Replies to post #546100 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Thanks, thermo. Those are fair arguments. LL put in a slide in her talk last year at the University of Utah that gives an idea of what it would be like denying an effective therapy.

[jon_k84]

100% the way I see it as well.

If DCVax was highly toxic, I could see regulators wanting to see more data on it before approval... but it's not, the only thing it will cost patients is their insurance $$$.

We also have a very long survival tail that isn't fully explained by the "time-bias" concern. You have people living 10-15 years. Can any other treatment (including Dr. Stupp's Optune) boast that? Will regulators risk denying that very real possibility to someone? I don't think so.

The unpublished combo trial of 55% 2 year survival further supports this thesis.

There is academic merit to Dr Stupp's argument, to be sure, but the evidence is in DC Vax's favor.

[hope4patients]

Dr Stupp embarrassed himself with that article. Patients and families of patients see it. “Historical” controls were not used. Contemporaneous controls selected by a 3rd party were used, as you know. The rGBM benefit is something he decided to avoid. Embarrassing that he allowed this to be published is an understatement.

[CrashOverride]

He said the trial was a failure by arguing we had selection bias in our screening protocol. He's pretty worthless now as the Liau Protocol has shown everyone in JAMA. Good luck collaborating on the new oncology platform, Roger.

[flipper44]

Temodar at its current dosing protocol interferes with t-cell efficacy. Thus it interferes with t-cells charged by DCVax-l. Temodar has no function in fully unmethylated patient tumor profiles. Thus explaining why DCVax-l functions well in methylated MGMT and rGBM (the latter does not receive concurrent Temodar). It’s possible Temodar could stop hindering DCVax-l charged t-cells if Temodar’s dose is reduced enough to stop t-cell interference but still interfere with DNA repair of tumor cells. So you may have thought long and hard about this, but you should think further.

[Bright Boy]

Nice comment, Thermo! And I read a tweet from Dr. Zivic, our incredibly talented and hrd working ER doc when he said Stupp is walking a thin line. Well, all the comments are certainly valid and have been read many times before and I agre there is a "fine line between becoming a hero and a memory" and Stupp is desperately trying to cling to the "Hero" part when he had the Stupp protocol as SOC. That my friends was a long time ago and his thoughts are very outdated, but more importantly, his heart is in the wrong place. Clearly, he has given way to financial and political considerations and lost touch with the patients that he swore an oath to protect!!! No excuses for a guy like that!! Period-End of Story!!!

Cheers,

BB

[dennisdave]

An externally controlled trial was never going to be as compelling as a placebo-controlled trial. Stupp points this out with his “it remains to be demonstrated” line. But non-placebo-controlled trials get approved when the need it great.

The problem remains that a controlled trial needs patients to remain in the control group to die so they can be better compared to the treatment arm and in doing so take one for the team.
Patients will never accept that and will demand treatment, especially now after the JAMA article. Stupp should know that. Stupp should also know the FDA demanded NWBO send patients to treatment. Thus leaving no other option than to compare treatment with RWE data.
With lethal diseases like this, control arms without a crossover are no option.