I'll raise my hand and admit I thought anyone who said AMRN would go for a label w/o mention of a statin was nuts, the data did not include any patients who weren't on statins with LDL < 100 - I still think AMRN was nuts to ask for that label, but luckily the FDA bailed them out and will let the AC panel recommend it's own version of an acceptable label, which may be narrower than AMRN could have gotten if they asked for a more conservative one instead of the "V for everyone!" label. Not that it's really going to matter in the end, V will sell like hotcakes - but for insurance purposes it would be nice to get the TGs 135 or more on label, and I'm reasonably sure statins and well controlled LDL will be on it too, but don't think insurers will demand evidence of statin use.
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