Amarin Corp Plc (AMRN)

[go seek]

You seem to be a bright fellow HDGabor...
Thank you for your posts.

Bottomline the FDA is hesitant to approve another TG-lowering drug since several failed outcomes studies in recent years. And the FDA does not give weight to the positive sub-analyses within the HTG population.

The SPA essentially was out the window at ADCOM... The question placed to the panel was leading...

Amarin's strongest argument (other than the fact that Vascepa works) is that the FDA's argument that 'the science' has changed is flawed. The argument by the FDA (that rescinded the SPA) is vulnerable.

We know that Vascepa is about more than lowering TG's. Amarin is working (w/ studies) to show the FDA the MOA of Vascepa... this is important. Lot of moving parts here.

I am not surprised the appeal was rejected at the ODE-II LEVEL.
My hope is Dr. Jenkins (New Drugs) and/or Dr. Woodcock (CDER Director) take a more wholistic and patient-centric view of Vascepa.

If you have thoughtful comments, best if you submit them to the Citizen Petition

http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2013-p-1612;fp=true;ns=true

also write the following at the FDA:

Dr. Margaret A. Hamburg, FDA/OC
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Fax: [phone]
Email: [e-mail]

Dr. Janet Woodcock
Director CDER
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Fax: [phone]
Email: [e-mail]

Dr. John Jenkins
Director, Office of New Drugs
DHHS, FDA, CDER, OMPT, CDER, OND
Building WO22, Room 6304
Silver Spring, MD 20993-0002
Phone: [phone]
Fax: [phone]
Email: [e-mail]