EMA is streight forward and firm in their decision - VVUS cannot pass the EMA approval process although they got FDA approval (which was pursued more politically then clinically). Eventually Doc's in USA disapproved FDA recommendation in support of the safety and efficacy of Qnexa. Finally VVUS plunged ....EMA was right at first place.
Now, ISIS may pursue 10 times with EMA and Sanofi can use best political influence from Paris but EMA will stand to their decision. For USFDA it is still in Limbo by Advisory Panel and FDA do not have sufficient data to approve Kynamro/mipomersen. While the FDA seems pleased with the risk/benefit profile of lomitapide(AEGR) for HoFH so ISIS lost this bettle for sure.