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marzan

12/22/15 12:43 PM

#67406 RE: rafunrafun #67395

Raf,

IMO, Govies only fear if you take them to court because of public negativity and potential congressional inquiries down the road. Here we already won but nothing materialized. So, unless you take them back to court, they will play games.
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exwannabe

12/22/15 1:50 PM

#67407 RE: rafunrafun #67395

I would think the obvious issue being negotiated is information printed on the lable.

This would be something outside the scope of what the Judge could reasonably do. And it is something reasonably tied to the core issue (unlike expedited review and/or NCE).

The lable is what separates Vascepa from fish oil. Non-lable marketing material just blurs the line.

I do not see the indication being expanded to Anchor. But perhaps some minor changes that bring in some claims.

EDIT: Also any label change would certainly need to be signed off by the apropriate staff review process, so could take time outside of court schedules.