NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Going back to the vexed issue of Grade 3/4 SAE's. If it was the case that there were two such incidents in the Phase 1 Direct trial as has been reported, and the investigators believed that Direct vaccine was the cause, they would come under a requirement to report this immediately to the FDA, I believe. And the FDA would presumably make further investigation about the advisability of continuing the trial.
If on the other hand, it was believed that a previous or concurrent drug treatment was responsible then there would be no such requirement. Would I be right in this assumption?
I guess Conference will enlighten us.