Replies to post #77346 on NorthWest Biotherapeutics Inc (NWBO)

[Lorie3168]

Please also note that DCVAXL Although clearly NOT effective on ALL GBM subtypes IS highly effective on the subtype that with SOC has the worst survival data.

[exwannabe]

Also for those who view this. Please comment on the possibility of the halt a year ago having to do with genetic subtypes. Seems genetics can rule out those that DCVAXL will absolutely not help.

I think all agree that DCVax-L is highly likely more effective in certain genetic subtypes than others. But how does this lead to the partial hold?

The point of the trial is to show that it works in the ITT population. The FDA is not about to say "Well, we suspect it does not work in some patients, so we are placing a partial hold". That just does not fly.

One might argue that NWBO sees the issue and is trying to change the trial protocol again to focus on the mess. subgroup or such. And the FDA is having an issue with the change. If that is your argument, possibly.

But if you think the FDA helicoptered into the trial with the parial hold based on the this, no way.