Amarin Corp Plc (AMRN)

[Whalatane]

VuBru. re this statement of yours

Agreed that secondary prevention is a no brainer.
If Amarin had applied in their sNDA for that label alone, and had sent in a separate application asking for a primary prevention label, we would have secondary prevention label approved in September without doubt.
Probably would have an adcom for the primary prevention issues regardless.

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Completely agree .

Some here may not completely understand what primary prevention is ..( prevent / delay onset...known risk factors ) as Statins are prescribed for primary as well as secondary prevention ...( secondary being evidence of existing disease ) .

Can you justify a primary prevention label for non diabetics based on the R-IT data ?
I can't see the FDA going that far .
JMO
Kiwi