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Alias Born 07/26/2013

Re: Biobillionair post# 11272

Friday, 07/26/2013 10:49:37 AM

Friday, July 26, 2013 10:49:37 AM

Post# of 430335
BioBillionair;

From your post "The FDA appears to have ruled Vascepa is NOT novel, despite USP considering Lovaza as a mix of seven Omega 3's, separate CAS numbers, and numerous PubChem references."


Originally you were suggesting the CDER Performance report to Congress indicated that Vascepa was not an NME (3 year exclusivity). You concluded it thus was awarded an NCE (5 years exclusivity)designation.

Now, per your comment above, you suggest the FDA has ruled Vascepa is an NME with only 3 year exclusivity. What is the source of information for your latest interpretation.

C
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