Replies to post #5197 on Amarin Corp Plc (AMRN)

[Biobillionair]

Yes,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122886.htm


New "COVER FORM FOR THE TECHNICAL REVIEW
OF DRUG MASTER FILES"...looks like a form cover sheet to help the FDA organize. As noted in the last post it mandates CAS and chemical name organizing into categories of "new" chemicals and chemical that have already been approved.

At least in my research I never noticed a CAS number for Ethyl Esters of Omega 3. All three Worldwide agency's for naming chemicals have separated Lovaza and Icosapent Ethyl, in my opinion, evidence of the FDA's final conclusion to Vascepa NCE status.

Will