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