NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

That makes sense to me Pyrrhonian. To allow statistical significance for these smaller subgroups based on CD4 count, you would have to have a lot more events. And this would be the right way to handle this situation.

And I think you are right that the placebo patients would not be grouped altogether here. A 1 for 1 comparison in corresponding subgroups makes sense. One minor alteration to Anti's model in post 17074.

As LP said, it is generous of the FDA to allow this change. NW was responsible for having large enough trials before Phase 3 to ensure, statistically, proper representation of such subgroups. And apparently they did not.

What makes it reasonable in my opinion for the FDA to allow this exception is that this damaged/dead immune system issue is total FUBAR for immunotherapies that should have been better anticipated by the rest of the medical community including regulatory. It was quick sand for all the immunotherapies that include radiation as part of SOC. I do not understand why this issue has not been extended to chemo. I read an article that showed that many patients do lose their immune systems, at some point, from Temador and that this is often the reason they die. But if the tell on that damage is also a drop in CD4 counts, then this method of sorting out the issue will work for the effects of chemo as well. Down the road, or sooner, they need to learn how much is too much for both radiation and chemo when used with immunotherapies, and these CD4 counts might prove to be the proper feedback.

One concern I have about these hypothetical plans for subgroup comparison by CD4 count is whether they have that data for all the patients. Maybe for living patients, they can just add that test at this point going forward, but what of patients that have passed away? Do they keep blood samples for post analysis? Did the white counts that were likely done along the way include CD4 measures?
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My apologies to the MD's on this message board for lashing out at the medical community. You represent some of the most valuable posters on this message board. But I hope you understand my frustration. I think the downside of free enterprise and competition in medicine shows here. I am not saying it should be more socialized. I am just saying that the FDA needs to take on more responsibility in examining this type of issue if the industry is not going to do it. These individual immunotherapy sponsors should not have been on their own here.