NorthWest Biotherapeutics Inc (NWBO)

[TZOR]

If the FDA stated that OS in small trials is open to flukes then we should be better suited with PFS as our primary and OS as secondary as PFS is apparently less prone to flukes. The trial size was also an issue relative to the fluke aspect. So if you increase the size you reduce the probability of a fluke conclusion.

Positives to take away
We already increased the size of our trial (compared to our prior size, we have reduced the possibility of a fluke conclusion)

We have PFS as a primary outcome (FDA apparently views PFS as valid or in the case of small trials more superior to OS)

We have OS as a secondary outcome (OS is still an important outcome to evaluate/test)