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Wednesday, November 18, 2015 11:09:14 PM
Everybody knew about this arrangement when the FDA and the Europeans aligned the trial plans. Either both regulators are willing to judge the confirmatory on PFS, or it is believed that the crossing over, while giving some hope, does not elevate the control arm OS enough to destroy the chances of full approval based on OS. It must be one or the other.
At least... that is my guess. Do you think the FDA and the EMA would maintain different ultimate approval criteria?
What if DCVax-L is approved in Europe and not the US? How many Americans could afford to fly to the UK, or Germany for the treatment.
More likely the UK since less stress, being the same language. That would take quite the infastructure in the UK, if many Americans were to fly over... Quite the infastructure.
What value $NWBO if European approval only. Note that even European approval likely ensures enough income to accelerate plans for DCVax-Direct, which is worth 10 fold what DCVax-L is worth by most people's estimates.
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