Replies to post #798937 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Thank you Beartrap for your input. One thing that bothers me is that
the response I received from AI implies that the switch from manual to
the Flaskworks methodology would obviously delay the approval and is
therefore a material event that should have been PRd.

euhhhh euhmmm huh?
As the Company has previously reported, the Flaskworks system is specially designed to carry out the key manufacturing processes for DCVax-L products on a closed basis. Flaskworks closed system as key to enabling DCVax-L production to begin taking place in Grade C suites rather than Grade B suites – and the Company views such transition to Grade C suites as central to large scale-up of production.

Other than that its not a material event

[meirluc]

If no approval until mid 2026, when will the DCVax-D trials start?
Will we have to wait another 7 months for anything substantial to happen?

[maverick_1]

From recall MHRA Application (2 yrs ago!) was NOT based on EDEN,

OR APPROVAL could be conditional on TIMELY EDEN installation

DIFFERENT STROKES for DIFFERENT FOLKS

[beartrap12]

Meirlic, the B-suites will be converted to accommodate EDENs. That was talked about at length a few years ago. Every B-room can accommodate about 10 EDENs. So, 10x 1000 patient vaccines, which I think is what manuel productiion is producing. You do the math!!!
I have been out of the mix for 3 days on the rode ( Paul McCartney concert tremendous for anybody let alone an 83-yearo-old!!!!) so I'm not familiar with what ATL said, But I am absolutely sure that B-suites will be converted to accommodate EDENs. 10 approximatly to a room; several rooms in every suite!!!!
Once we start producing EDENs, be assured, there in no stopping the production and expansion. If necessary, they will produce them 24-7.

This is what I've been waiting for!!!

[ATLnsider]

meirluc, I believe that you misunderstood my post. What I was saying is that DCVax-L manufacturing, after MHRA approval soon, will initially start in the Class B clean room, with the artisan method.

NWBio has said on several occasions that Flaskworks systems have to be used in Class C clean rooms, or Simplified Class C clean rooms.