Even the Feb '17 PR implies an event driven completion, though then at 233 OS.
That events continue to collect as the scrub goes down is the norm in event driven trials. That is why most trials end up with somewhat more events than planned.
I simply fail to see how anybody can look at this trial and not see it was event driven to 248 PFS, then changed to 233 OS, then unknown.
It is OK though. Even if RK is right then data on all patients will be complete by 2030 or so. And the phone bill for OS follow will be trivial. Not long :-
You may have forgotten that I’m actually the one who transcribed Linda Powers’ 2014 speech. Been back then she was consistent in letting us know the statistical analysis would be done at the end of the trial.
“Very importantly, in the latter part of the year we had some regulatory enhancements to the trial, which allow us to add some factors to the statistical analysis at the end of this trial. Nothing changed about the eligibility for the trial. Nothing changed about the treatment in the trial. But by adding these factors at the end of the trial, counting more events, and adding factors, we were able to significantly de-risk the trial. “ — Linda Powers 2014 Oppenheimer speech.
“Now, I want to go through some of the highlights in each of those two programs. It's been a very busy year. We're proud of this year and had a lot of major milestones this year. But most importantly, besides those milestones in and of themselves is, those milestones position us for really exciting 2015. So our DCVax Phase III trial for brain cancer is our lead program. It underwent a major expansion across the U.S. and in Europe. We had a safety-only evaluation, of the, by the Data Safety Monitoring Committee. Very importantly, in the latter part of the year we had some regulatory enhancements to the trial, which allow us to add some factors to the statistical analysis at the end of this trial. Nothing changed about the eligibility for the trial. Nothing changed about the treatment in the trial. But by adding these factors at the end of the trial, counting more events, and adding factors, we were able to significantly de-risk the trial. For example, in order for it to be a successful trial, we need only to show, instead of showing a six-month difference in the time to tumor recurrence, in patients who receive DCVax and those who don’t, we only have to show four-month difference. That’s a big lowering of the threshold for success. We actually think we’re going to show a much bigger difference than that, because in our earlier stage trials we showed a year-and-half of difference, not six months, not four months. We tried to design this trial to be very conservative and to maximize the chances for success. We had to get separate regulatory approvals from the U.S. FDA the German regulator in the UK regulator - all three, in order to make these changes and we were really excited to achieve that. “ — Northwest Biotherapeutics – Linda Powers’ Speech Transcript at the Oppenheimer 25th Annual Health Conference on 12-10-14.
Here’s the entire speech so you can see I haven’t doctored it!
I think you took her words about the finish lime to mean statistical analysis. But it doesn’t. Instead it means the primary endpoint threshold finish line on that Phase III trial. Stated another way she meant this:
“Taking into account the time required for these approvals and implementation steps, and the 36-patient increase in the trial, as well as the gradual ramp-up of the trial in Europe, the Company currently anticipates that enrollment will be completed in approximately Q3 of next year, and the primary endpoint of the trial will be reached about 3-5 months after full enrollment or by around year-end next year.” NWBio August 2014
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