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Re: finance1229 post# 6925

Thursday, 05/23/2013 7:31:42 AM

Thursday, May 23, 2013 7:31:42 AM

Post# of 426184
Finance


Chab hit the nail on the head. Claims cleaned, the Statin combo is Crestor, 200-500 trigs, up to 5 grams of "Fatty Acids" composed of 90% EPA, and 4 capsule dose.

Not likely to be issued until later this year, fall maybe IMO.

Can't get OB'd until we are approved for Anchor.

For Amarin to seek approval they would need a small dosing "phase 1 study", file sNDA for combo using 505 (b) (2) and run the 10 mo PDUFA cycle. Efficacy and safety data pulled from Marine and Anchor phase 3 studies.

This Combo drug will be sought after and approved late 2014 early 2015. Unless Amarin's waiting for hydroxy-lipitor NCE possibility. IMO, why wait...flood the market with Lipitor/Vascepa and Crestor/Vascepa and let physicians choose the statin.

Yes, combo/Anchor 200-500 has more value to BP, especially if Hydroxy-Lipitor combo can garner NCE status. If Pfizer M&A, they could have this combo on the market late 2014.

Williams
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