NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

To those who believe it's possible to unblind the trial, but continue to work on the SAP, think about it. How different would that be to going to a race track with all race results know, imagine how much you could make with just a $2 bet in the first race.

Someone mentioned needing the IRB to sign off on the SAP. As I understand the IRB's function, they formalize the trial protocol beyond what's presented in the IND. If they do have a function in the end if a new SAP is being prepared, I'd appreciate it if someone could explain that function.

If in fact the draft SAP has been commented on by the regulators, and revised to incorporate any recommended changes, then we should be very close to a submission followed by unblinding the trial. On the other hand if the Draft is just now being provided to the regulator for comments, I would believe they'd get at least a month, and probably longer to review it. Let's say they get 60 days, the approval wouldn't be documented, if nothing was said after 60 days it would be a presumptive approval, essentially the same way that IND's are approved.