Replies to post #570436 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I’ll be the first to congratulate you and others if you guys are correct. If not, I will not berate you.

[CaptainObvious]

I'd be willing to wait for that.

[hoffmann6383]

I'm not certain there is a delay with the MIA. We aren't far past NWBO's estimated timeline and we know that the MHRA was way overbudget and having to make significant cuts, including cuts to their headcount. This could very well be the reason this is taking longer than NWBO's stated end of year hopeful deadline (an understaffed MHRA).

Cut and paste excerpts from the below report.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1093177/MHRA_Annual_Report_and_Accounts_2021-22.pdf

We are seeing a slower timeline for the MIA than $NWBO's EoY goal. We are also seeing backdated and erratic updates at the MHRA's MIA webpage.

Why?

Lots of possible reasons, one of which may be a headcount reduction and tech budget reduction at the MHRA.https://t.co/dreujDuIDf pic.twitter.com/bqvvQLLLBm

— Hoffmann (@hoffmann6383) February 23, 2023

[meirluc]

Smokey, I believe that Flipper recently posted that Sawston is now advertising the hiring of clean room technicians. Why would they be doing that if NWBO included the Flaskworks/Eden system in its MAA application, unless they intend to utilize for some time after approval, both the manual and automatic manufacturing systems.

[hoffmann6383]

And because when we're ready, to ask for approval of this manufacturing system from regulators who are going to have to approve to their satisfaction that the product that comes out is fundamentally equivalent to the product that comes out from our manual manufacturing process today. So we've tested a number of versions of the system. We have a test system established at the Sawston facility. So there are teams working in tandem at Sawston and at Flaskworks facilities in Boston, and that is progressing.

^^ The above statement from the ASM that NWBO hasn't yet applied for approval of flaskworks leads me to strongly believe flaskworks will not be incorporated into the MIA. Flaskworks will come at a later date, imo.