NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Correction to my last post:


The sentence in bold was pasted after the wrong paragraph in the last post.


This is the correct version,

IMHO, there was a degree of timing placed into the trial.

The timing is a bit off, so the world has to wait.

If the Pseudo-progression enrollment didn't start until 2011 or so, then it may be the 72 spaces they added to the trial are for the them.

Do some very simple math.

Ultimately 240 in the main body.
Ultimately 112 events required for final analysis
66 required for 1st interim analysis.

72 in the alternative group (pseudo-progression)
Ultimately 33 events "desired" for final analysis.
19 "desired" for 1st interim analysis.

If you met the primary endpoint in the main body, the pseudo-progression group is not an afterthought. They are just as important, and you would want to analyze the results before you unblind the trial. You would not want to neglect this very important group, and even though they are analyzed separately, ultimately you would want to also determine how both groups did as a whole. This would explain why they are telling us efficacy data analysis is pending.


If you were simply going to continue the main body of the trial, you could simply do that and analyze the pseudo-progression group at the second interim analysis for the primary group. You would not wait for the pseudo-progression minimum events at the 1st interim analysis in this situation.


Finally, there would be simply no reason to halt the trial for futility at the 1st interim unless the results on the primary group were showing a statistical detriment (which would be a safety issue -- and there is no safety issue) to the patients. Thus the safety continuation is more meaningful at the 1st interim than perhaps any other time when you have a very safe treatment.

-- Flipper