Replies to post #60237 on Amarin Corp Plc (AMRN)

[ggwpq]

Generic companies such as Watson would sue FDA immediately for such exceptional ruling and win.

[HDGabor]

S-

"The regulation does provide for an exception under limited circumstances" refers to a (final) approval (date).

"Some requirements that may remain after the FDA sends such a letter are ministerial and do not affect the finality of that approval. In those circumstances—including when the manufacturer will have to finalize a label to reflect DEA scheduling—the FDA does not need to consider further any aspect of the NDA and so it treats its “approval” as final."

- FDA did not include any requirement in the approval letter
- exclusivity determination (NME / NCE / no det.) does not effect the approval and / or label

Date of approval means the date on the letter from FDA stating that the new drug application is approved, whether or not final printed labeling or other materials must yet be submitted as long as approval of such labeling or materials is not expressly required. "Date of approval" refers only to a final approval and not to a tentative approval that may become effective at a later date.

FDA issued a final approval on July 26, 2012.

"Determination of whether this application qualifies for 3 or 5 years of exclusivity was not finalized by the goal date. The final decision will be made post-approval" post-approval = after approval -> V was approved. The start date of the exclusivity is the date of the aproval and isn't the date of the determination.

I think a lot of respected posters covered / check all aspect (btw: it is not a complex issue) and no realistic, legal scenario exist other than: NCE - 7/26/2012 - 7/25/2017

Best,
G

[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

[Biobillionair]

Hey Sam-

Judge Moss clearly lays this out in recent Eisai decision here:
"In other cases, however, the requirements that remain are substantial and will require further substantive review and approval. In those cases, the agency expressly requires further action in its approval letter as a signal that the FDA has concluded that its process is not yet completed"

https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2014cv1346-26

Amarin's application has not been completed, see my prior post.

IMO exclusivity will start when OB os updated, both FDA and Amarin where likely waiting for this decision to determine start.

Hopefully it was made final yesterday and be update Oct 15th or 16th.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117384888

BB

[ziploc_1]

Sam: I still have the naive belief that the law attempts to be fair and equitable. In the case of Vascepa NCE, the exclusivity denial(later reversed) has deprived Amarin of much of the benefits intended in the H-W statute. While the statute does not specifically address the situation of Vascepa, nevertheless an equitable solution requires some redress.