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manibiotech

05/03/25 4:19 PM

#765727 RE: DJPele #765725

Well done I know some just keep speculating and posting it as fact or most likely outcome . And also that other indications were added to current MAA etc in the middle of review process. It's just crazy . 
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TheFollower

05/03/25 8:16 PM

#765762 RE: DJPele #765725

According to the June 2024 press release from Northwest Biotherapeutics, once the GMP-grade units are delivered to Advent BioServices, they will go through final qualification and validation. Advent BioServices will conduct engineering runs with the system to collect data for regulatory approval before the system is used for DCVax-L production. This means the units will be thoroughly tested and approved before installation into the Grade C labs.
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Steady_T

05/04/25 12:34 AM

#765777 RE: DJPele #765725

Would somebody please notice that the 10K is the status of events as of December 31 2024.
This is now 4 months later.
NWBO has been doing things since Dec 31.

It has PR'd that it has evaluated two versions of the EDEN system and selected one for production. That means that it has at least one EDEN unit that it can work with that represents production equipment. That unit can be used in the existing class B clean room if the company hasn't built out a class C clean room in the last 4 months.

The company has said that a class C clean room can piggy back on some of the existing infrastructure of the existing class B clean rooms to get a class C space up and running for less cost and shorter time.