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rosemountbomber

01/11/23 6:38 PM

#397739 RE: Number sleven #397738

Sleven, I believe that is because of the fact that the company realizes that in the US, docs, insurance cos, and patients will because of cost use the generic equivalents. Yes, I know it means more pills but cost consciousness wins out here.

dukesking

01/11/23 7:03 PM

#397748 RE: Number sleven #397738

NS, Yes, I posted yesterday that it was the one thing in the preliminary Q4 report that stood out to me. I haven’t fully grasped the reason or logic behind the decision not to seek FDA guidance and approval for an FDC in the US. I don’t buy that it’s because it won’t sell because doctors can prescribe GV and a generic statin to substitute an AMRN FDC prescription. If they’re developing it for EU and ROW, it shouldn’t cost much to get FDA approval and release it in US too. It doesn’t make sense to me. It’s like not selling Vascepa in the US because doctors and insurers write and cover GV for the CVD indication. It has to be something else at play that KM isn’t divulging. Who cares about doctors and insurers pushing GV and generic statin. The FDC would increase brand awareness, brand loyalty, and increase prescriber and patient use. IMO

ziploc_1

01/11/23 7:25 PM

#397761 RE: Number sleven #397738

Nsleven...It would be too much of a strain on Amarin's present budget to introduce a FDC in the U.S. at this time.

The FDC has to be has to be first cleared with the FDA....If it were to contain MND-2119, that would also need FDA clearance.

In the hands of a BP, a FDC could be introduced in the U.S. as well as in Europe and consist of a statin plus MND-2119 rather than Vascepa.

If not for judge Du, Amarin would,by now, have had the cash to do this themselves.

tke458

01/11/23 7:25 PM

#397762 RE: Number sleven #397738

I did find it interesting and I think it dovetails with efficient allocation of resources (especially when your resources are somewhat limited).

With no generic competition till 2031 at a minimum, all future investment needs to be placed outside US unless something changed regarding the generic situation here.

I also liked his comment surrounding the suppliers and how they know we are the only ones who can expand outside the US. Makes perfect sense.