Replies to post #150934 on NorthWest Biotherapeutics Inc (NWBO)

[Whitewater55]

Improved manufacturing. Confounding in Germany. FDA approvals.

Each of these kids is doing their own thing...

Slow down everyone.

[flipper44]

Another simpler scenario would be the following. Just a hypothetical.

If Germany PFS and/or OS quickly showed statistical significance.

If NWBO stopped the controlled trial in Germany for efficacy, but allowed the U.S to continue enrolling 31 more patients with the the original manufacturing technique because they had their tumor lysate and dendritic cells.

What do you do?

A significant number of sites from Germany might very well demonstrate statistical efficacy comparatively early.

Well, there is new AA FDA guidance regarding significant number of sites, and another one on early demonstrations of efficacy.

[HappyLibrarian]

Given what has been happening with NWBO it is pretty clear that the FDA decided to let DCVax L languish instead of stepping in and breaking their own rules out of the goodness of their heart.

Maybe something dramatic will happen in a couple of months but the real evidence we actually have suggests that the FDA does not appear to regard DCVax-L as anything special.