NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

2 quick links. See you in a couple days.


Sequential Analysis is one of the keys to understand how the DMC is likely to analyze this trial in each separate interim review. IMHO



http://www.ncbi.nlm.nih.gov/books/NBK13920/


http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=0CDgQFjAB&url=http%3A%2F%2Fpeople.musc.edu%2F~elg26%2Ftalks%2Finterimanalyses.ppt&ei=RKjXUraFL9bdoATirYDgDg&usg=AFQjCNEqt7MTIOp6hap81pOMEGiLjQT5Ig&sig2=DrAQ1t2FVvzcoXldpA7LXg&bvm=bv.59568121,d.cGU

Stopping Rules:

Since the DCVAX-L two arm expected P value for the final review is .02 (instead of .05), for various reasons (I won't go into here), I believe/speculate the 1st interim review of PFS will demand about a .0001 p value in order to unblind the trial. I am only starting to understand this science, so take my estimate with a grain of salt. I would gladly take correction/redirection from a statistician.

(Had there been three interim reviews (there are really only 2 in our case) prior to the final review, I believe the 1st interim p value would have demanded a .00001 p value to unblind the trial).