>Dew, since Japan is now coming more in the [ GTCB ] picture, are you familiar with what is required to get approval in that market. The CC was a bit vague on this, sometimes FDA or EMEA approval will do but "some" clinical development is usually necessary.<
I think the answer was vague out of necessity because there have been no conversations between GTC and the Japanese regulators. My guess is that the Japanese Agency will accept the comprehensive safety data from the U.S. and Europe, but will require a modest-sized head-to-head trial of ATryn vs plasma AT to see if the rates of DVT are comparable. Again, this is just a guess and the Japanese could end up requiring more than this, or less.
>Another question, do you ever sleep?<
Yes—I did between 10 a.m. and 1 p.m. today :-)
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