NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

Umibe, Pioneering various regulatory paths may pertain to the possibility that median OS values of treatment may not be SS when compared to placebo and/or that NWBO was not able to reliably adjudicate genuine progression especially during the first part of the trial. Consequently, NWBO may have to rely on differences in the numbers of long term treatment and placebo survivors (the long tail).

However, with respect to PFS I believe that not all is lost. You probably remember, that the 248 progressing patients (75% of the trial) were only announced at 2/17, about 36 months after midpoint surgery which I estimate had occurred around 2/14. They knew that most of the 248 had progressed by 2/17 simply because about 223 patients (less LTFU) were already dead by 3/17 (108 were alive). If there were 11 LTFU only 212 were certain to be dead. So all the 212 dead patients had progressed and it was easy to establish progression of 36 PFS patients who were part of the about 108 who were still alive.

I would also like to say that at 2/17, 25% of the patients had not progressed and that is remarkable since this was established 36 months after midpoint surgery which I estimate at 2/14. I think that this bodes well for the trial.

Furthermore, pioneering various regulatory paths with the emphasis on the word "various" may be appropriate because the FDA, NICE, EU etc. may put different emphasis on the various results which this trial will produce.

Also, unblinding around 46 months past the last patient's surgery may not be quite so arbitrary mainly because the attrition rate of of the first 223 patients was found to have slowed down considerably at that point. Obtaining survival data at post 46 months surgery for the remaining 108 patients whose survival up to 36 months was the best, will make it easy to estimate the 5 year survival of the various groups in the trial (Treatment, placebo, methylated unmethylated).

Finally I don't like NWBO's lack of transparency anymore than anyone else. I believe that till the end this will be the defense mechanism they deem to be necessary for their survival. They have raised the policy of "loose lips sink ships" to a fine art.