Replies to post #6270 on Amarin Corp Plc (AMRN)

[BioChica]

Great, Williams I was a bit concerned. It's seems this is heading in our direction. Chemistry is tough stuff. I am an experienced electronics technician class A, and worked as an engineer for a couple of Biomedical/Industrial Control Companies.

This has been a quite learning experience with FDA, NCE and OB Updates.

[zoobuffdoc]

Williams, Thank you for your great investigative and interpretive work. Gives real meaning to DD. It does seem to me that NCE is highly likely to be granted...if not this Friday, then next month. I think that patents cover exclusivity well, but all of this hullaballoo about NCE may lead to nice psychologically-based, in-the-short-run pop when it does finally arrive. My personal outlook is directed more towards Q1 2014 when most of the real catalysts and Rx trends will be available. I am "looking fo" (and hope to see!) a pps between 20 and 25 at that time. Best wishes to you.

[yoyo88]

BioBill, great post. Maybe you can help me understand one part I am not fully wrapping my head around. The new MAPP policy that we all hope proves change is underfoot, has some wording that for me, translates into a roadblock.

"Scientific evidence demonstrates the salt form affects the absorption, distribution, metabolism, and/or excretion (ADME) of the drug in a manner that influences the clinician’s product selection."

We all know V is far superior to L in terms of getting beneficial EPA to the body, no contest there.

But this policy is with regard to salts, and excludes esters, correct? Forgive the stupid question, but isn't V -- Icosapent Ethyl Ester -- which is not a salt?

I understand (mostly) what V is and what it does.
I understand (mostly) what this policy attempts to say.

I guess I just need help drawing a straight line between the policy changes and the stuff inside Amarin's little gold capsules.

Thanks in advance.

[SciGuy]

Yup, got all that. You sound defensive -- no need. I don't buy the "prodrug" argument. If FDA weights pharmacology more than molecular structural differences, then NCE is awarded. If form over function for NCE, then no dice.

Best regards.