Saturday, December 05, 2020 2:31:49 PM
Does Amarin have a moral/ethical/etc responsibility to oust Generics ASAP if they believe that gV is inferior to V or God forbid, harmful to patients?
I understand that the business and technical answers are NO. But if these imposters are riding Vascepa's / RI's coattails, misleading people into believing that gV reduces CVD, when (if) Amarin believes this is false, at what point must they blow the whistle, if the FDA are taking their sweet time?
I believe that the smell difference is the game changer for us - regardless of FDA bioequivalency standard, the two products aren't the same. Generics just knew how to game the system, similarly to what my high school music teacher told me, which I'll never forget. He said:
Since I already got accepted to college and in despised music, I knew exactly which projects I can get away not doing and still pass the class (I just needed to pass). I played by the rules and gamed the system.
IMO this is what Hikma did with their pill. They complied with the bioequivalency standard but took advantage of the lack of the oxidation protocol, hence the stink.
If the keyboard to V's efficacy is the (lack of) oxidation and gV is oxidized and using V / RI to mislead people, then regardless of business/shareholders duty, Amarin has a moral duty to inform the American people of this fraud. Yes, I called it fraud.
All IMO.
I understand that the business and technical answers are NO. But if these imposters are riding Vascepa's / RI's coattails, misleading people into believing that gV reduces CVD, when (if) Amarin believes this is false, at what point must they blow the whistle, if the FDA are taking their sweet time?
I believe that the smell difference is the game changer for us - regardless of FDA bioequivalency standard, the two products aren't the same. Generics just knew how to game the system, similarly to what my high school music teacher told me, which I'll never forget. He said:
In my 20+ years of teaching, I've never had a student do less work but pass my class, congratulations.
Since I already got accepted to college and in despised music, I knew exactly which projects I can get away not doing and still pass the class (I just needed to pass). I played by the rules and gamed the system.
IMO this is what Hikma did with their pill. They complied with the bioequivalency standard but took advantage of the lack of the oxidation protocol, hence the stink.
If the keyboard to V's efficacy is the (lack of) oxidation and gV is oxidized and using V / RI to mislead people, then regardless of business/shareholders duty, Amarin has a moral duty to inform the American people of this fraud. Yes, I called it fraud.
All IMO.
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