NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

There's a chance that it could be shown to be safe and as effective as standard of care, but then I doubt it would be put into use. In addition, there's a chance that it could trend towards being better, but not be significantly better. In this case, potentially an argument could be made, if there are potentially good reasons why it did not reach significance. We need to keep in mind that our determination of alpha < 0.05 for statistical significance is arbitrary. This means that there is a 5% risk of concluding that a difference exists when there is no actual difference. In other words 95% of the time what you perceive is not happening by chance alone. An alpha of 0.1 would mean that 90% of the time it's not by chance alone. That sounds pretty good still right? I think so, but many doctors get hung up on a P value <0.05.

First, the trials is an add-on to SOC. If it is "as effective" as SOC, then it is not effective at all. So could never be approved.

Second, the alpha allocation issue is fuzzy. Is it .02 for PFS with OS being only sequential at a subsequent .05 (which is how the protocol read to me). Have they changed it, or was this never the case? Nobody knows.

And lastly, you also fall into the alpha trap. The P value does not state what you just asserted. It states that there would be a 97.5% chance that a placebo would not reproduce the same benefit (or larger) in the same trial. [Maybe your were just keeping it simple here. But this is one of my two pet peeves. Other being when people assert that a trial that failed to show a benefit showed no benefit]