NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

OS is gold standard

Placebo double blind for OS is the gold standard and because everyone including the placebo patients lived longer we are hoping the FDA or at least the UK regulator will create a new gold standard namely a blinded trial for OS with historical controls.

I believe in historical controls because they represent the real world results a new treatment is trying to beat and while placebo sounds good in theory for something like GBM they will never be ruthless enough to use it in a scientifically valid way.

But right now we are asking the FDA to formalize and retroactively employ a new gold standard to our treatment when we are an under resourced and politically unconnected company and it could adversely impact their BP partners.

This is a big ask and is still more likely than not to happen (especially if the UK follows through and that builds public pressure and awareness) but it is not guaranteed or quick and this explains our current SP.