NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Have we heard anything about Edens of consequence in the last year?

The last we heard is that were testing several versions which used different process to see which to develop and when they had one in hand they would have to prove it made the same product..

I'm happy to say we feel that we've made considerable progress. Again, just to give you a flavor of it, we've tested multiple versions of the system. We've tested versions that had high rate, high flow perfusion of the culture and media. We've tested low flow or slow rate of perfusion. We've tested static cultures, all of which is to reach specifications about the yield of these products made through the automated system.
And because when we're ready, to ask for approval of this manufacturing system from regulators who are going to have to approve to their satisfaction that the product that comes out is fundamentally equivalent to the product that comes out from our manual manufacturing process today. So we've tested a number of versions of the system. We have a test system established at the Sawston facility. So there are teams working in tandem at Sawston and at Flaskworks facilities in Boston, and that is progressing.

During 2023, the Company anticipates that additional key areas of focus will include:
...
continued development of the Flaskworks system, including choice of the system version to take forward;

So they have a stated goal to chose a version to develop this year. And we have heard crickets on that. When they do, they have to prove tp the RAs it makes the same product. As they have clearly stated they are looking at significantly different processes, this is not just automating the existig process as bio asserts. It will take an equivalency trial.

BTW, there are many other players in this space. just one