NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Chiugray,

I believe that Specials data was submitted along with scientific evidence that DC therapy, in general by nature and specifically as presented by NWBO with their activation process, is indeed tissue agnostic. The emphasis being placed on platform technology in various comments by regulators points directly to DCVax and other things in development. I actually suggested in a post a while back that the additional 700,000 pages could include documentation related to this since the proteomics data had been developed and revealed. Biomarker confirmation was also presented I believe by Dr. Linda Liau at one point and the proteomics by Dr. Bosch in a presentation shared on this board.
What this all points to is a BIG proactive move by MHRA and NHS to advance the tissue agnostic validation process. Who’da thunk it?; ). THIS would create an absolute undeniable top priority to get manufacturing up to speed (the bigger boat) not only for NWBO but MHRA, NHS, NICE, FDA, PEI and all the rest. This would also explain why there has been no delay or backlog with regard to this application because it has essentially been a rolling application waiting on Flaskworks development. I believe development is also taking into consideration compliance issues for all the various regulators even though not applied to yet. NICE has been patiently waiting for something right?; ).
There simply is no other practical way than Flaskworks to advance the concept of tissue agnostic usage without creating major problems for NWBO and regulators for not having availability ready upon approval. The way to head this off for the time being is by creating limited access which is what the NHS individual application process will help do as prioritization and distribution will take place with GBM and rGBM likely being placed at the forefront. The idea of franchising also fits into the idea of rapid deployment once Flaskworks is validated.
So what this looks like to me is similar to a Phase 4 trial. Approval for GBM and rGBM 1st with individually applied for access for all cancer types while confirmatory review of data is ongoing during the buildout and validation of Flaskworks. Best wishes.