NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

Meiluc, I expect/hope the artisan method will be used at least 2 to 6 months ahead of when the first few Edens are expected to be up and running. I also expect that we will not be through the inspections until at least the end of this month and probably through part or all of September. I say this based on the way the 10Q read: they wrote that the inspections were scheduled. It was not written to indicate they were in the midst of doing inspections. However, I felt like the inspections were imminent because of how the language had changed from the last 10Q and that management now has a handle on not only when and where they'll take place, but also how many inspections will be done. Consequently, there was far less emphasis in this 10Q on mock inspections and no talk of getting everybody, everyplace, everywhere ready.

August 2024:

Preparations for Regulatory Inspections. As previously reported, preparations for regulatory inspections associated with the MAA have been a major focus of the Company’s activities this year to date, including mock inspections. Inspections by MHRA are scheduled to take place in both the U.S. and the U.K.

March 2024:

Preparations for Regulatory Inspections. As anticipated in the Company’s prior reports, preparations for regulatory inspections associated with the MAA have continued to be a major focus of the Company’s activities this year to date. The Company has continued working intensively with teams of expert consultants in both the U.S. and U.K. on these preparations, and has also arranged for further mock inspections by specialists who were formerly inspectors for regulatory agencies. It is anticipated that teams of multiple inspectors for extended periods will conduct comprehensive inspections of all the key parties involved conducting in the Phase 3 trial and of all documentation and records. The Company does not know when MAA - related inspections may take place.

But to get back to your question: Do we need that first unit validated? I went back to the February PR and examined the details and realized that NWBO has already produced similar results from its multiple prototypes, which means that we already know it works! (I guess I knew this before but lost that detail in these recent delays). This is what they wrote in the February 2024 about what they had already accomplished:

Development Work That Has Been Completed

This work has now been completed and has included:

Determining the fundamental type of mechanized approach to most closely mirror the existing manual process of manufacturing DCVax-L;
Designing and creating a new machine to implement this approach;
Making numerous prototype units and progressively optimizing the system;
“Closing” the manufacturing process so that it does not involve any “open” steps (i.e., open to the air in the manufacturing lab) and therefore does not need to be conducted in the most sterile and most burdensome and expensive type of manufacturing lab;
Automating key steps in the manufacturing process involving isolation of the desired immune cells, feeding and culturing those cells, and extracting them from the culture vessel (which involved special difficulty, as described below);
Producing finished DCVax-L products with substantially the same composition and percentage purity of dendritic cells, the same biologic profile and functional characteristics of the cells, and the same yield in number of doses as with the existing manual process.

Yes, the last part in red tells us that they've already validated, at least to themselves, that the prototypes produced the same percentage of dc purity, etc., etc. as the manual method. I would bet MHRA knows that! I also suspect that they thought resolving the cleaning and safety issues - the two issues noted in that March 10Q - would not take so long. Three months ago the May 10Q said this:

The Company believes the work is on track for the GMP adaptation work to be finished in the near future, and the first GMP units to be delivered to the Company soon after that.

. But it's only been 3 months so perhaps it's still on track.

Yesterday's 10Q says:

The design work to make the Flaskworks system GMP-compatible was completed

What it doesn't say is whether they began making... or will soon begin making... an Eden unit from that design. I don't know if they chose to not give us any timeline because they keep missing their own timelines or if they do actually plan to introduce the smaller footprint with this first rollout of Eden. An earlier PR/comment gave me the impression it took about 2 months ti "make" the first Eden.

So, based on all these things talked about by the company, I don't believe that Flaskworks/Eden development will slow down MAA approval. I believe MAA approval probably won't happen until September at the earliest, maybe October to get inspections done and a decision debated, and that Eden could by validated sometime between November- January. But that's just my very humble opinion based on what the company has talked about.

P.S.: I don't think NICE will be delaying these decisions, but is staying up-to-date with what is going on with the company and it's application for marketing DCVax-L.