NorthWest Biotherapeutics Inc (NWBO)

[eagle8]

Hi Fosco1,

You said:

This being said, while often used in cancer trials, in this precise clinical trial, if PFS cannot show a significant benefit because of pseudoprogression or other causes which would not jeopardise overall survival, my concern is that crossover could jeopardise OS superiority demonstration.
It would be such a shame that an efficient drug could not prove OS Superiority and therefore prevent a huge number of potential patients to be able to receive it just because a few patients had to receive it.

Not so long ago Linda Liau (P.I.) told us in a presentation that from the top 100 survivals, most were without PFS. So they must be from the treatment group ( or most unlikely from the placebo without crossover).
So maybe a few crossovers, maybe none.
So OS is not likely in danger especially when they compare to Historical results. And also FDA confirmed (if memory serves) that comparison with historical results should be allowed. They changed the SAP for this probably.

Good luck.