Replies to post #90795 on Amarin Corp Plc (AMRN)

[HDGabor]

raf- (&me)

using RI trial data to apply for ANCHOR approval

When did I say: "to apply for ANCHOR approval"? I said: resubmit sNDA 005 (that will be a modified version) to apply for Class 1 and get R-IT indication.

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me-

But the company will be able to resubmit only if RI data becomes available which requires interim stop.

Of course R-IT should be stopped for any data submission ... I thought it is obvious ... does not have to mention ...

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Best,
G

[Biobillionair]

That is what the FDA asked for in CRL.
BB

[rafunrafun]

I figured that because it was a CRL for anchor indication, they could submit RI data to seek ANCHOR approval