The pregnant patients were excluded after the fact because the agency was concerned that the frequency of blood draws + infusion adjustment + re-test of the blood levels immediately after (near delivery) was too high in order to effectively manage the antithrombin levels. As such - that the treatment regimen from these pts was let's say, "impractical", those patients were excluded. Once that was done, the remaining number of "legitimate" trial participants was deemed inadequate in terms of providing enough data for a decision.
This was just covered again as part of a question.
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