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Monday, 02/04/2008 4:40:05 PM

Monday, February 04, 2008 4:40:05 PM

Post# of 257268
GTC Reports Positive Top-Line Results of
Phase-3 ATryn Trial in Hereditary Deficiency:

#msg-26535139

ATryn was non-inferior to plasma-derived antithrombin, which was the primary endpoint of the study. (Please see #msg-25307567 and #msg-25866013 for details of the study design.) If there are no undisclosed glitches, these results ought to be sufficient for FDA approval of the ATryn BLA in late 2008 or early 2009, assuming a BLA submission in mid 2008.

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