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DewDiligence

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DewDiligence

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Re: DewDiligence post# 5177

Sunday, 01/13/2008 6:05:09 PM

Sunday, January 13, 2008 6:05:09 PM

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

[Based on GTC’s 7-Jan-2008 PR (#msg-25781631).]

January 2008: Complete study; report top-line results; begin “rolling” BLA submission.

1Q08 (presumably after the reporting of top-line data): Announce partnership for HD indication and AD indication(s).

2Q08: Report antibody data to FDA; 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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