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rosemountbomber

04/26/20 10:17 AM

#269269 RE: dukesking #269268

And of course Amarin waited forever to submit their application for European approval. Playing role of tortoise I guess.

But there is a bright side. Again we hear that V will sell itself so Amarin can save money on reps and DTC ads. And, if the appeals verdict goes the wrong way we can sell a ton of V as a generic at lower than generic prices.

JB_Biotech

04/26/20 10:26 AM

#269271 RE: dukesking #269268

Unlikely. Generics can compete with Vascepa because physicians can substitute Vascepa prescriptions gor identical generic products. Generic vascepa would be proven to lower CV Risk (Reduce-It label) although generics cannot promote it’s CV lowering effects. I highly doubt than an unproven EPA Would be substituted for Vascepa/generic Vascepa in CV prescriptions. Too much risk for physicians, if proven generics exist

couldbebetter

04/26/20 10:34 AM

#269272 RE: dukesking #269268

dukesking, That is the NIGHTMARE scenario...However, the DREAM scenario
is that a BP such as Novartis or Roche, that have excellent ties with
the EMA and the European medical establishment, would acquire AMRN,
then promote and distribute Vascepa in a massive fashion and
essentially cut out all of the competition. Europe BP may have
political and economic clout to make certain things happen to
insure that Vascepa is a big winner, "IF" it is under "their"
control. (If JT attempts to GIA there he will be dog meat!)

dukesking

04/26/20 10:46 AM

#269277 RE: dukesking #269268

Thanks for the replies. KDPharma is going for an indication for a very serious and untreatable disease( FAP).If they don’t have success with their phase 3 trial, it will end that threat for now. I hope and believe the FDA will deny their request to treat for Covid without substantiating proof of effectiveness. All IMO.

circuitcity

04/26/20 10:54 AM

#269279 RE: dukesking #269268

Oh, this is just great, after we lost US and think EU is in pocket anyway, but somebody is trying to get in the pocket actually!

Whalatane

04/26/20 11:14 AM

#269282 RE: dukesking #269268

Duke. Exclusivity My understanding is that AMRN has 10-13 yrs (?) exclusivity for the Reduce it indication in the EU

We should chk / ask AMRN if that prevents off label scripts of Epaspire ( if approved in the EU ) for use in the R-It indication

Exclusivity puts into place a period of time during which no other applications can be accepted and/or approved for the same active ingredient. This means that other manufacturers that may wish to develop alternative formulations or generic versions of the drug will not be able to have their products approved during the exclusivity period.




Kiwi