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Biobillionair

09/18/13 3:08 PM

#14280 RE: sts66 #14265

My opinion was it couldn't be accepted with Lovaza's last Patent standing, that's not an issue now. By default, Epanova lucks out and gets to enter first with Fatty Acid twist compared to ethyl ester. Lovaza's last patent covered FA's thus blocking an Epanova 505 B 1 or 2 app. Whether or not the FDA is prepared to give Epanova 5 yrs for FA vs. Ethyl Ester is unclear. What is clear, if Amarin gets ap'281 AZN will be paying Amarin royalties for Epanova;)

Epanova still has to prove full safety, remember DHA levels are multiples higher than Lovaza, this may give an uncomfortably high LDL considering Vascepa's on the market already with no LDL bump. Epanova approval is a true 50:50.