Replies to post #684812 on NorthWest Biotherapeutics Inc (NWBO)

[newman2021]

Yes, Engineering Run will satisfy the MHRA inspectors ... for example, actual cells from multiple patients are employed in multiple FW devices in the same Class C room typically during an inspection (in a mock setting), imo.

[flipper44]

Senti, are you of the opinion Eden will be approved “upon” DCVax-l approval or are you simply suggesting Eden will start engineering run testing upon DCVax-l approval?

[beartrap12]

Senti, thanks for zeroing in on "engineering runs" and explaining it, along with Newman. My question, which we may not be able to answer, is whether they use actual patient material to conduct those runs. If so, then perhaps Eden is being used as we speak. Of course, I'm slipping into conjecture with this last thought. Sometimes after much conjecture on this board, I like to go back and just review the facts.

[Doc logic]

sentiment_stocks,

Yes, that little piece of information is key to understanding that the “fitting out” of at least one operational clean room is likely being described. This model then can be replicated site wide and “franchise” wide based on an approved model. Since at least one clean room likely is or will be being fitted out with GMP grade units and the “site” has already been GMP certified, any final inspection, barring any unforeseen additions or subtractions, will likely be able to pass all GMP commercial scale final inspections. Within this scenario is the outside chance that multiple clean rooms are being approved at the same time as a site buildout.
I have long expected that at least one clean room would be Flaskworks fitted out to compare against artisan during the approval process and that still may be in play. If anyone has any question at all about why this has taken SO long since last patient enrollment, one word… manufacturing, manufacturing, manufacturing. Your mention of price concerns, which point to NICE input, have also certainly been part of the equation in subterfuge. Patient demand being matched with product availability is indeed cost related as most patients simply will not have the funds needed to pay for treatment themselves but the funds must come from a pool. Endless funding is not available except at the FED and IMF and even they are controlled by the puppeteers. Best wishes.