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Re: HDGabor post# 115449

Wednesday, 10/04/2017 6:05:28 AM

Wednesday, October 04, 2017 6:05:28 AM

Post# of 426453
HDG:......"FDA did the right thing with ANCHOR already."

IMO they did the WRONG thing with Anchor on many levels:
1. Marine and Anchor had proven Vascepa to be safe
2. They had signed a SPA which dealt only with lowering trigs, not lowering events.
3. Anchor showed that Vascepa lowered triglycerides, which is a good thing,not a bad thing
4. They used unrelated studies as the basis for changing their minds on the SPA
5. They demanded an events study even before they would consider Anchor for approval......contrary to the SPA
6. They conducted an Adcom, in which they had already decided it should result in rejection of Anchor
7. They conducted the Adcom, not as a neutral party, but as an adversary of Vascepa
8. They framed the questions for the Adcom in order to get the result they had already decided on.
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