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Re: linhdtu post# 8725

Wednesday, 06/19/2013 3:59:56 PM

Wednesday, June 19, 2013 3:59:56 PM

Post# of 426735
"If Reduce It can't be finished then somebody else with more secure funding can do the same thing later."

I think that's not going to happen, they dosed in 2011 so by Anchor they are 2 years in of a 6 year study and nobody else is remotely close to doing a study.

Having Reduce IT underway was a clear indication that the FDA wants this question put to bed. Many cardiologists and doctors want Reduce IT. AMRN cannot afford to do Reduce It without Anchor and FDA knows that.

The comparison to NCE is misplaced. FDA has been sued for NCE decisions, FDA has had to reverse previous decisions, FDA has created a whole new panel and guidelines for NCE thus NCE is a totally different ball of wax when compared to Reduce IT and Anchor.

The FDA would need to totally, 100% reverse course on Anchor and there is no compelling evidence to do so. Vascepa does what it says it will do with no side effects.

The only argument people make against it is that the FDA would want outcome trial results before approving. Dismissing that is easy when you analyze it and realize they won't get the outcome trial without approval. To say someone else will do it is not reality. That would be way down the line and does the public zero good.
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