Amarin Corp Plc (AMRN)

[jessellivermore]

Sam81..

Thanks for the post.

I was unaware of any exception cited in the H-W exclusions. Of course I would defer to the FDA Law blog.

Your post mentions the DEA scheduling determination which refers to how a drug might be classified in terms of its addiction potential, and narcotic analgesic potency which are separately evaluated by the Drug Enforcement Agency...Kind of like a mini rerun of the FDA process. This unquestionably takes time and shortens the H-W exclusions and the exceptions may be reasonably based these facts..

The Amarin situation does not involve the DEA, and I am unaware of a situation where the FDA's inability to decide the NCE, or a court reversing the NCE resulted in the NCE exclusion commencement being post dated. The H-W exclusion were put into place to balance the concerns of drug initiators which develop the drugs and the generic companies which function to lower the cost of drugs to the public. First of all in no measurable way has Amarin been denied its exclusion rights to this date. The notion the NCE designation would lead to an immediate sale of the company which some claim, is fanciful and not provable. We have been awarded the exclusion by the courts, regardless of whether or not it says so in the OB...The FDA has put all generics on hold..

If the possibility exists, and I doubt it seriously, the FDA could and did extend the API exclusion past the statute...The FDA will be sued by every generic company with an eye to marketing EPA...and for good reason. Why should they have their rights abridged because the FDA made a mistake.

":>) JL