as an investor with hard earned money invested into a company like AMRN, you should know exactly why you are invested right now. Every investor should do research on what exactly an adcomm is. The only thing the FDA panel is voting on is SAFETY and EFFICACY. We already know based on many clinical trials that not only is amarin one of the safest drugs on the market, but it is superior to all of the other triglyceride meds on the market. The panel members will weigh the risk reward scenario for the drug based only on safety and efficacy. In 2012 Novo Nordisk was before the panel with insulin degludec injection. The panel voted 8 yes and 4 no. After reading the transcript it was clear that due to Cardio side effects of the drug that most panel members wanted a caridovascular outcomes study to get a clearer view of the drugs uses/limitations. The reason I bring this up is because investors have been saying forever that FDA panel will delay anchor approval and wait for reduce it. THis is the worst misconception I've ever heard. The panel doesn't have the ability to delay approval, each member simply has a yes or no vote. SO yes, the panel can vote no on recommening the drugs approval but they cannot delay a decision. Remember only safety and efficacy are measured. I would say based on the drug amarin has, that hypothetically this should be the biggest slam dunk in the history of FDA panel reviews. What industry professional would not recommend this drug based on the only two factors they use, SAFETY and EFFICACY.
For god sakes everybody with a brain knows the panel will recommend off this meeting, but the FDA is the final decider in the end. The panel recommendation is only just that---a recommendaton! The agency can follow it, and overrule it either way in the end! And they have done all variations in reviewing past drugs!