Replies to post #583792 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Thanks. Good riddance of Preusser as the EANO President.

[flipper44]

Here is their “concern.”

”we are not aware of any treatment, for any solid tumour, where treatment at relapse produces comparable survival to use in the upfront setting.”

What happens at recurrence, however, means TMZ is no longer effective at treating methylated mgmt patients. In other words. Chemo stops being effective, and thus with crossovers, tmz stops when DCVax-l is started.

All these scientists are aware that DCVax-l works primarily by expressing to t-cells, but tmz interferes with t-cells.

When DCVax-l is started, just as TMZ is halted, in the recurrent situation, the patients immune system — including t-cells — won’t be interfered with. However, the immune system has been left compromised by the prior tmz treatment.

What they pretend not to understand, is that crossover renders the comparison against placebo noncrossovers ridiculous, because they nearly all died early (but only include a third of control), and against the entire group because crossover makes the comparison against unimpeded by (pretreated) TMZ DCVax-l, a very high statistical hurdle.

That hurdle of comparison is also ridiculous, but because of very different reasons which make DCVax-l early versus DCVax-l late (possibly) too high of a hurdle.

That is also why one must turn to an external control arm.

That is why researchers, as their next task, are/have analyzed, for this phase iii data set, t-cell tumor infiltration and other immune responses initiated by DCVax-l and “WILL” correlate them with survival and “WILL” confirm prior studies making said correlations.

[Arby2000]

So. Dr. Short is a Novocure proponent. I assume then that she would not be speaking in favor of DCVax. To the extent that the president of EANO has any sway with KOLs and regulators, wouldn't that be another hurdle for approval in the UK?