Biotech Values

[DewDiligence]

FDA issues CRL for Cladribine in MS:

http://finance.yahoo.com/news/EMD-Serono-Receives-Complete-prnews-1074707575.html?x=0&.v=1

In the complete response letter, the FDA concluded that substantial evidence of Cladribine Tablets' effectiveness was provided by the CLARITY study. However, the FDA has requested the Company provide an improved understanding of safety risks and the overall benefit-risk profile either through additional analyses or by additional studies.

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 FDA RTF letter in 2009; Merck KGaA resubmitted the NDA in Jun 2010 (#msg-51012919).