Replies to post #127347 on Amarin Corp Plc (AMRN)

[sharonc]

Victoza did run and complete a CVOT. All new diabetes and obesity drug are required to run them.

[ralphey]

THis was the whole issue with the ADCOM the FDA moved from the idea of lowering markers to actual outcomes - however they only did that for certain markers ( ie trigs) the FDA invented a new scientific standard at the ADCOM suggesting trigs played no role in CAD but presented inadequate science to prove their point. Ironically after suggesting that trigs played no role in CAD the FDA continued to suggest to all Americans that a low trig diet was necessary for good cardiac health. Subsequently , the FDA allowed certain drugs to be approved for lowering markers ( specifically LDL ) without any outcomes studies - since the mechanism of plaque genesis is not totally understood the schizophrenia of the FDA is apparent - either require outcomes studies for all meds involved with the prevention of plaque formation and CAD - or use markers -

Either we understand the mechanism totally and we know which compounds are responsible for the disease and thus can use marker reduction

or

we dont understand the mechanism and therefore using marker is inappropriate and outcomes studies are necessary

the FDA said ...we dont understand the mechanism but we will choose which markers are important ....this makes no sense