Replies to post #197510 on NorthWest Biotherapeutics Inc (NWBO)

[iwasadiver]

I think it’s a matter of looking at MRI’s of events of the treatment patients. I believe someone caught on that some treatment patients were showing a different type of pseudo progression than that of pseudo progression fromSOC (chemo/radiation effect). If a criterion for identifying true progression in SOC took a lot of hand wringing and expert panels to develop think of what one would do when you now had to wonder after the fact if a progression on DCVax was actually a progression and not pseudo?

The entire premise of PFS is that it’s an indicator of efficacy and survival in a disease that kills quickly; so if PFS is delayed compared to SOC/placebo an inference can be made and the treatment approved more quickly. Now, if you find that treatment PFS is poor but the patients keep living beyond expectation you’re suddenly in uncharted territory; wtf is going on? If the whole cohort is living longer, including this who’ve progressed on placebo and crossed over AND those who’ve progressed on treatment then you’ve really got a head scratcher. You begin to ask if there’s something about the treatment that’s enhanced on recurrence, or you ask whether the treatment progressions were true progressions. Either way, in my opinion, it wouldn’t matter if PFS was significantly better or not, regulators would only be interested in long term survival because of all the complicated possibilities.

So you take it all the way; you find there’s a new paradigm for all of this, and you reset the entire definition of efficacy in immune therapy. You wait to start the Direct Trials. You wait to start the combos. You wait because you’ve uncovered the new basis for studying these treatments and these diseases. You don’t rush to satisfy the noise. You wait.

Personally, I believe PFS will indeed be significant. But I also believe they’re waiting for the trifecta

[Rkmatters]

The 248 PFS event — Phase Iii primary endpoint — occurred sometime late 2016. They just didn’t do the statistical analysis.

The 233 OS secondary endpoint passed sometime last summer. They planned to do the analysis on that until after the study ends.

They are opting to let additional progression free survival events and overall survival events accumulate, from the 331 patients enrollment, as the trial heads towards data lock completion. It is my long-standing view they plan to conduct the primary, secondary and tertiary endpoints once all 331 patients complete their study consents.