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funnygi2

04/24/13 4:28 PM

#4986 RE: stangish #4985

I believe what you're referring to was whether the ANCHOR approval was linked to the outcome of the Reduce-It study. Agreed, they're not at all linked.

This is stating something else:

NCE will happen even if FDA has to change rules, they would have not asked for Reduce-it if generics could be on market at same time
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sharonc

04/24/13 6:35 PM

#4998 RE: stangish #4985

How would you know Omthera has to do an outcomes study when they have not yet filed an NDA? Do you work for the FDA?
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AtlasSnuggled

04/24/13 7:32 PM

#5001 RE: stangish #4985

Omthera should be informed that they will run a outcomes study. Cos they don't know about it , according to their webpage. http://www.omthera.com/clinical_trials.html and its the kind of thing they would want to reveal in case they ever run a good ipo.

They got a 6 week Add-on Epanova to Statin Therapy and a Pivotal 12-week Very High Trig planned, and a four-week Pharmacokinetics Epanova Compared to Lovaza study.

Looks like almost a challenge to lovaza. But why ?