NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

Antihima, I think we agree on inspections completed and Sawston certified. I can't help thinking that MHRA pushed for NWBO to search for C-labs in the UK and other work-arounds to the clean room shortage, to come closer to covering all patients. UK has about 3,200 new GBM patients a year and probably the same number of recurrent GBM patients. Management never mentioned reaching out to other companies to use their clean rooms until this current report. While it does sound like something Linda would come up with to fill the void, I would not be surprised if MHRA pressed her for a better solution while EDEN was waiting. And they came up with 3 ways to increase productivity:

10K:

The Company’s contract manufacturer, Advent BioServices, has prepared plans for how the manufacturing of DCVax-L products could be ramped up in the event of potential commercialization using just the existing two manufacturing suites and facilities, and could potentially reach a significant portion of the Glioblastoma patients in the UK. The plans include a transition from a single daily shift of operations to two shifts daily, supply chain considerations and determination of the personnel that would be required. The plans also include potential arrangements for a simplified initial Grade C lab, as described below. Advent estimates that this simplified initial Grade C lab could enable doubling of the production that would be feasible with the existing two manufacturing suites. Arrangements with private clinics have also been developed, as described below, which could potentially assist with initial commercialization.

These three items alone could have taken much of what feels like a lot of extra time.
Of course, ours was a huge application on a new and complex personal vaccine treatment for GBM, that may be applicable to all cancers, that has never been done before with a new manufacturing plant to boot.