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Re: ziploc_1 post# 35915

Sunday, 10/05/2014 3:28:55 PM

Sunday, October 05, 2014 3:28:55 PM

Post# of 426182
The SPA contract for Anchor was predicated on Vascepa efficacy in lowering triglycerides on patients taking statins with the assumption that it will further reduce CVE. SPA isn't about approval, it's about the study and (in this case) the condition to submit the sNDA.

Its somewhat like the prospective buyer (the FDA) telling a prospective seller(Amarin); "I will buy your house on the condition that the seller puts a mountain of money into it to fix it up and assume that all necessary permission will be granted. Then, after Amarin spends a fortune on the house, The FDA says; "I want the necessary permission before I buy, because regulation was changed and I did not get the permission in case of other seller/ house."
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