Replies to post #91014 on Amarin Corp Plc (AMRN)

[HDGabor]

sts-

Appears you are saying AMRN responds to ANCHOR CRL with R-IT data

No I am saying: AMRN responds to sNDA 005 CRL with R-IT data (as was "suggested" by the FDA).

R-IT supersedes ANCHOR, it's a much broader indication with a different label

Different, but not a totally different.
- ANCHOR "INDICATIONS AND USAGE" was " Co-administration Therapy with Statins for the Treatment of Mixed Dyslipidemia VASCEPA® (icosapent ethyl) is indicated as an adjunct to diet and in combination with a statin to reduce TG, non-HDL-C, Apo-B, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent." with the "Limitations of Use: •The effect of VASCEPA on cardiovascular mortality and morbidity in patients with mixed dyslipidemia and CHD or a CHD risk equivalent has not been determined."
- R-IT "INDICATIONS AND USAGE" could be the same as ANCHOR above (or modified a little bit to include patients w TG 150-200) without the "Limitations of Use"

Much broader as includes patients w TG 150-200, but the real difference is the lack of LoU.

The CFR itself allow it (and the CRL "suggest").

That's what nearly everyone here has been claiming and believing for a long time (except BB), including yourself IIRC - that is ANCHOR dead

- Yes, ANCHOR is dead (I did not say differently)
- ANCHOR indication (with LoU) isn't equal with sNDA 005. It was in the original form, but it does not have to forever... Amarin could resubmit sNDA 005, with the new data (see CFR, efficacy supplement) and FDA could classifies as Class 1 / 2-month review (worst case: they will classify as a new, full review cycle)

Best,
G