Amarin Corp Plc (AMRN)

[north40000]

Time to go public with some ideas I PM'd to go seek in the last couple of days.

1st PM from me, a Washington patent attorney who knows only a little about FDA but perhaps more about bureaucracy:


"...The thought occurred to me that it might be desirable to contact the FDA directly, if possible, apart from or in addition to the various letters now near final draft format, between now and PDUFA date. Attorneys in Washington familiar with FDA substantive and procedural law, regulations and guidance might be helpful in the rather unusual situation AMRN now faces.Should the company and shareholders agree to explore that possibility, I have assembled a small list of firms with the help of an MD, JD who is engaged in FDA regulatory matters on behalf of a major international company in pharma/device matters. I am forwarding the list to you as the principal collector of lists, FWIW:

1)Covington & Burling---http://www.law360.com/articles/407786/life-sciences-group-of-the-year-covington-burling

Richard Kingham contact person

Covington&BurlingKingham[click to make link in browser] I personally know that Covington in the past represented GSK in an anti-trust matter---I worked with Covington on the case years ago. OTOH, Chris Sipes, a patent attorney personally known to me at Covington, appears to have represented AMRN before the FDA in its NCE matters with Kurt Karst below. Present conflict of interest?---I do not know.

2)http://www.hpm.com/vattorney.cfm?RID=22.0 Kurt Karst

3)http://www.sidley.com/bass_scott/ Scott Bass

and, for warning and more fun:

4)http://www.gsk.com/about-us/corporate-executive-team.html

Dan Troy is a formidable adversary if he is anywhere behind the scenes in the Vascepa matter on behalf of GSK...."


2nd PM:

"...Our friends on this board are not thinking straight yet.

1)For financing Reduce-it and other things, what about BASF, the world's largest chemical company and the supplier, I gather, of the stuff that ultimately goes into the Vascepa capsule. Seems to me that kind of financing is worth exploring. Or would BASF make plenty of Euros simply supplying a generic market carefully contrived not to infringe AMRN patent moat? I have seen no one mention this financing moa.Presumably, BASF would like to see its customer AMRN grow much larger.

2) class A meeting. Assume that is possible and can be arranged, back to the attorneys I sent you on that list. Explore a contingency fee arrangement with any of them. Add to that list one more:

http://www.goodwinprocter.com/People/H/Heller-Mark.aspx

My close friend I mentioned has worked with each of them, and regards Mark Heller as one of the best tho' lately he works for clients in the device field. Mark I am told has much experience in agency negotiation matters:

...."Mark Heller serves as chair of the firm’s FDA Group and is a member of the Life Sciences Practice. He focuses on the Food and Drug Administration’s and Federal Trade Commission’s laws and regulations, and in the FDA context, assists clients with strategy development, the premarket submission process, compliance issues, enforcement matters, development of legislation, and administrative and judicial appeals.
....

3)If BIO or Pharma get involved in helping AMRN now that FDA has rescinded SPA, it would not surprise me to see those organizations choose counsel from above. Any word in their plans?































































































2nd PM from me to go seek: