"Not exactly—it’s the difference in dosing between the pregnancy cases and the surgery cases that caused the problem. However, none of this has anything to do with ATryn per se; the same variation in dosing would occur with plasma-derived antithrombin."
OK I've thought about this and now I don't get anything. This issue, the difference in the dosing was in the first submission. So what was the 2 years consideration including 2 delays about? The size of the surgical portion of the trial was known at first submission. None of this makes any sense. The only explanation I have seen that fits all the facts neatly is that they were concerned about transgenics, period. I really don't like to think that.
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