The lipid changes in V arm mean nothing more to PCPs or FDA now than they did after ANCHOR. Can you believe physicians still prescribed gen Lovaza twice more than V six years after ANCHOR despite LDL-C jumps with L? And despite an aggressive sales/education campaign. Can you believe they still are, weeks post AHA and the NEJM pub, and two months since topline? I guess we’ll see what the next few months brings, but you all may end up surprised and claiming “malpractice!” at that time.
AMRN will continue working on the massive sNDA filing and submit it early next year, and may just get priority review. I think they’ll probably end up getting approval, but FDA has issued many an eye brow raising CRL before. They certainly still could here.
AVII brought up the DCTH CRL, know anything about that? I think it was crazy, but that’s FDA for you. Just never know.
GL
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