Replies to post #746008 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

None of those patients had received DCVax when the Baseline Visits were reported. So that single psPD patient in that group of 46 had psPD from the chemo/radiation he/she had received.

The trial had anticipated that there would be some patients who would develop psPD from the chemo/radiation (it had already been determined that chemo/rad sometimes caused this). That is why, initially, the trial was set up with a separate and randomized psPD arm. Then in September 2014, that arm was removed from the trial... and please note: the informational arm was separate. This was the group that never entered into any part of the trial as they were removed because there was evidence of what was thought to be real progression by the time they were to enter the trial and begin to receive DCVax-L. The evidence of progression made them ineligible to enter the trial.

So this informational arm provided no evidence that DCVax would cause psPD.

The P3 trial chose PFS as the PRIMARY ENDPOINT after they had all the evidence they could measure it.

I'm not sure what point you're trying to make from your quote cited above. PFS was chosen as the endpoint back in 2005, not in 2015 (see link to the trial history below). They changed the primary endpoint to the secondary of OS (which everyone on the planet agrees is the gold standard) when they suspected that the vaccine might be causing psPD, and while they were still completelyblinded to the randomized data.

https://clinicaltrials.gov/study/NCT00045968?cond=DCVax-L&rank=1&tab=history&a=3#version-content-panel