Amarin Corp Plc (AMRN)

[jessellivermore]

raf...

I agree and have predicted no AdCom...IMO..FDA does not want the previous AdCom brought up...as FDA played fast and loose with the rules...Not because of anything Amarin did...but because FDA made a huge mistake in offering the ANCHOR SPA without requiring Amarin to do an outcomes trial.

They had to close ranks on Amarin and withold the label expansion..FDA now has the outcomes trial results...and R-I results are such that they answer all questions...Mary Park's famous question in 2013 was...(Paraphrasing).."Considering the ANCHOR Trial...how confident do you feel that Vascepa will lower CVD event risk?"....The answer had to be...I don't feel very confident"...because all ANCHOR showed was Vascepa would lower trigs....and not raise LDL-C...But there was no proof V would reduce CVD events because ANCHOR only measured trigs and other blood levels...but it did not measure V's effect on reducing CVD events..

REDUCE-IT was the outcomes trial that sanctified Vascepa...All of us including FDA (well maybe there is a guy out there that doesn't understand the R-I trial results)...But believe me the FDA does...

Thank you Amarin, Dr. Bhatt, Dr. Miller and all the patients in RI..and the doctors that monitored them...They have helped us financially and more importantly saved a lot of lives...

":>) JL