Amarin Corp Plc (AMRN)

[jessellivermore]

Bb..

Quote: "Can you share your opinion on SOC and malpractice?"

Yes.. SOC in Medicine is a legal term relating to negligence...Negligence does not imply perfection,it refers in "med-mal" to the idea of taking the necessary safety precautions that a competent physician would take. And provide medications and procedures that offer the patient the greatest therapeutic benefit available in a given clinical situation..(my words).

Malpractice is defined as practicing below the Standard of Care...This is in most cases relatively easy to determine as the physicians is careless and fails to take proper steps omitting the necessary or lacking the knowledge to treat the condition correctly...In reality things are often much more complicated ...and juries tend to consider the health and financial losses the patient has suffered and award accordingly and not so much the actions of the physician.

The SOC obviously brings into question the importance of what the authorities consider safe and effective...And some practical considerations..including cost benefits..

The issue here is FDA is considered the ultimate authority on safety and efficacy as far as drugs and devices are concerned..And this authority is given by congress..Whether or not FDA "practices medicine" is open to debate..As a general rule and in almost all cases FDA grants approval of a drug for a given indication by issuing a drug label which lists therapeutic benefits and safety concerns...It is true indidual doctors can and are encouraged by FDA to use drugs "Off Label" (OL) for other indications...But neither they nor the company that manufactures the drug can market these drugs for the OT conditions without FDA approval. And that is why we are waiting for the sNDA label change...

I'm not sure a drug which is not approved by FDA for the indication and is being used Off Label...can be considered SOC..(Please don't go bonkers...I'm not giving an opinion..I'm confessing I'm confused.)

So I don't know how this ADA pronouncement that V is SOC for T2DM, on statins, at CVD risk and moderately high trigs...Will sit with FDA..Obviously as a guy with an obscene amount of money and shares in Amarin...I hope it becomes law of the land tomorrow...The same for the PR in Canada...I hope with all the rest of you that FDA just realizes it is not keeping up with medical reality and says nothing and joins the party...I do think FDA will expedite The PR decision in Amarin's favor..and grant the sNDA in record time...

":>) JL