Ralphey, That FDA decision, not to approve ANCHOR, was because of a change in opinion. At the time other triglyceride lowering drugs were putting out failed outcome studies. The reason those drugs were originally approved was the FDA opinion that they might reduce CVD. I don't know what current FDA thought on the issue is. A large portion of the GSK argument was based around the idea that the label carve out was a failure. It failed because post MI-LVD could not be cleanly be separated from CHF. The two indications we're intertwined. I think that argument could work for SHTG and CVD.
Just my opinion.
Sleven,
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