NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

One of the surprises in the IMUC data was that they feel pretty certain that their placebo DC's, which are not exposed to any antigens, are elevating the control group OS. Does anybody know if we are using similar DC's for our placebo here?

If so; if NWBO is using live DC's simply not exposed to the tumor lysate, and if an increase in control group OS over historical norms is observed, then the FDA and EMA should take that into consideration.

For such a response to be observed in just one trial would have X weight. But for such a response to be observed in two competing trials should have 4X weight. Ie, it becomes 4 times as credible that the effect is real, and crosses the threshold into irresponsible to ignore.

Let's just hope it is not too good an effect, or this whole antigen thing is a waste of $ and time. It would bode well for Direct, however.

But why the hell do they use live DC's as the placebo? Are they afraid patients are going to go home after injection and put their band-aids under a microscope to see if they see DC's, live DC's? No... It must be to prevent clinicians from doing similar to find out if a given treatment/patient is control or experimental group. What a shame that they would have to go to such lengths, but kind of impressive that they go to such lengths to prevent tampering with the trial.