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Replies to #96906 on Biotech Values
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DewDiligence

07/28/10 6:18 AM

#99961 RE: DewDiligence #96906

FDA grants priority review for Merck KGaA’s Cladribine in RRMS:

http://www.reuters.com/article/idCNN2720940320100727

The PDUFA date is on or about 12/5/10 (Merck KGaA is not disclosing the exact date).

A decision on Cladribine from the EMA is expected in 3Q10. The MAA was submitted in Jul 2009 (#msg-39836037).