Amarin Corp Plc (AMRN)

[HDGabor]

Ajax,

I still do not understand, how any SPA could be revised for an ended study, but never mind. It’s more interesting – if I understand you correctly – that the reason of this debacle was that Amarin does not want to include the Black Box Warning as “no proof of CVE reduction”?

“This would allow the Co to sell Vascepa for Trigs between 199-499mg/dl, but not allowing them to market it other than lowering Trigs. There would be a Boxed warning that Vascepa has not been shown as reducing CVE.”

It’s – for me and for sts66 (if I read it correctly) – full ANCHOR. I do not have any clue they would like to include “CVE reduction”. Everything is in line with the “label” above:
- definition of ANCHOR
- the indication
- they are running R-IT for proof

So, I do not see the rationality to refuse what they claimed. When and what we missed? How did you come to the conclusion that they want R-IT label now.

Sorry, but it is still unbelievable. (Maybe your source misleaded you.)

zumantu & mrmainstreet: Why is the proposed “label” above is a compromise? It is ANCHOR.

mrmainstreet & L0tsaluck2000: “tying approval to Reduce IT” – I guess Ajax mean: (ANCHOR sNDA) approval tying to R-IT (50% enrollment).

mrmainstreet – The first part is still true ? regarding Steelers But you have right, I missed it. The mea culpa addressed to „Dancing in the dark”. (Kiwi: it was the second ? )

Dancing in the dark: Mea culpa: the shelf is active, all of my speculation / idea regarding the delay amendment was a bullshit. (I do not understand why they issued the amendment, but it should be unimportant reason.)