Amarin Corp Plc (AMRN)

[jessellivermore]

No MO..

"That is all ANCHOR entails, an expansion of the label. There is nothing in the sNDA request about statins"

Unfortunately this statement is not correct...ANCHOR was dyslipidemia patients on statins..And as the briefing docs say, the issues are lipid altering add ons to statins. To whit, is there enough evidence, scientific or clinical, to support the ANCHOR indication (dyslipidemics on statins) prior to a positive REDUCE-IT trial.

The thing AMRN has going for it is the safety factor. The FDA is very tuned into risk benefit analysis..With essentially no safety issues, the FDA will consider the scientific evidence supporting V's
benefits which exceed mere trig reduction and IMHO conclude the potential benefits particularly in T2 diabetics in a drug which is extremely safe, justify it's approval for the larger group..even if currently the clinical proof is somewhat controversial. The total annual cost of T2 diabetes in the USA is estimated at over $200Bil..


Also board posters seem wrapped up on the panels voting..The panel vote has no binding effect on the FDA...Everyone might vote for approval and the FDA could deny it (1992 Silicone Gel implants) or vice versa.

":>) JL