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Re: None

Thursday, 10/24/2013 10:11:42 AM

Thursday, October 24, 2013 10:11:42 AM

Post# of 424836
I have just one question here that I can't seem to get past with regards to AMRN and the Anchor sNDA. Specifically, while there is no evidence at the present time acceptable to the FDA that lowering TGs will have a beneficial effect on CVD there is also no proof that lowering TGs will not have a beneficial effect. In such a situation, isn't it the safer move here to approve the indication (even if only conditionally) rather than reject it outright especially in this case where there are no discernible health risks from taking Vascepa?

I agree with the point made earlier that FDA really doesn't care if its sued and how much is spent defending a suit. They can just tax us some more. On the other hand, wouldn't the FDA seek to avoid really bad press which would be assured if ReduceIt comes out in three years with blockbuster results? No one (even government bureaucrats) wants blood on their hands.
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