"I would note that Amarin is already approved for sale in the US.  US doctors can easily prescribe it for off label use...which may explain why the FDA may have dragged its feet a bit on AMRN.  But I want to repeat that I don't know what the Amarin situation is all about re FDA approval for further indications."

I strongly suggest that everyone familiarize yourselves with the FDA review process if you are going to continue down the road of discuing FDA and drug approval. I'm no expert, but from my following of Esperion, Amarin and The Medicines Company (all pretty much single drug companies) I have learned a ton. Check out their websites for investor news about NDA/MAA filings and the timelines and steps they have encountered. Even though Amarin's is a supplemental NDA, same timeline/process applies.

Here's a link to the FDA that describes the process. Cliff notes version: Once NDA is submitted, the FDA has ~74 days to review the application and let the applicant know that it is complete and accepted. At this point, the application can go down a standard review track (an additional 10 months) or priority review track (an additional 6 months). And sometimes the review process involves an FDA Advisory Committee (AdCom) that may lengthen the timeline. The date of the final FDA decision is the PDUFA date.

Amarin was on track for priority review track with FDA decision/PDUFA date expected end of September, but FDA decided late in the game to schedule a November AdCom and the PDUFA got pushed to December.

Esperion finished their LDL-C lowering Phase 3 programs last year, submitted NDA/MAA in February 2019 and expect approval around Feb 2020.

The Medicines Company is just wrapping up their LDL-C lowering Phase 3 programs and will likely submit NDA/MAA end of this year or early next year with approval end of 2020 at the earliest.

BDAZ