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DewDiligence

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DewDiligence

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Re: genisi post# 86834

Tuesday, 06/08/2010 3:43:22 AM

Tuesday, June 08, 2010 3:43:22 AM

Post# of 257253
Merck KGaA resubmits Cladribine NDA in RRMS:

http://www.reuters.com/article/idCNLDE62O0CG20100608

The FDA issued a Refusal to File letter in Nov 2009 in response to the original NDA submission (#msg-44040202). Merck KGaA refused to divulge what the problem was, leading to speculation that the FDA had insisted on another phase-3 trial (#msg-46949655, #msg-46954975).

Merck KGaA expects a ruling on Cladribine from the EMEA in 3Q10.


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