Replies to post #535088 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Irrelevant statements even after a highly successful P3 trial and publication of results that have been reviewed by a top journal.

Conclusions
This phase 3, nonrandomized, externally controlled trial found
that the addition of DCVax-L to SOC was associated with a clinically
meaningful and statistically significant extension of overall
survival in both nGBM and rGBM. Treatment with DCVax-L
also had an excellent safety profile and noteworthy tails of long-term
survival curves.

[hoffmann6383]

NWBO new the IA happened and knew of the results. Many would think that would factor into the decision to not use it.

More bullshit that was dismissed by a Federal Court Judge in a civil suit. This narrative has zero merit,

[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.

[Lykiri]

Documenting the Endpoint Changes:
Update the protocol in a formal protocol amendment. Not done until 9/23/20

Ex,
Wrong!

[lutherBlissett]

ex you are very talented at scrapbooking! have you considered reducing your carbon footprint and just doing some of these posts with scissors and glue? perhaps you could write a letter to the JAMA editors composed of letters cut out of magazines about all the worrying aspects of this trial.

i hope you're coping with the fact that actual experts in the field share none of your concerns. be well!

[RPD60]

Ex,
Ok I’ll bite on the fact that the trial endpoints were changed late in the game.

Now let’s go to the paper you cite about changing trial endpoints. In that paper they rightly reference the fact that changes to endpoints can lead to bias in the data

Please explain how changing the endpoints biased the OS data? How did the Statistical Plan permit patients to live longer?