NorthWest Biotherapeutics Inc (NWBO)

[thermo]

Ex, thank you for your thoughtful reply. From your recommended paper: “Wittes encourages consideration of changes in long-term trials, as medical knowledge evolves or when assumptions made in design of the trial appear questionable.” Medical knowledge regarding PFS measurement did evolve, and the FDA mandated cross-over arm made a randomized placebo O/S comparison impossible.

But, I’ll admit, this trial has been unconventional, and you have an argument. I thought carefully about the issues you raise but concluded differently. I don’t think knowing that PFS failed means you know an O/S comparison succeeded.

JAMA also considered these questions and put its reputation on the line.

I've raised your exact point with other academic neurosurgeons, and I’m not hearing significant concerns. What am I hearing? “Is it safe.”

Regulators are swayed by the science and data but also by reputational risk and patient stories. JAMA and the medical community are supporting this treatment.

I guess we’ll never agree to agree but you must admit, the trend is against you.