NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

I can't quite follow many of these arguments. Almost... but not quite. That gives me the advantage of being able to step outside of the box a little, while gaining from the gist of what I read.

Doesn't a move to include the early progressives into the trial in both Germany and the US fit? All that is missing is for the EU trial description which still says that they do not include the early progressives. Maybe that is the only typo here.

This would fit with the stuff AV or whatever his name was on IV kept saying about the FDA wanting to include all patients.

And for the trials in Europe and the US to have such different protocols doesn't make sense. So perhaps the PEI has approved some aspect of the change and is reviewing the rest. Maybe they did a partial update of the protocol.

A massive extension of events would be required if a subgroup had only a small improvement and you wanted that to show within the noise by the end of the trial. Pyrrhonian just did a quick guestimation of a hypothetical split population in the group of 55 between true and pseduo early progressors. The guess part is because we don't know the population split, if any. Assuming there was one or more pseudos in that group, and the true progressors showed only 5 months improvement in PFS, then it would take a lot of events to make sure that 5 months showed up in the end as greater than 4 months with statistical significance. True even if that improvement was 7 months... not sure how high it could be and still need this large increase in events to stand out clearly enough over the goal of 4 months...

This assumes that a subgroup by subgroup pass is required, with statistical significance of some kind. And the added events also gives some cushion for the aforementioned need to show better performance than competitors for all subgroups. Less noise gives a higher minimum performance that can be attributed to a given observed mean or median. As you all know.

Maybe not exactly right here... but I think this might be the gist of the situation. Probably already said by you guys a dozen times... but that is my view from out of the box.

I used to have a boss that would repeat things that I said in meetings, maybe 2 minutes later, with the preface, "I just had an epiphany!". But this does follow many things I too have said in the past.