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Re: drrc1949 post# 28636

Tuesday, 06/03/2014 1:51:52 PM

Tuesday, June 03, 2014 1:51:52 PM

Post# of 426566
You have right.

For everybody who is still saying that AMRN indicated CVE reduction:

Please, do not it as attack, but if you do not understand it, you have to blind or has dyslexia:

Since John King misunderstood the indication, he 'challenged' its wording:
‘On February 21, 2013, the applicant, Amarin Pharma Inc., submitted an efficacy supplement seeking to substantially expand the treatment population of AMR101 to include patients with mixed dyslipidemia who are at high risk for coronary heart disease and who are already being treated with HMG-CoA reductase inhibitors (statins).’ (BD by FDA)

Bruno said (something like this): ‘it’s not unusual to include the TARGET POPULATION in the indication’

and as I wrote the FDA said: ‘Although the indication strictly speaks to reduction in lipoprotein levels and improvement in numbers, this indication for this population certainly implies that one should expect cardiovascular benefit from treatment.’ by FDA / Mary Roberts, Oct 16 AdCom
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