GTC Biotherapeutics (fka GTCB)

[DewDiligence]

U.S. ATryn Development Timeline for HD Indication

[Based on GTC’s 4-Feb-2008 PR (#msg-26535139).]

Feb 2008: Enroll and treat the “17th” (last) patient in the ATryn arm. (The study has met its primary endpoint regardless of what happens with this patient.)

Mar 2008: Announce US partnership for HD indication and AD indication(s).

May/Jun 2008: Report 3-month antibody data to FDA.

Jun/Jul 2008: Complete BLA submission.

Aug/Sep 2008: FDA decision on priority review (probably 45-60 days after BLA submission).

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