NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

--Median OS and Subgroups Etc----
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What is the median OS improvement for the CI's when they are showing efficacy for only 25% of the patient population? Isn't it zilch by definition?

I don't know what you mean when you say efficacy is 25%. Do you mean the 25% of the population is cured or that OS is 25% better so for example if OS is normally 15 months it is now 18-19 months? In either case MOS will be better. One just has to wait for 50% of the patients to pass away. In the second case that will happen sooner.

I mean 25% of patients receiving some CI's show great efficacy, sometimes an apparent cure. The rest tend to show no benefit... or that is my understanding. The % is lower for some indications for some CI's: We are talking approved CI's and indications.
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At the same time the statistical taboo in making up subgroups after the fact has a very real basis.

If you go back through some of the posts a few days ago apparently they did identify subgroups. The no-no for the FDA is when you let the data lead you after the fact. If they told them they believed the Mesenchymal subgroup would perform better and they do then that would be OK. Not sure if the phase-III is set up to determine statistical significance for the subgroups . . . that was being argued in various posts.

What do you mean "they" defined subgroups? Subgroups for the CI's or for DCVax-L? I am talking about the CI's here. For DCVax-L there were subgroups defined that might be similar to the subgroups that LL talked about in the long tail of the early open label data... but that is speculation. She spoke about mesenchymal. The pre-defined subgroups were based on observed response, not genetic composition.