Replies to post #549598 on NorthWest Biotherapeutics Inc (NWBO)

[antihama]

Yeah, they must be evaluating Flaskworks and not the semi-manual process for the commercialization license. I was SMH and thinking they were ultra conservative when I first read the July PR indicating “the Company is hopeful that a manufacturing license for commercial production of cellular products in the Sawston facility may be approved by year-end” when they already received HTA and Special licenses (w accompanying inspections) for the Sawston facility in 2021. I wasn’t thinking they’d skip the semi-manual implementation and start w Flaskworks from the get go but it looks like they are. It’s gonna be something (like Wow!, Double Wow!!, and Triple Wow!!!; OK the Triple Wow was a pump) when we hear they received the commercial license and it includes Flaskworks! As an aside, I’m not seeing it as a Flaskworks computer validation issue but of course, it could be. My take is that any computer validation is a module or 2 within the Autolomous (ISO 9001:2015 & ISO 27001:2013 certified) system and they inspected Automolous in the previous inspections so just rinse and repeat in my mind. But as DI responded to Flipper last year

Parallel to that track is getting Flaskworks technology to be producing vaccine to enable in essence bio comparability studies.

That to me sounds like they needed to define/compare better the in-process/ID tests between the 2 processes. Say they had an inspection 3 months ago and the Agency asked them to define some process/ID tests better, that’s a good several months of validation work. Who knows. Anyhows, the point I was getting at w this post was that even w implementing Flaskworks the July’s PR hope of a Dec MIA approval, as you note, shouldn’t have any major show stoppers and we’ll see approval soon.