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ziploc_1

Re: HDGabor post# 35913

Sunday, 10/05/2014 2:59:12 PM

Sunday, October 05, 2014 2:59:12 PM

Post# of 426828
We are splitting hairs here. The SPA contract for Anchor was predicated on Vascepa efficacy in lowering triglycerides on patients taking statins. Neither the FDA, itself, nor the SPA contract specified that it was necessary to finish an event study before Anchor approval could be conferred. It was only at a later time, much after the SPA, that the FDA changed its mind and decided to abrogate the SPA for inadequate and non-compelling reasons.
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. The, after Amarin spends a fortune on the house, The FDA says; "I want to withdraw from our contract because I don't like the color of the house.
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