NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Senti,

The initial SAP would have been the one established in Clinical Trials at the beginning of the trial. Revising Clinical Trials would update the SAP to what was submitted to the regulators prior to data lock.

In some ways they were rearranging the goals, overall survival was there before, it just wasn't primary. Few trials use OS as the primary goal as it makes the trial substantially longer to get some minimum time for all patients in the trial. I believe that when NWBO recognized that OS was their best shot at approval they knew they were adding years to the length of the trial.

I believe that if the DSMB ever discussed ending the trial early, they could have made a case for overall survival, even if it wasn't the primary judgement criteria at the time. I don't know if this ever happened, but if it did I'd bet it was because they saw many long term survivors in the trial.

Gary