Saturday, January 19, 2019 5:06:39 PM
Only 7 responders were available for DOR, the other 5 were censored.
Six of the seven measured responders had DOR > 6 months.
However since there were 12 initial responders they had to use that as the denominator: i.e. 50% of the responder were over 6 months.
I look at the data for prediction purposes, not for stringent filing purposes.
So. If only 7 patients were available for actual DOR and 6 were over six months, I extrapolate that to the Zenith trial and predict that most of the responders will be available for DOR analysis (few censored) and that 85% will be over 6 months. Also some of the responders had not had an event at filing time. That's why I expect a DOR of 8+ months. 9 or 10 months won't surprise me.
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