NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Good points on both fronts Gary. The German enrollment situation is genuinely under appreciated. Ethics committees there don't intervene lightly, and if they blocked placebo enrollment while allowing the treatment arm to continue, that's a meaningful signal about how the data was reading at the time.

There is zero reason to believe that happened, and plenty of reason to believe otherwise.

First, it was the FDA that issued the hold, and in response NWBO voluntarily halted screening in all countries. The "German Origin" theory was floated back when the hold was first discovered on the German trial website. It was much later when NWBO admitted it was an FDA hold, but certain posters kept with the old story.

Second, the German sites had very little OS data to work with. They had a single site, Dresden, open for a bit over a year and 4 additional sites just opened (probably too late to get patients into the IE data lock). So one site of 73 with a year of data? Likely only a couple OS events. Not enough to draw any sort of conclusion.

Third, NWBO denied any other changes besides the hold. The JAMA paper does not mention. The 2020 protocol and SAP assert all patients in the trial were randomized.

Against this you have zero evidence of this German Origin theory.