Amarin Corp Plc (AMRN)

[concapk]

Occum's Razor = simplest truth

Why Adcom ????

trigs on top of statins = reduce-it study protocol ( yr 2013) lowers cardiovascular events...

trigs on top of statins + MOA ( METHOS OF ACTIONS )= REDUCE-IT STUDY RESULTS ON 09-24-2019

The PRIORITY REVIEW would have given us a label for lowering trigs 135/150 -500 on top of statins to reduce cardiovascular events ( per SPA ) .... but doesn't explain the final RRR in REDUCE-IT STUDY... LABEL would state ( lower's trig's and COULD lower cardiovascular events ).....

The EVAPORATE TRIAL studies the MOA which is reduction of systematic inflation which accounts for the RRR of the REDUCE-IT STUDY....

The ADCOM will concentrate on the MOA ( METHOD OF ACTION )... THE COMMITTEE will ask multitude of questions concerning VASCEPA'S results... which effects label...

The final vote could be whether they give AMARIN label for original SPA and then require AMARIN to submit a new SDNA with EVAPORATE'S results OR wait until EVAPORATE'S RESULTS come in to give the new expanded label.... FINAL QUESTION ( SHOULD WE WAIT UNTIL THE MOA IS ESTABLISHED OR GIVE AMARIN A RESTRICTED LABEL )

The FDA will work this to their benefit and it will be on JT and AMARIN to get some kind of label at the ADCOM... The FDA will protect the STATIN industry for as long as possible.....