NorthWest Biotherapeutics Inc (NWBO)

[olekbolek]

maybe this is the issue of releaising tld - this is copied from yahooboard - origin is from investorvillage - was this discussed earlier here?

hodag:
The Checkmate-548 (BMY's) overall survival results were presented at SNO. Placebo overall survival from randomization was 32.1 months. Those placebo patients off steroids saw 33 months. Compare this to DCVax-L at 34.7 months from surgery for MGMT+ patients. Note that for the Checkmate trial patients needed to have recovered from surgery before being randomized. But, there was, of course, no exclusion of (rapid early) progressors after primary chemoradiotherapy (along with many other things for the vaccine). Also, in the Checkmate trial there was a requirement for only 20% or greater surgical resection. Again, very different from DCVax. The results are again entirely consistent with the vaccine doing absolutely nothing.

Now that these results are published I would love to see NWBO explain how 34.7 months for DCVax (in MGMT+) is statistically different from 32-33 months for the placebo group in the Checkmate trial. I can tell you that with the sample size available to work with in NWBO's trial that will be a mathematical impossibility (Checkmate had just shy of 700 enrollees). The numbers are not your friend in this case.

Another thing, to gain an approval in the real world the performance of any new treatment must be compared to the performance of an acceptable comparator. So, in this case, the "top 100" is not a comparison to anything randomized and controlled, it is just a rank-ordered list that includes all patients in the trial and thus does not provide a basis for an approval decision. Believe what you want, but "hey, it looks good to me" has never be the basis of a new approval!

.....