NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

The prior Rindopepimut nGBM trials (prior to Act IV) did not use carefully assembled historical controls. IMHO. Just more post Celldex CYA. Remember when they were pumping just before (Act IV) results? Remember when AF stopped pumping just before results and instead started warning because he supposedly talked to "shorts"? "Uh oh"

Control did not outperform an appropriate historical control MRD in Act IV. Celldex is wrong about that, imo.

Anyway, I'm certain you must have read the appendix graphs. http://www.thelancet.com/cms/attachment/2109603664/2082976630/mmc1.pdf

Even with MRD surgery of 2cm or less, the PFS (**finally released by Celldex) was only 8.0 PFS (post randomization) in the minimum residual disease treatment (MRD) group and 7.4 in MRD control group. Not what they obtained in prior unmasked/never blinded trials, and far from exceptional.

Dr. Liau wants to compare blended Rindopepimut with blinded DCVax-L trial. Wonder why?

Now she can, because Celldex released the blinded PFS results (in addition to previously released OS), which were not anything like the prior trial that were not unblinded. Wonder why Celldex waited almost two years to release PFS.

Look at these:

ACT III (n=65)
12.3 p = 0.0088 (approximatey 9.3 months from randomization) (Note: ACT IV (a masked/blinded trial) was 8.0 treatment and 7.4 Control)

Act II (n=22)
15.3 p = 0.0029 (approximately 12.3 months from randomization) (Note: ACT IV was 8.0 treatment and 7.4 Control)

ACTIVATE (n=18)
14.2 p = 0.0112 (approximately 11.2 months from randomization) (Note: ACT IV was 8.0 treatment and 7.4 Control)

Matched historical control (n=17)
"6.4" !!!!! You call these Matched ?!?!?! Had they used the right historical controls of 1 cm or less historical matched controls, it would not have been 6 months. You expect us to believe 6.4 was the historical match against 9.3 to 12.3???

BTW those earlier trials were 1 cm or less residual disease, where Celldex was 2 cm or less residual disease.

**In my opinion, Celldex reluctantly coughed up PFS results after Dr. Liau said they were important to compare and contrast with the current phase III trial. It was as I suspected, lower than all previous results and what would be expected in a group for minimum residual disease.

You kept going on about the NWBO DMC chairman.....you know what? He is very very vocal about other companies releasing their results so other companies can make suitable comparisons. Celldex held onto to their PFS results long after releasing OS. It is now clear to me why they were reluctant. IMO.

It makes sense to me why Dr. Liau was/is advocating to compare DCVax-L blinded phase III with Rintega blinded phase III.