GTCB is trying to show non-inferiority of rATIII to plasma derived ATIII. What we need to know is what percentage of HD patients given plasma derived ATIII had a symptomatic DVT. From the European trial of rATIII, we already know that zero patients out of 14 HD patients had a symptomatic DVT.
Vinny
P.S. Jesse, you are right on the money with the stupidity of having to conduct European and US trials of the same drug. What a waste!
I like to keep it simple. There's a 95% likelihood or greater that if Atryn doesn't cause symptomatic DVT then it will be found non-inferior. It's a lot lower bar than trying to show superiority. It's like being a midget in a limbo contest whose goal is not to lose. I like the odds and I've got my money on the midget. Why shouldn't it work? I'll bet GTCB is negotiating their pants off trying to cut a good deal with a much bigger pharma and attempting to avoid getting steamrolled in the process. Its called dancing with elephants without getting squished. The biggest risk I see is a partnership deal that isn't as sweet as investors hope for, but at least insures survival. The current share price creates doubts. Fortune favors the brave little people.