Amarin Corp Plc (AMRN)

[Mellowmood77]

I agree the word choice is poor and it’s certainly possible I misunderstood it, which is why I emailed Elisabeth for clarification.

HOWEVER, let’s not forget Repatha which was approved for stand-alone treatment even though the trial was not powered to support this! 100% of the patients in that trial were on statins.

So why approve REPATHA for stand-alone treatment with no data to prove it? Probably because it acts on LDL, the gold standard for getting drugs approved for CV risk reduction, and not trigs.

Now if you can prove or profoundly support (at the adcom) that VASCEPA lowers CV risk because of MAs unrelated to trig lowering (which in previous studies did not show CV risk reduction), I see no reason why Vascepa couldn’t get a stand-alone indication like Repatha did.

This would be an excellent reason to hold an ADCOM (to go over Vascepa’s MA) and a vast label would make sense of other things such as:

-JT being almost 100% sure an ADCOM
-JT stating in 8/8 call “a drug to treat 70 million people”
-Delay in Adcom announcement since the data is vast and the MAs are new and scientifically profound.
-Raising cash after priority review designation (coming up faster than anticipated for the wide label)

Again, regardless of the true label
They are going for, I am relieved the adcom was not delayed and extremely looking forward to November.