NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

MI D, remember when the trial began the primary goal had been PFD, patients who weren't on the vaccine were to cross over after progression. If it hadn't been for pseudoprogression perhaps the trial could have been judged years ago based on PFD with limited OS data.

We really still don't know how well we've done with PFD, whether patients who may still be alive, but were viewed to progress many years ago have been reevaluated and determined not to have progressed at all.

To me, this is the real flaw in the original trial design, effectively you lost the control group once progression was called. The company was wise enough not to chance that there was a significant difference between when progression was called for the control, and when it was called for those who received the vaccine up front. Perhaps it could have led to approval years ago, but it also could have led to a failure and we'd never really learn the survival advantage. The changing to OS as the primary goal was the right move, the only real question is whether they could have gotten the regulators to sign off earlier in the process. I believe the regulators took much longer to finalize the SAP than anyone thought they would. The FDA is changing, but change in the FDA makes a snail or turtle look like it's a supersonic jet in comparison.

Gary