Hi mac,
i can answer some of those, i know i'm not kbear :)
regarding DNDN i dont know so i will leave that to someone who does
regarding PFS...the phase2b trial isn't POWERED to see a significant effect on PFS, but, what you should still see, is an increase in PFS in the Cvac group compared to OSC. this suggests that there is an effect, and you can then calculate how many people it would have taken to turn the effect seen in the phase2b trial from a non-significant outcome into a significant outcome.
a simple example (making up numbers here).
if the OSC group was to have a median PFS of 300 days and Cvac group had a median PFS of 450 days, then the effect measured was 150 days, or 150% longer. The trrial would not have had enough people to make that significantly statistically, but it would have been long enough clinically, and then they could have calculated how many people were needed to prove it statistically
the fact PFS favoured the OSC is just bad...it could have been an unfortunate event, but ultimately, it will take some time from here to recover, both from the side of research, and share price
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