NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

olekbolek,

I think you are missing the main points being made. Dr. Linda Liau is saying that crossover to treatment instead of insisting this not be the case might cause the real benefit to be misread if crossover patients benefit from treatment and her experience with patients leads her to believe these patients want the vaccine no matter what because the side effects are minimal. This is in line with her statement that all patients seem to be doing better and that they are comparing early treaentry to late treatment. She mentions this as a potential confounding factor which needs consideration when judging a trial like this one, not because she thinks it is absolutely true.

Linda Powers brings up another concern which I believe is actually points to something that happened in this trial. Her argument is that it is unethical to put patients on SOC/placebo instead of use historical norms. If Germany insisted on not enrolling additional patients in SOC/placebo out of ethical concern for at least a subgroup her point hits home like a sledge hammer on a crystal glass. She knows how many patients were enrolled in Germany but she isn't telling us because this argument has not been validated by unblinded data yet or accepted formally by FDA. See how these 2 ladies are working their points in to the regulators to say "see, we told you so"? So if NWBO demonstrates strong correlations to benefit from biomarker analysis and other sources whether from early treatment or late treatment, their arguments hold up and should not be able to be circumvented by subjective regulator decisions against them. They are presenting logical reasons now why future trials should not require a placebo arm so that when they have demonstrated a statistically valid correlation from data from this trial it will be accepted for future trials. This is exactly how the process of acceptance of change in guidelines works over time. Best wishes.