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DewDiligence

02/28/11 2:01 AM

#115599 RE: DewDiligence #104035

Pharming/SNTS get FDA Refusal-to-File letter for Rhucin in HAE:

http://finance.yahoo.com/news/Santarus-and-Pharming-bw-1473998633.html?x=0&.v=1

Inasmuch as the FDA is requiring results of a phase-3b trial as a condition for resubmission of the BLA, it’s reasonable to infer that the companies knew of the pending rejection when they announced the start of the phase-3b trial a few days ago (http://finance.yahoo.com/news/Santarus-and-Pharming-bw-1313301398.html?x=0&.v=1 ).

Pharming and SNTS inked a deal to co-develop Rhucin for the US market in Sep 2010 (#msg-54323285).