Replies to post #223925 on Amarin Corp Plc (AMRN)

[Mr1979]

JL

So you think it will just be one question they’re voting on and then the FDA will apply a label based on the vote and the discussion that happens at Adcom?

[Atom0aks]

raf....

Regarding many questions...Actually the FDA likes to use one question...The panel question...That was the case in 2013...The AdCom panel was charged with only one question...

Paraphrasing the question was.. considering the Marine and Anchor trial results how confident do you feel Vascepa will lower CVD event risk..The answer was obvious since neither MARINE or ANCHOR addressed the issue of CVD event risk..(please understand I know this is not the exact wording of the Mary Parks question)...Both MARINE and ANCHOR were surrogate (blood level trials and were not CVOTs...

R-I is a CVOT...a cardio vascular outcomes trial....It would be very nice if the FDA asked," Considering the R-I trial how confident do you feel Vascepa 4gms/ will lower CVD event risk....The panel question is usually posted 48 hours before the AdCom....

":>) JL

I agree, that while many topics will be discussed during the meeting, the committee will be asked to vote on one question. I am predicting that the final question will be something similar to this,

"Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described cardiovascular outcomes are sufficient to grant approval for co-administration with statin therapy for primary prevention?
Please provide the rationale underlying your recommendation."

I think this is where the research is weakest, and I would not be surprised if the question is even more narrow to specifically address "patients had diabetes mellitus and at least one additional risk factor" as described in REDUCE-IT.

[NickHous]

JL, if that is the panel question, why don't they just post the answer 48 hours before adcom! Lol! A resounding YES! I'm leaning towards adcom is all about the label.

[HDGabor]

JL-

Actually the FDA likes to use one question...The panel question...That was the case in 2013...The AdCom panel was charged with only one question...

I won't be surprised by (expect) more than one question during this AdCom. … but it won't be a problem.

Best,
G