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KCSVEN

10/13/13 9:21 AM

#16677 RE: louieblouie #16672

The FDA always has the right to adjust things based on new science. I would imagine the 75 day papers AMRN received had this in it. So I imagine AMRN was aware of this for several months and have been preparing.

The FAQ answer and the analyst notes lead me to believe AMRN was not surprised by the REDUCE IT question but that begs the question why the FAQ that states the FDA has not advised us that we need to finish REDUCE IT for approval is there if they got 75 day papers suggesting it would be a question. So it's a little up in the air when AMRN knew but my guess is 75 days out.

I think AMRN was well aware of the issues and may have only been surprised at the questions about the placebo and the attack on the data more than the Reduce IT part.