NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Yes, I think there probably was one IA that looked at efficacy.
But I don't know when.

It's tempting to think that it took place in July/Aug '15 and had some bearing on the decision to impose the hold (on further randomization to control) a week or two later.
But equally it could have been earlier (if indeed one has happened).
I'm still trying to locate in time the Doc Bosch comment about the pseudo-progression issue wreaking havoc in immunotherapy trials in general. Maybe it was the ITOC meeting in Germany (March 2015)
I do recall LP denying that an IA looking at efficacy had taken place, when AF was asserting that they had had one and that the trial had failed. That was Aug 2014, when her statements were fully backed up by Curt Furberg, the Chair of the DMC.

After that, I recall that LP said in a PR something to the effect of 'we will be doing an efficacy analysis later in the year' but for the life of me, I can't find that reference now.

In any event, something told them that PFS adjudication was necessary, because otherwise, why do it?

Then there is the old chestnut about whether, if the primary endpoint fails, any analysis of secondary or tertiary endpoints gets relegated to fact-finding, but is not usable for approval purposes. Or is that myth (in this case)?
And what 'independently powered' actually means in practice.

If the alpha is actually equally split what does that mean?


Questions, questions..