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rafunrafun

08/09/19 4:34 PM

#207429 RE: SocialBoom #207360

SB - I disagree on literally every issue you mentioned.

I'll also say I think FDA is 100% correct to hold the Adcom because nobody can answer one question.

How does Vascepa work?


How it works is irrelevant, as long as it works.


Imagine FDA 20 years from now it it were to be determined taking Vascepa for 20 years causes you to grow fins?

And having this AdCom will not address anything pertaining to fins (yes I know that you were being facetious but my answer stands)


I think they love the safety profile. I think they love the Reduce It results. I think they look a Jelis as conformation Mineral Oil is meaningless.


Jelis literally has nothing to do with MO. No one will argue that EPA doesn't work, the worst they can say is how much effect MO had. 0% IMO.


But still they can't answer that basic question. So for cover they will get the panel to vote on has Vascepa shown to be effective delivering benefit with a very safe profile?

Oh your love for government bureaucracy -- what will that accomplish, besides needless deaths by the delay.


They will get the YES and have the cover they need and we will be off to the races.

just pathetic.