NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

I looked up "Surrogate Endpoint". The term fits DCVax-L because PFS is surrogate for OC. That's all. Has no meaning for us here. One can just ignore it in the text you quoted.

What is meaningful is that the trial can continue while you are asking the FDA about early termination. When I suggested such in the past I was shot down. Someone said the trial had to halt in that circumstance.

But they also argued that the DMC can not be petitioning for early termination without involving NW. That it doesn't work that way. I do wonder if they could walk the line and leave just Les Goldman and Linda Powers out of the loop. Seems unlikely. Seems more likely they would be asking for a clarification of some sort from the FDA.

I do have one possible explanation for why they would talk about expanding (not necessarily extending as you point out) the trial:

I believe Germany will only be gathering data for the eventual PEI approval (or not). I believe that they will not have a placebo and will therefore not be contributing, as had been planned, to the US/FDA trial. While expansion in Europe might work to fill the gap, it is more straightforward to expand in the US, because other European countries might fall in line with the German policy. Certainly the UK. That expansion in the US will have to start very soon if they do not get an early approval. In order to explain any reports of such US expansion activity... they say, "We are considering expanding the trial." when in fact... they are just moving the US/FDA trial back to being 100% US.

All speculation, but this makes the most sense to me.