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Biotech / Medical : GTC Biotherapeutics
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From: DewDiligence_on_SI2/4/2008 4:55:14 PM
   of 135
 
GTC Reports Positive Top-Line Results of
Phase-3 ATryn Trial in Hereditary Deficiency:

siliconinvestor.com

ATryn was non-inferior to plasma-derived antithrombin, which was the primary endpoint of the study. (Please see siliconinvestor.com and siliconinvestor.com 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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