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Saturday, March 15, 2014 11:13:12 PM
I should not have pulled a number for compassionate use out of my foggy memory. 200 sounds awfully high to me now. I just emailed NW's PR person and asked about both German knowledge of P3 and about the numbers for compassionate use. But I don't really expect them to say anything further about Germany's knowledge of P3.
But I agree about the timing being just to perfect to not be P3 information of some kind getting to Germany in some way.
One possibility that I think Flipper has pushed the most (my apologies to others if I am wrong) is that they finished the analysis with one patient subset, but are waiting for more events to satisfy the powering for another subset(s).
According to Flipper, Germany excluded one subset for their trials. Can't remember the name of the subset. It sounds like a feminine hygiene product so I don't want to try and guess wrong. If that is the remaining subset, then for Germany's purposes, the DMC is done. This would allow Germany and the US to continue that subset without a placebo, and of course it would have given Germany assurance of the validity of the therapy. I think the ability to eliminate the placebo may have been part of what Germany was waiting for and hoping for. That would be wonderful news for patients.
Linda Powers, however, in recent PR's continues to talk about a 2015 release of trial data. But if the trial continued blinded, but without the placebo... that would still be the correct date. So... it still makes sense. No money from the US clinicals yet then, but I don't think that would matter much at that point.
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