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Wednesday, September 19, 2007 8:57:09 PM
Clinical, Preclinical Goals for 2007-2008
[The CD20 program has been added and
I’ve updated the accompanying notes.]
Notes:
1. The European marketing launch of ATryn took place at the International Society of Thrombosis and Hemostasis conference in July 2007.
2. Commercial sales of Atryn commence according to the timing of reimbursement negotiations on a country-by-country basis.
3. In the phase-2 trial in DIC, the first patient was enrolled on 8/6/07 (#msg-21836554). Full enrollment is expected to take approximately one year.
4. GTC’s submission of the ATryn BLA to the FDA is expected to occur in late 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).
[The CD20 program has been added and
I’ve updated the accompanying notes.]
Notes:
1. The European marketing launch of ATryn took place at the International Society of Thrombosis and Hemostasis conference in July 2007.
2. Commercial sales of Atryn commence according to the timing of reimbursement negotiations on a country-by-country basis.
3. In the phase-2 trial in DIC, the first patient was enrolled on 8/6/07 (#msg-21836554). Full enrollment is expected to take approximately one year.
4. GTC’s submission of the ATryn BLA to the FDA is expected to occur in late 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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