Replies to post #592444 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Well Doc, since I don’t believe that Eden is a prerequisite for marketing approval, or currently a part of the marketing application,

In response to my inquiry about the application possibly being 'delayed' because the company anticipated (RA's signaled) that the approval would require manufacturing improvements in the form of the Eden system, the company told me that Eden is 100% not part of the current MAA, and they do not anticipate that it is needed for MHRA approval. In no uncertain terms, matter of fact, and beyond reproach. Eden is not being included in the application package.

This communication was about a month ago.

[exwannabe]

I agree that comparability will be between the process as used in Sawston and the process as used in the trial. No comment on how close it is.

Wonder if London has been using the exact same process as in the trial, and that is the reason it is still open. Not for capacity, but for a reference process.

[Doc logic]

hyperopia,

Very reasonable thinking and in line with what the company has said about their path forward but also like slogging through quick sand with regulators if comparability is taking this long for anything less than Edens at this point for submission of MAA. I sure hope Edens is catching up fast if all the rest is taking this long to validate because I believe there is still the product release bottleneck with all the hours of oversight required for each batch of vaccines until full automation with digital oversight is achieved. Seems to me that this is only remedied by Edens in place even with all the other processes being enclosed. Comments from the company suggest this is an area of great concern as the number of product release specialists is limited. Best wishes.

[georgebailey]

Hyperopia- what is the difference between semi automated and fully automated use of Eden? I’m not asking for an in depth explanation but maybe the difference can be described in terms of efficiency- fully automated yields a 10x production capacity improvement and semi automated yields ?x capacity improvement?
- in the context of current Specials Program production, do you think Eden’s is running fully automated comparability tests or semi automated testing?
Thanks in advance.