NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Bio,

It's my understanding that a trial can be stopped early if the DSMB monitoring the trial goes to the regulators independently. If after discussions they're told to continue the trial, I'm uncertain if anyone ever knows that the regulators were contacted. I can't say if this may ever have occurred in the trial.

I believe that if the DSMB goes to the regulators and they agree the trial should be stopped, the regulator expedites the approval of the product. I frankly don't know of many times this has occurred, but believe Gleevec was one of them.

I don't know if at the time the trial was halted it could have had anything to do with this, but one thing seems sure, the German's were aware of the benefits being seen and pushed for all to get the vaccine from that time on. I would suspect that at times the clinicians may have taken actions similar to what DSMB's are responsible for, but I can't say that's the case.

I would suspect that far more communications occur between the regulators and others involved in trials but the only time the regulators will say anything is if their position isn't properly represented. If companies don't discuss what's happening with the regulators the regulators won't say a word, and they only will if the company misrepresents anything communicated between them.

Gary