NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I don't remember anyone bringing this up, so I will. We all remember the European Clinical Trial sites were revised by the European agencies, NWBO was surprised at the time they did it. I believe that all regulators agreed on the same SAP, however in the European site what they I believe was to rearrange the existing goals, based on what the SAP indicated, but they didn't eliminate goals that may really not have been applicable based on the SAP.

NWBO was responsible for the update to Clinical Trials here in the U.S. and now that it's done, we can see only two goals, both are based only on Overall Survival of different groups.

I suspect that this more closely mirrors what's in the SAP, but the European's didn't wish to throw out goals no longer specified, so they made OS the primary goals, but the others remained.

I believe that in their submissions to the regulators they'll only address the primary goals, perhaps they'll note that the SAP only covered them. Here in the U.S. that shouldn't be necessary as all but the O.S. goals have been eliminated.

Gary