Replies to post #797901 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

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.

[sukus]

Slave1,

This is not very obvious especially for me. I thought originally the automatic device Eden was designed for DCvax-L to mimic how the artisan method was done.

I read somewhere Mimicking the artisan method is key so the device should produce almost the same result or biosimilar.

It is very lengthy and time consuming process I believe because mimicking something out of certain artisan methods is very hard. Therefore they had spent many years trying to get the best outcome.

But after reading your post, I learned something new today. You could be right. I also like to believe if the version of Eden device today is much more advanced and powerful than the version two years ago. I’d like to see the efforts are successful so that manufacture hyperactive DCs can be accomplished via this device. That would be good preparation before starting the next DCvax-Direct trials. Years of struggling to develop something good and useful finally yielding great results.

Yes, I would love to see this new Direct trial to use the greatest and latest version of Eden. If that happens, lessons learned from DCvax-L trials implemented to Direct trials. So when regulators let’s say ready to approve Direct because the tumors were melted by the hyperactive DC, the manufacturing is ready without any further delay. All IMO.

[Doc logic]

Slave1,

I believe the issue is resolved by the wording that exwannabe pointed out in the filings and I believe the reason this is the case is the two products are dealing with different levels of terminal polarization strength with more mature DCs being highly polar so the components likely need to be somewhat different. I also agree with exwannabe that the issue likely is already resolved as the wording in the Q points to just the IND paperwork being reworked to take advantage of new opportunities. Best wishes.