Replies to post #190424 on Amarin Corp Plc (AMRN)

[Whalatane]

If you use this definition

General: Bargaining (give and take) process between two or more parties (each with its own aims, needs, and viewpoints) seeking to discover a common ground and reach an agreement to settle a matter of mutual concern or resolve a conflict.

Then yes Thero thinks he's negotiating. But if he doesn't like the outcome of these negotiations ..say FDA won't agree to TG's of 100 on the label ...he can't walk away .

If no agreement is reached , no conflict resolved .....Thero will accept what the FDA decides.

Kiwi

[jfmcrr]

Are they negotiations or not?

If you mean that the final decision is FDA's, then of course that is true.

I would like the above question answered.

Yup, they are. Now a question for you. Do you negotiate scheduling access to the tennis courts, a plea deal for reducing Murder 2 to Manslaughter, or buying house in a red hot market with the same strategy?

You could make the case that an opening position could be "To prevent CVD where such risk may exist." That works for me. But the risk is an eye roll and "We'll take your request and your application under advisement." The guy on the other side of the table sees himself as a guardian of the public good and gateway against unacceptable risk. If you can get what you want and leave the counter party feeling that they got what they want, you're gold. The basis of negotiations is Reduce It and how to apply the findings.

[VuBru]

Raf - FWIW - My guess is that they will request the TG level reflected in the original R-It protocol (TG = 150+). I think they will do this to play it safe, minimize possible negative discussion at an ad com (which might raise other issues they don't want to raise), and speed the process along. The NEJM paper indicates that they had a 150 TG cutoff initially, but per protocol allowed down to 135 to address daily fluctuations. This procedure was later dropped and the entry criterion was raised to a firm TG = 200. Only 10% of the sample had TG levels <150, and I am not sure whether statistically (at an ad com discussion) that would be viewed as enough patients to reliably determine whether V reduces MACE in this group the same as it does in high TG patients. I think there would be less pushback on the TG = 150, since that was explicitly the original entry criterion. Happy to be proven wrong, but that is my best guess.