NorthWest Biotherapeutics Inc (NWBO)

[Diamondjim61]

I think you are fairly close.

My hypothesis is the following. In mid 2015 at the IA the DMC looked at the data and it suggested that there would be no stat sig different between the two arms for PFS at the end of the trial. However the DMC allowed the trial to continue but with no more enrollment given the improving knowledge in the immuno oncology field about the confusion between progression and an inflammatory immune response through infiltrating T cells(what we actually want!). Then when they looked again in nov/dec/jan 2017 they could see it was just pseudoprogression and have lifted the hold. If that is the case then the DMC lifting the hold is almost like an admission that the PFS endpoint was a success since they are unblinded and looked when the 248 event limit had been reached.