Aces I may be wrong here but I think Roy is just stating approval has not been graned as yet... I dont want to cause trouble but by your own quote approval is yet to be given
"Due to Mipomersen – successful Phase III in high risk cholesterol patients, The initial regulatory filings in the US and EU will result in approval, likely by mid-2012 and perhaps earlier based on SNY's projection that Kynamro (Mipomersen) will be launched by March 2012."
Notice "Approval, likely by mid 2012..."
next announcement and likely content, page-120
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