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DewDiligence

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DewDiligence

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Re: genisi post# 106122

Friday, 11/26/2010 3:28:49 AM

Friday, November 26, 2010 3:28:49 AM

Post# of 257251
FDA review of Cladribine extended to Feb 2011:

http://finance.yahoo.com/news/EMD-Serono-Announces-prnews-1755440006.html?x=0&.v=1

All told, things are not looking good for this MS drug from Merck KGaA. It was rejected outright by the EU in Sep 2010 (#msg-54812455). In the US, Cladribine received an RTF letter in 2009; Merck KGaA resubmitted the NDA in Jun 2010 (#msg-51012919) and surprisingly received a priority-review designation from the FDA. However, the FDA’s new 3-month extension for completing the review effectively nullifies the priory-review status.

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