Pooled 31-patient matter
I was expecting a stronger indication of satisfaction from you on the pooled 31-patient matter. Perhaps I’m emphasizing this unduly.
Sorry, but I didn't see why you thought this detail was so significant until I went back and reread your post #8364.
The 17 patients in the U.S. trial's active arm will be pooled with the 14 patients from the European study whose review is now pending, giving an effective active arm of 31 patients.
It is indeed a small coup, Dew, to be allowed to pool data and stack the odds for a favorable outcome with existing data from a similar, positive study. Maybe we should attempt to verify that Cox meant what he said.
But, I did not come away from the CC with your impression that 17 patients are necessarily going to be from the US. I heard Cox say that the new data would come from Europe and US. As I understand it, we can expect study arms as follows:
1)ATryn active study arm with 17 new patients from Europe and USA;
2)Historical control arm with 35 preselected patients from Europe and USA.
3) A total of 31 patients from USA and Europe will be compared to 35 historical controls from USA and Europe.
Is there more to it than that?
