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stangish

04/24/13 4:08 PM

#4985 RE: funnygi2 #4984

Completely false. I have talked about this a lot on ymb. They are not contingent upon one another and do not go hand and hand. As I mentioned on ymb (many folks piled on me for saying it) but I know for a fact that Omthera also has to run an outcome study for the SAME indication as Amarin. We all know they have zero chance of getting NCE.
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Ajax133

04/24/13 4:51 PM

#4988 RE: funnygi2 #4984

There is an FDA loop hole called " Presumption of Favorability " under which all the various Insulin Drugs, all The Low Molecular
heparin drugs, and various Amino Acids have received NCE's It was
recently used on a Novo Nordisk new version of Insulin. It's a bit harsh to refer to it as a loop hole, but I can't think of another term.