NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Evidently, FDA halted the trial prohibiting the company from screening new patients in order to protect new patients from being harmed. Note any regulatory agency would not wait for the company to prove otherwise if they deem patients may experience harm

So the FDA informed NWBO there were excess PFS events in the treatment arm. And that would mean the original primary endpoint was futile. Thanks for pointing this out.

To get the trial halt lifted, the burden obviously fell upon NWBio to prove. NWBio's opinion obviously is there is no harm to any participated patients for the reason of pseudo-progression. Evidently in Feb 2017, FDA agreed with the company. As a result, it lifted the halt.

No, the halt was for screening only. NWBO resolved this by declaring enrollment was complete.