NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

That raises an obvious question: when does “intent” change?
If NWBO uses the manual process for one week? Two? Five? Six?

I think this is probably the best leg NWBO has to stand on, which is that they can say: Until we have another approved manufacturing method, we intend to use artisan. There are any number of road blocks Flaskworks could hit over the next 6 months that would make it irresponsible for NWBO to pull the intent to use artisan. They are hoping for 6 months from now, but what if construction efforts get massively delayed? There are lots of long lead materials that could have hangups. It's entirely plausible that Flaskworks isn't ready for certification until 2027. I think with that much uncertainty, the MHRA would agree with NWBO that the MAA is based on artisan and it is in good faith the intended route to commercial manufacturing at this moment in time.

That being said, I do agree 'intent' is being said with a bit of a wink and a nod. You're not wrong that the real answer to the question of "how is DCVax-L going to be manufactured at commercial scale" is "with Flaskworks". So as you alluded to, how aware is the MHRA of that information and what are they willing to turn a blind eye to/blur the edges for?

I think NWBO has the more 'technically correct' side of the argument here, and common sense is also on their side with "this needs to be approved now for artisan and we'll figure the changes out later". So I think the coin will drop our way on this issue. But I do think the MHRA could absolutely pull the rug out from under artisan if they wanted to based on that language you received in response to your question.