Replies to post #654474 on NorthWest Biotherapeutics Inc (NWBO)

[Roman516]

Again, Mav-0408, your opinions are way off base, and it appears that you are once again clueless.

Your comment,
"Still you don't delay MHRA submission for months for NICE. They are 2 separate things."
Your opinion with no facts to support your comment.

Your comment,
"I will tell you one more thing - Flaskwork will not be approved in 2024!"
NOTE, the device is called Flaskworks not Flaskwork, makes you sound like you have no clue regarding the Flaskworks (EDEN) device whatsoever.

BTW,
This is a fact, the Flaskworks (EDEN) unit has been extensively tested for manufacturing consistency and accuracy for manufacturing at a high level of probability (>95%) over the past two years. The overall testing for the Flaskworks (EDEN) unit has been addressed in prior posts.

https://www.reddit.com/r/NWBO/comments/138158c/nwbo_flaskworks_is_a_game_changer_for_dendritic/

Your comment,
"And they will not have NICE reimbursements approved in 2024 either. However, they will apply to NICE in 2024 without Flaskwork."
The Flaskworks (EDEN) unit will be approved as it is an essential component necessary for high volume production based on its highly adaptive capabilities.

Perhaps look in the mirror and "Stop with your BS!"

[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.