NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

More wonders from Zivoc (iwasadiver)

First, the EDEN process is not the same. NWBO clearly stated that the EDEN process was attempting to be close to the manual process.

Then he states they do not need a trial, only to show they make about the same DCs. Two main problems.

First, whatever metric you use for "about the same", the cells can not be manufactured w/o a clinical trial., Do you think the MHRA would accept rat data? If not, you need human patients. That makes it a clinical trial.

Second, and more important, it is not easy to say the DCs are about the same. If we knew exactly what makes some of these DCs work while others fail then sure. But we don't. There are general ability to characterize is all. That is useful to establish batch validity, but the RAs still have a highly characterized process that is the basis of any biologic.

I would assume a study to at least show a similar immune response would be needed. And maybe even clinical metrics.

Sometime next year expect to here news on that front.