NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I think had Germany not been added and had they not just finished the approval of the Hospital Exemption, meaning the German regulator was very familiar with the treatment and was willing to let German a citizens get the treatment, then the results of the safety trial would not have caused a partial halt with the US alone, probably not either in the UK or Canada. Of course, I could be wrong, but as you note, I think the Germans are fastidious with ethics after their history with Nazi human experimentation. I think there would not have been the partial halt and I think the EMA website references it indirectly. One can think that is just because the EMA published it, and not the FDA, but then why is only the German regulator listed. At that time the UK was also in the EMA.

I think it was the Germans. Not a fault of theirs, just overlapping regulators with divergent views on ethics and placebos in these kinds of trials.

Again, just IMHO. I also think they likely could not explain the reason exactly to the company to preserve the company’s options on the trial.