NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Maverick0408,

Your opinion is basically what we were told by management 3 years ago and what I expected too. Artisan rollout followed by Edens improvement. The problem is that meeting demand I believe became a bigger issue than originally anticipated hence the need to build a bigger boat. Preparing for demand is not just about having space and clean rooms, under the artisan method it would require sufficient qualified artisan trained personnel and meeting demand must be proven to be possible sooner in Europe than in the US. The MIA certification would not require the same proof of capacity that MAA would require which is also why there is a separate inspection of the facility during the MAA process. Some claim that because Advent has space and clean rooms that’s enough. It’s not! NWBO specifically pointed out supply chain and product release issues that they said they were working on and they have never stated that those were completely remedied. No one submits a BLA until those issues are remedied and NWBO has never said how they were going to remedy this but... they did say they were working on optimization of manufacturing. Could that help with supply chain issues or product release issues and would that be something that might come in later than all the rest of the application when those issues are finally resolved ie as part of a “key section”?; ).
Manufacturing preparedness is the way the Europeans roll and it does make sense for governments not to invest time into something that a company or investors only think might work. European product release standards for cell therapies are more restrictive than in the US too and no one is certain exactly how much time is involved with product release because the artisan method depends on a per batch oversight process. I have no problem with the scenario that NWBO said they would pursue and that you insist will be the route taken with artisan first other than the length of time taken to get this done. The time taken to submit until now does not make sense unless waiting on Edens because of limitations possibly unable to be addressed by the artisan method trying to accommodate expected demand and pressure to keep the price as low as possible. Best wishes.