NorthWest Biotherapeutics Inc (NWBO)

[MolBiol]

How exactly do you just blindly decide to increase the size of the trial? I mean do you just wake up one morning and have a gut feeling that you just need a few more patients in the trial to get to where you need to be for licensure? I'm pretty certain that one of the roles of the steering committee or DSMB or both is to make such recommendations based on the data. They can't unblind to the practitioners or the sponsor so as to change how the trial is being conducted, but they can see for themselves that the trend line is separating from control, but maybe not enough to be statistically significant with 312 in the trial. So, they recommend enlarging the trial. Linda made the point in a roundabout way that if PFS is short of 6 mos they might/would need a more stringent p-value. Can someone please explain to me how you come to the point of even discussing enlarging the trial without some news that you might need too? I've never heard Linda say that "they are thinking about it". I've only heard her say that they could if needed enlarge the trial.

My guess is that at this first interim look there is a trend that is positive but may not meet the endpoint. If you are going to change something you do it now rather than at the end. I don't know, I'm totally puzzled by this. Fox..do you have any thoughts you would like to share?