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).