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Wednesday, July 04, 2007 6:37:41 PM
Clinical, Preclinical Goals for 2007-2008
Notes:
1. The formal launch of ATryn is July 11, 2007 at the International Society of Thrombosis and Hemostasis conference in Geneva. GTC and Leo Pharma host a presentation on ATryn that includes talks by GTC’s Harry Meade and Prof. Mario von Depka of Medizinische Hochschule Hannover (#msg-20946121).
2. Commercial sales of Atryn commence according to the timing of reimbursement negotiations on a country-by-country basis.
3. The enrollment of the first patient in the ATryn DIC trial has almost certainly occurred. However, Leo Pharma plays its cards close to the vest and has not issued a PR to announce this milestone.
4. GTC’s submission of the ATryn BLA to the FDA is expected to occur in 1Q08. FDA action on the BLA 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 formal launch of ATryn is July 11, 2007 at the International Society of Thrombosis and Hemostasis conference in Geneva. GTC and Leo Pharma host a presentation on ATryn that includes talks by GTC’s Harry Meade and Prof. Mario von Depka of Medizinische Hochschule Hannover (#msg-20946121).
2. Commercial sales of Atryn commence according to the timing of reimbursement negotiations on a country-by-country basis.
3. The enrollment of the first patient in the ATryn DIC trial has almost certainly occurred. However, Leo Pharma plays its cards close to the vest and has not issued a PR to announce this milestone.
4. GTC’s submission of the ATryn BLA to the FDA is expected to occur in 1Q08. FDA action on the BLA 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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