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Re: Slave1 post# 797901

Saturday, 11/15/2025 2:06:51 PM

Saturday, November 15, 2025 2:06:51 PM

Post# of 822168

Doc logic, one thing that stands out here is that even without pulling up any filing, it would not make sense to validate an automated closed system like EDEN and then confine its use only to DCVax-L while keeping DCVax-Direct on a legacy workflow. The biology and the engineering make that almost impossible.


The Q3 (and the last several SEC Q/Ks) states clearly Direct will use either the legacy TTF system or a commercially available system.

But why believe what NWBO states when you can just make up stuff?

(d) Technology Transfer: Clean Room Implementation.

After the choice of system (TFF vs commercial) and the choice of product composition are decided, development of new SOPs and transfer of production into the clean rooms. This includes pre-clean room engineering runs, establishment of critical quality attributes, and process performance qualifications.

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