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Re: linhdtu post# 8705

Wednesday, 06/19/2013 1:35:31 PM

Wednesday, June 19, 2013 1:35:31 PM

Post# of 426730
There is no negative, will be unanimous vote for approval, simple as that, the red herring of REDUCE I outcome before Anchor results is ridiculous.

There is ZERO requirement for this, they will let doctors decide if it is worthwhile to give before REDUCE IT results.

With no side effects FDA has no reason to step in even with any questions on reducing cardiac events since it may reduce cardiac events(only study ever done says it does and zero studies says it doesn't) as Anchor approval and REDUCE IT results are NOT related.

FDA also knows Lovaza is prescribed heavily in Anchor population and has bad side effects so they not only WILL approve but WANT TO APPROVE Vascepa to avoid the Lovaza off label prescriptions which are not safe.
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