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Re: Ajax133 post# 17965

Friday, 10/18/2013 3:20:05 PM

Friday, October 18, 2013 3:20:05 PM

Post# of 426697
I'm not sure why this is news, I posted ahead of time why BP would be for AMRN getting approval because otherwise this means all trig lowering drugs in the future must have long term expensive outcome studies. That's what the FDA has to say to deny AMRN approval for Anchor.

The FDA may very well say that for all indications, marine included because they rationalized the marine approval due to pancreatitis not CHD or trig lowering. So AZN will not get approval for their new purchase at any level unless outcome study, same for all these others.

If the FDA approves any other drug without an outcome trial they are legally going to lose any lawsuit AMRN brings. They won't do it, they need to approve AMRN in December(unlikely) or require outcome studies for any trig lowering drug. Plain as day to me, was the biggest reason I believed BP was for AMRN getting approval.

A few days later, sold out yesterday morning but still appalled at FDA's action here, they all but said we don't care what any established medical society says, trig lowering is not proven to help CHD. Sorry anyone that thinks differently. That approach is based on poor science and poor analysis of studies conducted. ignoring all evidence to the contrary.

They don;t state...maybe there is no benefit, they state there IS no benefit. Ridiculous.
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