I see nothing close to this. The -3 trial was not stat sig in the ITT population, and the -4 trial was called not-robust, and having a different characterstic post trial size change. And I see not even a hint of positive recomendation from the stat guys.
I do assume you are talking about the FDA's briefing document, not Dyax's wich was what genisi link to?
From the FDA: "Issues identified in the phase 3 studies suggest that there is a lack of consistent and substantial evidence to support the efficacy claim of ecallantide."
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