hoe zien die eruit "modulators" is dat biotech?
popie
Halt Date Halt Time Issue Symbol Issue Name Mkt Reason Code Date Resumption Quote Time Resumption Trade Time
01/09/2009 12:57:48 GTCB GTC Biotherapeutics Inc. N T1
1:30 p.m. Topic II: GTC Biotherapeutics Inc. Biologics License Application for Recombinant Antithrombin III Derived from Genetically Engineered Goats for Treatment of Patients with Hereditary Antithrombin III Deficiency to Prevent Thrombosis During High Risk Situations like Surgery and Obstetrical Procedures
A. Introduction, Nisha Jain, M.D., DH, OBRR, FDA (10’)
B. GTC Biotherapeutics, Inc. Presentations (60’)
i. Introduction, Richard Scotland, GTC Biotherapeutics, Inc.
ii. Recombinant Antithrombin Production Process – from Gene to Product, William Gavin, D.V.M., GTC Biotherapeutics, Inc. and Carol Ziomek, Ph.D., GTC Biotherapeutics, Inc.
iii. Atryn Clinical Program
- Hereditary Antithrombin Deficiency, Stephan Moll, M.D., Ph.D. University North Carolina Chapel Hill
- Clinical Trial Results, Johan Frieling, M.D., Ph.D. GTC Biotherapeutics, Inc.
C. FDA Review of Manufacturing, Roman Drews, Ph.D., DH, OBRR, FDA (30’)
D. FDA Review of Clinical Data, Nisha Jain, M.D., DH, OBRR, FDA (30’)
3:45 a.m. Break
4:00 p.m. Open Public Hearing
5:00 p.m. Open Committee Discussion
E. Questions for the Committee
F. Committee Discussion
6:00 p.m. Adjournment