Amarin Corp Plc (AMRN)

[jessellivermore]

Nutsy..

Re: Doctors using Vascepa "off label"

FYI..Your statement: "Going off-label is NOT a good idea. The FDA frowns on off-label use big time," is incorrect.

The FDA does not give a dump about doctors "off labeling" drugs, unless you are talking about controlled substances. The FDA encourages off label use if it is felt appropriate by the doctor. The FDA leaves the decision up to the doctor. The caveat is that if you off label clinically then you are putting yourself at risk for malpractice if injury occurs related to the off label drug. One of the greatest attributes of V is that it has a pristine safety profile.

That said, what the FDA has hinted at is they may use the old quack cancer treatment criticism to defend their actions at the AdComm re: Vascepa. The argument would be that they fear V will be used to treat CVD and replace drugs with known benefits (??statins??). This argument actually goes against the FDA's stated policy which is to leave the doctoring to the doctors, and makes the argument that the FDA considers the doctors to be a collection of morons.

":>) JL