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BRIEF-EU requests more data for Gentium drug, approval delayed

Oct 10 (Reuters) - Gentium SpA :

* Receives second list of outstanding issues from the ema's chmp for

defibrotide maa

* Says the second list of outstanding issues has reset the ema's approval

timetable back to day 180

* Says plans to submit its response to the loois within 60 days, in line with

the new regulatory timetable

* Recommendation on approval of defibrotide is now expected in early Q1 2013,

based on the ema review process timeline

* Source text * Further company coverage

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