NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

There is a fundamental concept in trials called multiplicity and alpha spend is used to control it.

Say you have a trial. Look at one endpoint and it is not P<..05 so you go to the next, then the next. Eventually one works by pure luck. Alpha spend is how you account for multiple endpoints. In this trial the design was that PFS was the primary. If, and only if, it was stat sig then OS would be evaluated.

NWBO learned that PFS failed in 2015 based on the IA (anybody who does not know this is delusional). And so they then changed to OS. That is a basic formal no-no.

That said, the FDA and others may well accepted OS as defined (233 vs 99). But that also failed (and again, anybody who does not know that is delusional). So they changed again to OS vs external controls. But now the issue gets far worse as it is not just a third shot on goal; but also goes against much of what the FDA says in their guidance on how to use ECAs.