NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Senti, it appears NWBO is being very guarded in its 10Q regarding the phrase process validation work, but there it is. Good find. Here (as I see Evaluate already pointed out) is a section from the January 27, 2014 PR regarding large scale expansion of manufacturing capacity.

For example, even for products that have met the rigor required to proceed in Phase III trials, the further product validation work required for such products to be considered for commercial approval at the end of such Phase III trials requires well over a year of extensive and intensive work. Similarly, the infrastructure and systems for managing such cell therapy products for thousands or tens of thousands of patients (or more) are extremely demanding. To date, other companies have not successfully scaled up to such levels on a practical basis. By entering into this major development program now, the Company is getting an important head start.

“We are excited to enter into a broad program to expand capacity and build large scale infrastructure, systems and operations under these Agreements with Cognate,” commented Les Goldman, Senior VP of Business Development at NW Bio. “Such a program is essential for our future success, and involves a major commitment of resources and time -- NWBIO January 2014

It would be difficult to know then, in May 2017, where the company exactly is when it states, "going forward, we will have to undertake process validation work," because they have already conducted validation work throughout the trial processes.

But perhaps there are a few clues.

Remember this job posting that was also added to calendar services back on April 3, 2017.

flipper44 Member Level Monday, 04/03/17 03:56:34 PM
Re: None
Post # of 117635
Manager, Validation Services at Cognate BioServices, Inc.
Memphis, TN 38118

Quote:
....Support manufacturing to satisfy the quality and process validation requirements for existing products in a rapid growth environment as well as participate in the development and validation of new products, as needed....

This is a new job position listed today for the first time.

job-openings.monster.com/v2/job/View?JobID=182548209&MESCOID=1100016001001&jobPosition=3

(The other 6 job listings are reposted but otherwise have been around for about one to one-and-a-half months.)

On the same date I posted this:

flipper44 Member Level Monday, 04/03/17 04:27:45 PM
Re: flipper44 post# 111335
Post # of 117635
Just for posterity, I wanted to paste the current job listings at Cognate:

Cognate BioServices Jobs & Careers
7 Cognate BioServices jobs found on Monster.

System Administrator II
Cognate BioServices, Inc.
Memphis, TN

System Administrator I
Cognate BioServices, Inc.
Memphis, TN

Manager, Validation Services
Cognate BioServices, Inc.
Memphis, TN
Posted today

WMS Specialist
Cognate BioServices, Inc.
Memphis, TN

Head of Commerical Manufacturing - Biotech
Cognate BioServices, Inc.
Memphis, TN

Quality Control - Microbiology Supervisor/Manager
Cognate BioServices, Inc.
Memphis, TN

Quality Control Scientist - Biotech
Cognate BioServices, Inc.
Memphis, TN

All these jobs were either filled or removed weeks ago, and from what you highlight in the latest 10Q gives me more confidence they were likely filled (as opposed to removed).

Process validation is an ongoing process, and while it can often be described in early stages of trial costs, because process validation must be done at each trial step as well, it seems NWBO succinctly wished to describe it "In addition to trial related costs....," so I get the feeling between adding a "Head of Commercial Manufactuing" and "Manager of Validation Services," NWBO is emphasizing the commercial side of things when it states, "going forward, we will also have to undertake process validation work."

The additional jobs above, apparently recently filled, also leave me to believe this is commercial readiness, not just phase II trial readiness.

Why so guarded? The 10K was a bit less guarded in terms of language related to "marketing" and "commercial" preparation, but 10Ks are also more inclusive. Long story short, I think the phrase you found goes to the heart of what is happening behind the curtain, and with enough background knowledge, one can try to read between the lines. However, critics are quick to remind us that this is exactly what NWBO is so good at -- getting investors to fill in the blanks with their imaginations.

I don't think the building expansion, and now clean room installations are imaginary. I don't think the critical employment positions above are imaginary. I do not believe the accumulation of 248 PFS events is imaginary and I don't think this trial can nor should go on indefinitely.

Finally, as I discussed with one or two other posters a while back, as seen by regulators in fairly recent guidelines, validation is something that is an ongoing (oversight) process even after commercialization has been achieved.