manibiotech,
By 2014-2015 the need for consideration of more than GBM became apparent. When “all patients” including crossover from placebo were apparently were benefitting this is when Linda recruited Shashi Murthy at Northeastern University and Flaskworks began to work on developing a model for scalability. By 2018 Linda was pleading for help to develop the early work with Flaskworks further and faster. By the end of 2020 I believe the evidence from Specials was indicating the potential for further needed expansion. After this is when the 1b artisan clean room expansion was being readied. By 2023-2024 I believe the evidence from the Specials Program and proteomics pointed strongly to the potential for expanding into other indications with an early nod in that direction with IFR indication change to cancer from GBM. This led to more expansion of leukapheresis dedicated space and conversion of planned for Class B expansion space to Class C for Flaskworks use.
Bottom line is plans changed from possibly pursuing approval in the US to starting with the UK which is a smaller jurisdiction where artisan had a better chance to be approved for initial commercial manufacturing of L and NWBO was getting good support from Neil Woodford at that time with plans for Sawston. NWBO needed to start with artisan on a smaller scale for GBM because Flaskworks was not being developed fast enough to expand more quickly in the US or any larger jurisdiction and there was more certainty about knowing if the SAP would be “approved” in the UK vs the U.S. but even those plans changed with time from just GBM to also include rGBM. Delays meant paying Cognate for unused space which was not a good use of finances.
If anyone still thinks that Flaskworks is not key to both regulators and especially NWBO’s business model I direct your attention to what Linda communicated when acquiring Flaskworks. In reference to the need for expensive clean rooms and highly skilled technicians to manufacture L Linda is quoted as saying “These factors have made manufacturing of immune cell therapies (such as T cells) very costly, and greatly limited the number of such therapies that can be produced. There simply are not enough of these specialized clean room facilities, not enough highly skilled artisan specialized technicians, and each technician can only produce limited amounts of products.” Now we can all speculate about Linda’s reference point with regard to what point in time she is talking about but I believe it has to do with both the business model needing to be profitable and the limits on funding from the UK. This is especially true in light of the hope to move into broad scale production for all solid tumor cancer types down the road which the change in IFR indication to cancer from GBM now points to as the path the regulators want to move forward on. This type of expansion is impossible with artisan and also impossible with just Sawston. This will take partnerships or franchises with deep pockets.
The lack of expansion with NWBO staff points to either more time needed to get there which means funding sources need to be lined up for quite some time (dilution) or plans for others to be more involved with funding and day to day work as partners. I believe in the “If you build if they will come” model. Investor082 does not or at least pretends not to; ). Best wishes.
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