NorthWest Biotherapeutics Inc (NWBO)

[GermanCol]

The endpoint of OS for 232 vs 99 is still a secondary endpoint of the trial and certainly has meaning. One would expect that if -L works then the 232 live (numerically) longer than the 99 despite the crossover.

It is exactly the opposite: The reality is that the less statistically significant the difference between the OS for the 232 arm and the 99 arm, the better the results for DCVax.

I will try to explain why as clear as possible, so we can end up with all this non-sense.

Following are the endpoints we are discussing:

1. The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in newly diagnosed glioblastoma.

2. The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in recurrent GBM.

3. The fourth secondary objective, OS, is overall survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.

** The first one listed above is the one used to prove that DCVax works for nGBM, the second one listed above is the one used to prove that DCVax works for recurrent GBM and the third one listed above is the one that doesn’t have statistical meaning anymore, but you keep bringing up to generate confusion and fear.


And following is the explanation step by step:

- First of all, a more statistically significant endpoint for recurrent GBM (first secondary endpoint or number 2 in the list above), means that the 64 patients that received DCVax after recurrence are living significantly longer than the SOC.
- If this happens, it means that the 64 patients arm is getting closer to the 232 arm because that arm is over the SOC.
- If this happens, it means that the 99 patients arm is getting closer to the 232 arm also, because those 64 patients are a subgroup of the 99 patients arm.

So, as a consequence of this, the fourth secondary endpoint that you keep bringing to the discussion (number 3 in the list above) results being less statistically significant.

Corollary 1: Going further, as a consequence of this, the probability of having statistically significant differences for the 3 endpoints on discussion (the primary, the first secondary and the fourth secondary) is very low. And because we know that the primary and the first secondary are statistically significant (which is greater news for DCVax for nGBM and rGBM), the most probable result for the fourth secondary endpoint you keep bringing up is that is not statistically significant.

Corollary 2: Going even further, it is better for DCVax if the endpoint that you keep bringing up is not significant.

Further, it would hugely positive. if even close to stat sig. Why would they not be shouting t out?

Precisely to avoid having posters like you changing the meaning of the results of that endpoint and other results to generate fear.

On the LTFU issue, you still have issues. Despite what you and flipper assert, finding censors does not have to lower the OS. It could go either way depending on how long the lived after the censor. If the censors were unbiased and random they would have no effect. True, there likely is some bias. But you still are talking a fairly minor effect from the few found LTFUs. More on the numbers on a post later.

Regarding this, I think Flipper has explained enough Linda Liau's comments about those patients and flipper and I what is the effect of censors.


*Sorry if something is confusing or has writing or composition mistakes, English is not my native language.