NorthWest Biotherapeutics Inc (NWBO)

[j e d]

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.

You're completely missing the point--"PFS events" at that time included pseudo-progression. As Dan said, although "it's inherently a good thing, it may wreak havoc with PFS as the primary endpoint." So IF pseudo-progression doesn't exist, and all those that progressed were actually progressing and not experiencing pseudo-progression due to an immune response, then yes the original endpoint would likely be futile. BUT, there is clear consensus in the field that pseudo-progression exists, hence the lifted halt and endpoint change.

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

Reread the paragraph again:

"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. 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."

He says pretty clearly the halt was for screening only. NWBO's rebuttal was that patients were not being harmed. Upon review and acknowledgement of pseudo-progression they were found to be correct and the halt was lifted.