Replies to post #196343 on Amarin Corp Plc (AMRN)

[IgnoranceIsBliss]

These aren't fully "musts" sts66, they are targets or intentions.

There are examples of late ACs, where the FDA then pushed off the PDUFA data.

But the FDA doesn't need an AdCom here. The other one basically asked the question, "Given what we've learned recently about mere trig lowering, should Vascepa be approved without an outcomes trial." The answer was no.

Well, we have the outcomes trial. It crushed it. According to the FDA's own guidelines, there doesn't appear to be any need for an AdCom:

An Advisory Committee meeting may be held for one or more of the following reasons. Note that this is not an exhaustive list.
1. The application is an NME.
2. The clinical trial design used novel clinical or surrogate endpoints.
3. There are significant issues regarding safety and/or effectiveness of the drug or biologic.
4. The application raises significant public health questions regarding the role of the drug or biologic in the treatment or prevention of a disease.

None of these genuinely apply, unless you think the FDA is going to confer with the National Home Remodelers Association on any safety or efficacy issues they've conjured up.