Replies to post #479433 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Chiugray,

I have to disagree, I believe that NWBO knows that DCVax-L only needs to be judged on the two goals they established and it will do just fine. I don't know that they'll convince the U.K. and Europe to remove the others, but I think the FDA has passed on what's in Clinical Trials, and I believe that's all they'll require.

Any goal involving PFS clearly can't be met because they can't differentiate between progression and pseudoprogression. While pseudoprogression should be considered a positive, it's not one that's proven between trial patients without going beyond scans. It's data they don't have for every patient. In short, it can't be proven so why bring it up.

I'm hoping the Journal clarifies all of this and frankly I cannot say if it will address the goals from Europe, or not. I believe that Clinical Trials here had to be updated to get the Journal published, but now that it has been, hopefully it won't be long before it's out. I believe that the Journal knew what would be in the U.S. Clinical Trials database, but it had to be in print before they could move.

Gary

[HappyLibrarian]

OS is gold standard

Placebo double blind for OS is the gold standard and because everyone including the placebo patients lived longer we are hoping the FDA or at least the UK regulator will create a new gold standard namely a blinded trial for OS with historical controls.

I believe in historical controls because they represent the real world results a new treatment is trying to beat and while placebo sounds good in theory for something like GBM they will never be ruthless enough to use it in a scientifically valid way.

But right now we are asking the FDA to formalize and retroactively employ a new gold standard to our treatment when we are an under resourced and politically unconnected company and it could adversely impact their BP partners.

This is a big ask and is still more likely than not to happen (especially if the UK follows through and that builds public pressure and awareness) but it is not guaranteed or quick and this explains our current SP.