NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Here are a few of my observations when comparing the 2018 10K with the 2019 10K.

The differences mainly concern Advent, Cognate, and the SAP.

First - there's this new paragraph in the 2019 10K:

We negotiated a new agreement with Cognate for production of DCVax-Direct products in 2019, and we will need to negotiate a new agreement with Cognate in 2020 for production of DCVax-L products for commercial purposes and new programs. We also need to negotiate an agreement (Statement of Work, or SOW) with Advent relating to the design, development, buildout, testing, regulatory inspection and regulatory certification of a new manufacturing facility in Sawston, UK, and a new agreement with Advent for production of DCVax-L products in that new facility when it is ready. We also need to negotiate an agreement with Advent for production of DCVax-Direct in the UK. There can be no assurance that we will be able to negotiate favorable terms in each of these agreements. Following negotiations, if it is necessary or desirable to change our facility design and development arrangements or our manufacturing arrangements, that could involve increased facility costs and/or increased costs related to manufacturing of our products, and could result in delays in our programs or applications for various regulatory approvals.

Second - below are the sections from the "Overview".
From the 2018 10K, they've removed the passage in the 2019 that I've highlighted below. Why not keep it, unless the pathway, or roadmap, is now established?

As previously reported, the Company is now moving forward with the several stages of work that are needed to reach completion of this trial. These include finalizing the Statistical Analysis Plan, conducting the final data collection, data validation and data lock, and then unblinding and analyzing the data. Each of these stages are multi-month processes, involving teams of outside experts as well as Company personnel. This work also involves substantial pioneering, without a well-established pathway or roadmap. Accordingly, the Company’s projections, estimates and expectations are subject to material changes as the work proceeds.

From the 2019 10K - same "Overview" Section (pages 21 and 22):

As previously reported, the Company has been moving forward with the several stages of work that are needed to reach data lock and unblinding of the data from this Phase III trial. These stages include completing the draft Statistical Analysis Plan, conducting the final data collection and data validation, then data lock and unblinding and analyzing the data. Each of these stages involves teams of outside experts as well as Company personnel. (NOTE THAT THE PASSAGE HIGHLIGHTED ABOVE IS REMOVED.)

(NOTE: THE FOLLOWING PASSAGES ARE NEW)

The Company worked with three sets of highly experienced and independent statisticians, from both the U.K. and the U.S. to develop the Statistical Analysis Plan (SAP).  The Company is continuing to consult with its Scientific Advisory Board, independent consultants and the Board of Directors to move forward as prudently and expeditiously as possible to data lock, unblinding and top line data.
 
The independent contract research organization (CRO) managing the trial has been moving forward on the final data collection site visits and query resolutions to complete the trial data. The Company’s understanding is that the site visits are nearing completion and most of the queries will have been resolved, with only a modest number remaining outstanding. In parallel, the medical monitors are checking the blinded data as well, and other third parties are collecting confirmatory information.

If one wants to wordsmith these passages, the 10K cites that they "worked" instead of are still working to develop the SAP. One will note that the SAP is no longer included in the topics that they are consulting with the SAB et al. They are usually very careful with their changes in these reports, so it would seem that for the most part, the SAP is completed. If the SAP were still a topic of discussion with the regulatory agencies, wouldn't it still be a topic with the SAB and their BOD?

Third - under the "Operating costs", there are notable differences as well.
From the 2018 10K:

Operating costs:
 
Operating costs and expenses consist primarily of research and development expenses, including clinical trial expenses, which increase when we are actively participating in clinical trials and especially when we are in a large ongoing international phase III trial. The associated administrative expenses also increase as such operating activities grow.

In addition to clinical trial related costs, our operating costs may include ongoing work relating to our DCVax products, including R&D, product characterization, and related matters. Going forward, we are also incurring large amounts of costs to carry out and complete statistical analyses, process validation work, final data collection and validation, and other work associated with moving towards completing the statistical analysis plan for the trial and obtaining approval of the plan by regulators in all of the countries where the clinical trial has been conducted, data lock for the clinical trial data, and unblinding and analysis of the data.

From the 2019 10K - the passage I've highlighted above has changed. You'll note the the word "completing" the SAP in the 2018 passage is now instead revised to performing "statistical work for" the SAP.

Operating costs:
 
Operating costs and expenses consist primarily of research and development expenses, including clinical trial expenses, which increase when we are actively participating in clinical trials and especially when we are in a large ongoing international phase III trial or we are completing such a large international trial, and undertaking substantial one-time expenses such as for final site visits, query resolutions, statistical work for the Statistical Analysis Plan, preparations for data analyses and other activities related to completion and assessment of the trial. The operating costs also include administrative expenses associated with trials, and increase as such operating activities grow.

Unless someone else has a better interpretation to present, these changes point to the SAP work being completed.

And as to Jerry's recent note that the Board information under Section 10 had been basically eliminated and that they reference the 2020 Proxy Statement that's not yet been filed... that does seem odd, in that they could have easily just listed it, same as they do every year. Listing it as such draws attention to it. Perhaps there's a blah reason as to why they did this, and perhaps there's another reason that falls under "interesting"... we will obviously know when they file the Proxy as it's in that this will be filed.