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Biobillionair

11/17/19 9:36 AM

#227431 RE: jessellivermore #227424

JL-A wide label is a must for Amarin to grow. First Amendment is a complete joke when it comes to improving script growth.

IMO you are 100% correct.

A narrow label limits peak sales to under $5B and this is with the best launch execution ever. A wide label leads to >$10B even if it’s the worse marketing campaign in the 21st century. Good execution on marketing a wide label and Vascepa has peal sales of $15B starting 2022 (next AHA guideline full update).

A great execution of a global launch and Amarin could buy PFE in 2025.

BB
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sharinky

11/17/19 9:46 AM

#227433 RE: jessellivermore #227424

I worked in Healthcare Finance and am well versed in how the insurance industry operates. I am not saying that the label could not limit access as it could.

Vascepa is Tier 4 currently for CVS Silver scripts whether you are on label or not. The Tier for a Medicare Part D plan will not change until CMS changes how it treats this drug. It is a separate government agency from the FDA. Coverage for it and it will move to a different Tier at some time in the future. It will not be in two different tiers as you suggest. We are going to need lobbyist to get the changes made for the Part D plans, that is why the AHA is working on it. Just the change in indication from the FDA is not going to help with the Medicare plans.

I personally have gone through 3 insurance changes while taking Vascepa so I understand personally and professionally.
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concapk

11/17/19 11:19 AM

#227466 RE: jessellivermore #227424

JL,

ADCOM revealed that the panel did nod read the DOC'S or do any DD on VASCEPA .... They completely failed to ask AMARIN about the MOA throughout the proceedings...this board is so far ahead of the medical community...

JT is playing CHESS with the FDA..... He is proceeding with four steps to accomplish his goal.... STEP 1 just get the indication approved at ADCOM ...brought the right people to deal with briefing DOC'S ... 16-0 favorable result.... STEP 2 set up late breaking EVAPORATE TRIAL results at AHA conference establishing MOA... high trig's biomarker with lowering systematic inflation as method of action producing outstanding REDUCE-IT results..... STEP 3 work on labeling for PRIMARY/SECONDARY before PDUFA date of DEC.28..... probably a week before CHRISTMAS, so that FDA employees can go on vacation knowing they did something positive for the AMERICAN public..... the SAFETY profile allows FDA to cross all boundaries for this indication.... STEP 4 settle the generic lawsuit before end of 2019 keeping the PATENTS impenetrable ......

Complete the 4 STEPS and start selling VASCEPA to the masses ( volume over price )....

CHESS ( thinking-plan of action ) versus CHECKERS ( one move at a time )