Replies to post #159277 on NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

I agree with your premise whole heartedly. It has been argued that the 331 may not be representative of soc population as whole.

Not sure what you mean when you say not representative of the soc population as a whole Survior.

Removing either ends (longer and shorter lived) because of pseudo progessors being removed. I just want to make sure you are using the right %s.

I did not take into account the removal of the pseudo progressor patients. I thought about it since it would make the results even more compelling but figured I should keep it as simple as possible first pass.

Also I came up with 9 maybe 10 per month in the last 12 months enrolled, 3 the last month, small difference.

I did 165/16 months going from May 2014 (100) to Nov 2015 (331 full enrollment) and got 10.31 per month. If I add a month on both ends it is 165/18 which is 9.16 which is more in line with you. If I get a chance I will try it with this, but I am guessing it won't make much difference.

Do you have another more similar population to use for survival %s, like ict 107 control or others that accounts for removed psuedos? NWBO has more than the 331 to look at, although some are blinded(331) and some are not, they know the start and end dates of each individual patient.

I am open to looking at another population for comparison if you have one to recommend. I was mainly just try to keep this a simple as possible to see if we were in the right ball park.

AVII's stats also assumes hazard event rates that are proportional without delayed separation and this underpowers his results, doesnt account for long/fat/flat tail. A soft landing if you will.

]If I recall I think he is he is also still trying to compare the 2/3rd DVCAX patients to the 1/3rd Placebo then DCVAX after regression which if the whole cohort is living longer may prove challenging to demonstrate statistical significance. It is hard to know from public data.

In example if a placebo and treatment arm both had an mos of 18 months yet separation occured after and twice as many people were alive at 3 years in the treatment arm than this would be meaningful to patients. Stopping a trial early wouldn't capture this. Could it be they are looking at capturing landmark survival %s. If you almost double your chance of living at 2 and 3 years, I beleive this magnitude of difference would be stat sig and very simple to explain to the FDA, doctors, patients, investors, the st. Also the benefit in survival %s would presumably increase at 4, 5 and 6 years(more essentially "cured" pts). But we will never make it that far for all 331. They did say a slowing event rate.

Yes I think the slowing rate is likely. Again I tried to keep is simple and conservative (pessimistic). If the rate is slowing significantly we will all die of old age waiting for the very best result :-).
It is time to cut and run IMHO.