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jessellivermore

09/04/18 12:29 PM

#140464 RE: ziploc_1 #140459

zip...

Sounds good to me...It's all about "Truthful and Non Misleading" information...

I do believe if the R-I trial shows important and significant CVD event reduction in statin patients (MACE HR <.85 with P < .010) with robust SEs...The information will be generally known amongst clinicians and a substantial proportion of the general USA population...The notoriety of "Fish Oil" should elevate this to the status of "common knowledge"...

IMO this is going to greatly facilitate whatever Amarin plans to do regarding marketing...Ie IMO the drug will sell itself...devoid of an army of reps or a saturation of TV ads...

Who doesn't want to cut their risk of having an MI down?

":>) JL
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oneragman

09/04/18 12:42 PM

#140469 RE: ziploc_1 #140459

zip, I would just add that if they don't agree, I believe the same judge held jurisdiction to resolve/rule on any disagreements. Assuming a successful RI readout, AMRN wanted to commence DTC advertising immediately and they could not agree with the FDA, would the judge rule that AMRN has to file a new case or would he simply look at the facts and rule? AMRN has a SPA with the FDA that they successfully fulfilled with a successful outcomes trial. AMRN wants to promote that successful trial. Does the agreement specifically exclude DTC? I don't recall but I don't think so. My hope/expectation is that AMRN and the FDA already have worked out an amicable agreement.
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Whalatane

09/04/18 1:11 PM

#140476 RE: ziploc_1 #140459

Zip. If R-IT shows 15% RRR with a P value of .01 and key secondaries doing even better ....it will be huge news on any site read by Cardiologists ......especially when followed up by details in the NEJM .

Those Cardiologists I know ( 4 ) will almost certainly begin prescribing , it since its already an approved drug with an excellent safety profile.
In my experience , watching what happens at my wife's Renal dept ...once the Head of the Dept gives the OK ...everyone authorized to prescribe under him / her ...starts prescribing .

JMO
Kiwi