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investorfreak69

09/21/14 10:50 AM

#34926 RE: me33 #34925

FDA = Scum & Corruption

HDGabor

09/21/14 10:56 AM

#34927 RE: me33 #34925

"So in your opinion the Anchor trial data on label is unlikely until Reduce-It?"

No, 2.) and 3.) could contains ANCHOR data and I could imagine that they could submit a new sNDA about it in case of 1.).

I do not think FDA hates Amarin:

NCE: They always applied the active moiety approach. The new element was, how they determined the active moiety. I am still believe - based on earlier cases sponsor vs FDA and sponsor vs USPTO - the court will overturn it as the statue is about active ingredient.

No ANCHOR as it is currently, but data on the label and modified indication is still possible. However, to go further with "ANCHOR" the appeal process should be finished.