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Sunday, June 03, 2007 10:27:42 PM
Clinical, Preclinical Goals for 2007-2008
Notes:
1. The launch of ATryn in Europe is scheduled for the International Society of Thrombosis and Hemostasis meeting in Geneva, July 6-12, 2007.
2. The enrollment of the first patient in the ATryn DIC trial is expected any day.
3. The submission of the ATryn BLA to the FDA has been pushed back to 1Q08. The FDA decision is expected in late 2008 or early 2009 depending on whether the FDA conducts a standard review (10 months) or a priority review (6 months).
Notes:
1. The launch of ATryn in Europe is scheduled for the International Society of Thrombosis and Hemostasis meeting in Geneva, July 6-12, 2007.
2. The enrollment of the first patient in the ATryn DIC trial is expected any day.
3. The submission of the ATryn BLA to the FDA has been pushed back to 1Q08. The FDA decision is expected in late 2008 or early 2009 depending on whether the FDA conducts a standard review (10 months) or a priority review (6 months).
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