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exwannabe

09/12/14 6:59 PM

#34229 RE: biowreck #34223

Fast track status sounds plausible, amarin management should investigate this option.


But even if they get such (unclear given the FDA SPA position), what does it gain AMRN?

Some extra meetings with the FDA? Hell they already are having such almost daily.

A rolling submission? Meaningless when already a commercial product (only the clinical section matters any more).

A priority review? OK that would save a few months post R-IT.

So this really matters for virtually nothing.