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Re: None

Tuesday, 07/28/2015 3:48:05 PM

Tuesday, July 28, 2015 3:48:05 PM

Post# of 428987
Even though several new posters on this site are shocked the FDA used a trick question at the 2013 AdCom, involving the ANCHOR Trial to obtain the negative vote they desired so badly, but this was nowhere near the worst thing they did. They rescinded the SPA based on so called "new science" (paragraph 76) which emanated from studies which were not new, ACCORD results were published before the amended SPA, was signed. Also the "new science" used drugs that were in no way related to EPA without any scientific justification to the FDA's allegations that EPA would behave exactly like niacin or fenofibrates.

IMO the company should have continued the FDA SPA appeals process..Or if possible they should continue. I am amazed this material on the AdCom and SPA are turning up in these transcripts, but do not see how the judge can act on them..

":>) JL
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