new patent has been applied for. That means potentially longer period of protection for the EDEN unit.

Though I have to ask, how can you copy a manufacturing device that's only being used in-house by it's owner? I don't expect NWBO to ever place EDEN under the control of outside companies.

All good stuff.