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rocky301

02/25/11 4:18 PM

#29740 RE: cty #29739

cty,


Could also be timed out for european orphan status update too.. By that time it will have been almost 90 days

If ACT filed around Dec.23rd when they PR'd the 90 day process would have started Feb 7, according to EMA Submission deadlines for orphan designations. So news by mid March would be unlikely.
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