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DewDiligence

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DewDiligence

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Re: DewDiligence post# 5027

Friday, 10/12/2007 7:50:43 AM

Friday, October 12, 2007 7:50:43 AM

Post# of 19309
U.S. ATryn Development Timeline for HD Indication

[Based on the guidance from the BIO webcast this week.]

4Q07: Complete study; report top-line results; begin “rolling” BLA submission.

1Q08: Report antibody data; complete data analysis.

Mid 2008: Submit final module of BLA.

Late 2008/early 2009: FDA decision on BLA (assuming a six-month priority review).

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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