NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

doingmybest,

That is what I believe is taking so long. There may or may not be a dilema here that must be solved internally at FDA with regard to what I believe is a very data rich trial. There may have been enough built in flexibility for the trial to move to mesenchymal subtype emphasis at resizing if desired. If spectro analysis data was gathered from tumor samples beginning at some early point in the trial then that could be presented to support a look at mesenchymal subtype within the context of the entire patient group. If 28%-50% newly diagnosed patients are primarily mesenchymal this might keep PFS closer than desired but if 80%-85% express mesenchymal at recurrence then effect from treatment could be showing a clearly greater effect. FDA would clearly have trouble defending a too bad so sad decision if evidence of benefit is clear enough and PFS and OS are showing positive trends but.. there is that disclaimer about the decision being in the hands of regulators. On the other hand, PFS could be a non issue. PFS may be good enough already or the Germans may decide to allow the HE program move forward based on OS alone depending on analysis. Or, as flipper44 has pointed out, the recently identified prognostic indicator that can identify patients who can benefit from DCVax will make the wrong regulatory decisions very costly for regulator reputations. I am sure they are checking all the data for proof that this indicator is accurate. If it is.. well we will wake up one morning thankful for a breakthrough. I think AVII77's recent posts indicate that he has seen the light.