Replies to post #208782 on Amarin Corp Plc (AMRN)

[rafunrafun]

Kiwi -

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

AVII disagrees:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147834212

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146697269

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146725876


And a bonus re- hsCRP / LDL-c:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144813076

In this trial, LDL-c for placebo increased 7% and hsCRP for placebo increased over 60%

[jfmcrr]

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 .

Nope. But that is why off label exists.

[VuBru]

Can you justify a primary prevention label for non diabetics based on the R-IT data

Not based on R-It data, but would provide a strong reason for an adcom if it was sought.

[sts66]

Does the label for statins mention use for primary prevention, or are they prescribed off-label for that? For many years I believed there was zero evidence statins could prevent the first event, were only useful for secondary prevention, but within the last year somebody posted one study that showed efficacy for PP - don't recall what the study was or what statin(s) were evaluated, or if it was a meta-analysis - all I remember is thinking "oops, I've been wrong about statins this whole time". Do you recall that post/thread?