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Tuesday, 01/11/2011 8:19:08 AM

Tuesday, January 11, 2011 8:19:08 AM

Post# of 92948
Per request, links and info re: Orphan Desig-Europe

(Announced Dec.23,2010)
Advanced Cell Technology Files in Europe for Orphan Drug Designation For Its RPE Cells for Treatment of Stargardt’s Disease
http://www.businesswire.com/news/home/20101223005366/en/Advanced-Cell-Technology-Files-Europe-Orphan-Drug


Submission deadlines table:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000037.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580024c5d&jsenabled=true

Note: In accordance with Article 5.5 of Regulation (EC) No 141/2000, the COMP will reach an Opinion on a valid application for orphan designation within 90 days. Please note that the dates provided above correspond to the COMP meeting falling on or just prior to day 90. Opinions may be reached earlier than day 90 if no questions are raised by COMP.

Compassionate Use: (Questions, Guidelines)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000293.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058007e691&jsenabled=true

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