Replies to post #184971 on Amarin Corp Plc (AMRN)

[Biobillionair]

JL-

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...

I'm in the same boat...I'm not getting any feed back from Woodcock since I gave her the Canada PR...I can only hope the FDA doesn't want to be the last one to realize the significance of the R-I results.

BB

[rfj1862]

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.)

It's very common for drugs to be used off label and be considered standard of care. As someone else mentioned, nearly every drug in the neonatal ICU is off-label, yet considered standard of care. Furosemide does not have an indication for prevention of morbidity and mortality in patients with heart failure, yet it is considered a standard of care. And there are hundreds of examples of standard of care drugs in oncology that never got a formal indication.