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jfmcrr

02/24/17 10:01 PM

#101113 RE: HDGabor #101110

Immediately means Immediately ...

a.) it was said as "could be"

It is possible,

This won't happen immediately ...

I am "sure" that the Co will wait with sales / staffing / heavy promotion till FDA decides




I get it. Amarin will be absolutely positively prolly cash flow positive sooner rather than later.

As soon as expenses drop below revenues. Whenever that is.

Got it.

No argument on substance. But cash flow, operations,revenues, and expenses have inertia.

Joe
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zumantu

02/25/17 6:52 AM

#101122 RE: HDGabor #101110

HD, upon publication positive R-I results, the focus will be focused on clinical thought leaders in heart disease. It won't take much to move the flywheel towards administering Vascepa as an add-on

There are already labs that measure EPA levels (Boston heart)
And that testing will immediately increase.

The FDA is NOT a factor for R-I as it was with Anchor. Huge difference between approving a bio-marker versus factual outcomes study. In fact, as we've already seen I predict , insurance carriers will approve coverage ahead of FDA simply because the data will prove they're profits will skyrocket when insured diabetic CVD patients are on Vascepa





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sts66

02/26/17 1:32 PM

#101206 RE: HDGabor #101110

international distribution is a revenue, isn't a cost

Eventually, yes - but first they have to go to the expense of getting ROW approvals for V - hopefully by signing up partners like Eddingham that will pick up all costs plus provide some upfront money. I own several other bios that "went it alone" in gaining or trying to gain drug approvals from the EMA, Canada, and Mexico. EMA process can take several years, it's quite different that FDA process, which I'm sure you know, but others may not.

As far as any continuation studies after R-IT is halted, I could see value in following patients for years, but don't know if AMRN would be willing to continue to supply V for free plus pay for checkups, i.e. continue as an open label trial for some amount of time - I can see arguments for and against that. Also, we've seen some recent articles on follow-up studies done many years after the original trial ended (the niacin raised CV risk for women by 30% one?) - but I don't know if drug companies pay for that research or if universities and/or NIH provide funding for that type of thing, probably varies, a mix of both. If not funded by AMRN, there's no guarantee that anybody would be willing or want to do that sort of long term follow-up study, but if R-IT is a smashing success I'd guess it would generate plenty of interest in doing it, would provide a variety of thesis ideas for those seeking PhD's.