Replies to post #58035 on Amarin Corp Plc (AMRN)

[zumantu]

JL, well said... What can the FDA give to enable the suit dismissed? That is the question that we need to answer. IMO your scenario was exactly what the Judge had "teed up".

He was saying "FDA, go get your house in order, or your authority is about to be curtailed for reckless behavior

Some Aussies here think what they give is not appeal... Meh I don't see that as a big deal

Amarin is already running wild with Anchor and Jelis data - no putting that Genie back in the bottle - even if appealed

[BioChica]

I like where you are going with this idea. Hope you are right about the label change - seems to be out of bounds regarding their policies and procedures. Seems they would have to void the CRL and approve Anchor sNDA with modified label. The higher ups would have to agree. The Anchor SPA, well they could just sweep under the rug!

This kind of compromise might take awhile! In the mean time sales and marketing can have it's day. I can imagine moral is high!

Amarins lawyers do have the FDA in an arm lock!

[sts66]

The only thing the FDA has to offer is a label change. If you have another suggestion, I'm all ears.

How about not requiring AMRN to get FDA approval for an future off-label promotional statements? Although I can't see how the FDA would agree to that, they would lose all control over AMRN - untenable position for them IMO. This is the only thing I can think of that's a real reason for the delay - talks of looking at R-IT data, getting ANCHOR label, SPA reinstated, etc., are all off base IMO.

[HDGabor]

JL-

You are much better than me regarding science: What is the "New Science", proves TG reduction decreases CVE?

I see two possibilities:
a.) more detailed communication and /or the case won't go further, technically the Preliminary I will became Permanent I, meanwhile legally not (I am not 100% sure, this is possible)
b.) set-up a second (blinded to the sponsor, earlier: ie.: @50%) interim look by the DMC

Best,
G