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NCE Delay:
After all this time..
It's probably been determined by now so:
If it's "no", then why wait, tell us now...AMRN doesn't have time to sue and whine over it because they have a drug to launch, so why wait to tell...and all big pharma's will be pleased anyway..
If it's a "yes", then big pharma's gonna challenge that and sue or make problems for FDA, so probably need more time to prepare for that..
It just seems like a "yes" eventually while the argument builds weight to battle the backlash of "yes" from other pharma's.
I could be desperate here with my thinking, but its getting crazy and deductive reasoning is all I have...
Anyone know what time Orange Book will be updated? Will it be Friday AM or Fri after market closes? Any help would be great..
Arguments in Arnold vs Dudas case...
They mention a drug that contains parts A and B can get NCE if both parts of A and B have not previuosly been approved individually...Lovaza has parts A and B...Vasccepa has only part A, and This part A has not been previously approved for its unique active moiety individually.. So Vascepa may have a shot at NCE based on court interpetations of the FDA language in the past...
Old blurb but nice to read...
Over past 48 hours I have referenced several FDA attorneys as well as the work of a biochemist that wrote the actual patent data found in Amarin's key composition of matter patent. I am very confident that AMRN will gain NCE status based on FDA characterizing the active moiety different than that of Lovaza. On its face, it appears a close call and fairly complex since Lovaza is made up of DHA and EPA. However, FDA has decided that that combination of those elements work as ethyl esthers. Once you understand the mechanism of action and what AMRN found with their compound that Lovaza did not, it actually becomes much more clear. Currently, the FDA does not have any approved Rx containing icosapent ethyl alone or in combination as active moiety. The key is icosapent ethyl and it is not found alone or in combination. Period.
Old court case involving "active moiety" and NCE situation...scroll down to bottom paragraphs to see some arguments..
Federal Circuit Denies Rehearing Petition in LEVAQUIN Patent Term Extension Case
By Kurt R. Karst –
Last week, the U.S. Court of Appeals for the Federal Circuit denied Lupin Pharmaceuticals, Inc.’s (“Lupin’s”) Petition for Rehearing en banc of a May 10, 2010 panel decision in Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc. in which the Court affirmed a May 2009 decision from the U.S. District Court for the District of New Jersey that the Patent Term Extension (“PTE”) granted by the U.S. Patent and Trademark Office (“PTO”) with respect to U.S. Patent No. 5,053,407 (“the ‘407 patent”) covering Ortho McNeil’s (“Ortho’s”) LEVAQUIN (levofloxacin) is valid. The Court’s May 2010 panel decision, which was issued on the same day as the Federal Circuit’s decision landmark PTE decision in Photocure ASA v. Kappos, and the Court’s July 2010 denial of Lupin’s rehearing petition leave standing an interesting dichotomy with respect to the treatment of single enantiomers in previously approved racemates insofar as the availability of PTEs and New Chemical Entity (“NCE”) exclusivity are concerned.
Levofloxacin is an enantiomer in the previously approved Ortho racemate drug product FLOXIN (ofloxacin). Lupin initially challenged the ‘407 patent PTE in the context of ANDA Paragraph IV Certification patent infringement litigation on the grounds that the PTE is invalid because FDA previously approved the active ingredient levofloxacin when the Agency approved the racemate ofloxacin. (See our previous post here.)
Under the PTE statute at 35 U.S.C. § 156(a)(5)(A), the term of a patent claiming a drug shall be extended from the original expiration date of the patent if, among other things, “the permission for the commercial marketing or use of the product . . . is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred.” The term “product” is defined at 35 U.S.C. 156(f)(2) to mean, in relevant part, “the active ingredient of – a new drug, antibiotic drug, or human biological product . . . including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient” (emphasis added). (The term “active ingredient” is defined in FDA’s regulations to mean “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure of any function of the body of man or of animals.”)
For several years, the PTO had interpreted the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean “active moiety” (i.e., the molecule in a drug product responsible for pharmacological action, regardless of whether the active moiety is formulated as a salt, ester, or other non-covalent derivative) rather than “active ingredient” (i.e., the active ingredient physically found in the drug product, which would include any salt, ester, or other non-covalent derivative of the active ingredient physically found in the drug product). In contrast, the Federal Circuit’s 1990 decision in Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 13 USPQ2d 1628 (Fed. Cir. 1990) (“Glaxo II”), construed the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean “active ingredient.” The Federal Circuit’s May 2010 decision in Photocure and Ortho-McNeil, both of which concerned the proper interpretation of 35 U.S.C. § 156(a)(5)(A), ruled that the Glaxo II decision and its “active ingredient” interpretation of the PTE statute should be applied for PTE purposes.
In contrast, FDA has for decades, treated single enantiomers of previously approved racemates as previously approved drugs not eligible for 5-year NCE exclusivity (but eligible for three-year new clinical investigation exclusivity). For example, FDA stated in the preamble to its 1989 proposed regulations implementing the Hatch-Waxman Amendments that “FDA will consider whether a drug contains a previously approved active moiety on a case-by-case basis. FDA notes that a single enantiomer of a previously approved racemate contains a previously approved active moiety and is therefore not considered a new chemical entity.” FDA still adheres to this policy today, although the FDA Amendments Act of 2007 amended the FDC Act to add § 505(u), which permits the sponsor of an NDA for an enantiomer (that is contained in a previously approved racemic mixture) containing full reports of clinical investigations conducted or sponsored by the applicant to “elect to have the single enantiomer not be considered the same active ingredient as that contained in the approved racemic drug,” and thus be eligible for NCE exclusivity.
The dichotomy between the treatment of enantiomers in previously approved racemates with respect to PTE and NCE exclusivity eligibility was at the heart of Lupin’s Petition for Reconsideration. Lupin argued that:
The FDA and PTO abused their discretion when they applied two conflicting interpretations to the same words – “active ingredient” – in the same legislation – the “Hatch-Waxman Act.” Thus, the district court and the panel erred in failing to consider the important legal issue: what the term “active ingredient” means and how it should be applied to enantiomers. The Court should grant this petition for rehearing en banc to adopt and apply a consistent definition of “active ingredient” and to reverse the district court’s determination that the [PTE] was properly based on the approval of LEVAQUIN®, which contained the previously approved enantiomer, levofloxacin, as its active ingredient.
Lupin also relied on the Federal Circuit’s 2004 decision in Arnold Partnership v. Dudas to build its case. In that case, which concerned the availability of a PTE for a combination drug, the Court ruled that “the [PTE] statute places a drug product with two active ingredients, A and B, in the same category as a drug product with a single ingredient . . . . To extend the term of a patent claiming a composition comprising A and B, either A or B must not have been previously marketed.” In reaching its decision in Arnold Partnership, the Court relied on FDA’s regulations to construe the term “active ingredient” as used in the PTE statute. Applying the concept that “[w]hen the same term appears in multiple locations in the same Congressional Act, it is generally considered to have the same meaning each time,” Lupin argued (unsuccessfully) that “the term ‘active ingredient’ should be construed to have the same meaning when it appears in the [PTE] provisions of the Hatch-Waxman Act . . . and in the new product exclusivity provisions of the Hatch-Waxman Act,” such that the PTO should have considered levofloxacin to have been previously approved in ofloxacin and not granted a PTE with respect to the ‘407 patent covering LEVAQUIN.
Also...
They did not mention hiring a salesforce..only managers..great sign.
Trust me folks..no news today is good news..I was expecting salesforce hiring news which would be devastating..and we didn't get it..soo its NCE news time next week and we'll have clarity then...Good luck
New language in PR...
This time they ackowledge the fact that NCE "may" ultimately determine the final direction of the 3 previously stated pathes...aquisition,partnerhsip...etc...
This is new to me, which I interpret as "yes" a big pharma is definitely waiting for NCE status for final valuation...they have not stated that in previous corespondeance...
thas just my opinion..sorry for crappy spelling..in rush
So in the meantime, any idea of what the hell they are doing?
Cannacord sticking to it's $26 PT / Buyout story... from fly on the wall..
These SA articles are pathetic. Check out their websites and google these people, they are total frauds.
Even the comments from the article seem to be from "normal" contributors, and when you look them up, you get routed to these home made websites for some " blah blah Capital Management" in NY City..
These people need to all get choked out.
Maybe his detective can help me find out why my girlfriend keeps letting the UPS guy inside the house when I'm not home...Hmmmmmm
Too funny.
I email IR yesterday, and the guy responded within an hour that they were in a quiet period. It's not an SEC related quiet period, but probably self imposed (whatever that means..). Go to the website and email IR. I'm sure you'll get the same response I did..
Amarin is in quiet period according to IR. Would not say anything more than that...I believe its just MM's trying to make volume until some sort of news. Prepare for more boring slow BS price decline(possibly) until something happens..I don't think it is going to plummett, but I do think it will just bounce around these levels until some news is out. Just hang tight..
Yesterday the price moved 10cents on 1000 shares..That tells me low volume bull$hit price movement based on the fact that nothing is happenning..
Just sit and wait and buy on big dips..
Haven't looked here in some time. Looks like someone did know something after all.
Laky is a douchebag. I've got some capital gains to offest, so I will finally start selling this stock.
Total loss $54,000
See you guys and gals around. Its been great dreaming with all of you. I'll be hanging around the AMRN board and $heff station for the next few months.
Good luck to all!!
Goodbye.
Very exciting stuff..I really hope they get bought out. What effect on Share price do you think a partnership announcement would cause vs a buyout?
This guy doesn't write anything decent about anything. Look at all of his stories..most are all negative. Negative gets people to read, so thats what he sells.
Its very annoying. He leaves out a lot of information on purpose and writes like he's "playing dumb". "Uh OH everyone, No NCE can't be good, means that they don't get bought out"
He's a F%cking moron,
Get lost.
The only thing that will be different is the expensive bill you will have for all that Dom.
I think its BS..so disregard about that CNBC thing...just the ongoing long short war on the YMB...full o crap-ola!
Anyone hear chatter abount CNBC announcing news on NCE after the bell.. I'm hearing that from YMB..but I take that with a grain...anyone know?
Nice comment from Management about "expecting to receive NCE status:...they do say "or the 3 year status,etc"..but they led with the "expecting" word which was nice!!..
they seemed confident and it gave me confidence!!
For those of you that check out the Yahoo Boards...
I finally set up a username,etc and signed up. I used a fake name, fake everything, and got in no problem. (just cause I have enough of my real info out in cyberspace already)
THEN...
YOU USE THE IGNORE FEATURE for anything posted in all CAPS!!! or just the same a-hole bashers..
And i gotta tell ya...its is so worth it and actually pleasant to visit. I'm not a blind pumper..I just like a nice filter to get news links and other bits and pieces from the people that do post.
I highly recommend!
Does anyone one know how the NCE status information will be released on the 17th? Will it be PR'd or will it just be updated on the FDA website.. if anyone has any experience with this it will be much appreciated..also..what time will they most likely announce or release this?...TIA
Anyone have an idea of how low they think this will go?
The only one that seems to know something is that janitor from Adam Sandler's Billy Madison:
"Ms Libby drives a green car"
I think he now works for Medclean...
I still feel good about it considering my Cbasis..
I'm an idiot..$1.10 (sorry) I would have bought 300 contracts, if they were .10 my bad..
My cost basis is $9.50, and I bought the August $11 puts for .10 just to be safe and covered my a$$.
I figure that if they don't get approval or delay then price may get shot below $10 and if not then great, I'll hold..;)
Don't read too much into it. These guys have lives too, and they have every right to sell some of their holdings to diversify themselves. For a lot of these guys, it is the only source of wealth they probably have and cashing in could seem prudent.
Also..they aren't going to risk being caught selling if the information that comes out after is bad, meaning that they make a decision to sell when they don't know if the next round of news is good or bad, just like the rest of use (in theory).
I'd be concerned if they sold everything!!, but what I saw did not make me concerned. The institutional holdings mean more to me anyway, and those guys aren't selling.
It seems all the chatter is basically saying... Why would the FDA make them do an outcomes study that will cost them $127,000,000 , and not grant them NCE status? I think they will get NCE status. IMHO
Maybe with a few strings attached, but it will be good, either way.
...a match to burn his place down and collect the insurance.
Another steak dinner traded today....
Gee Wally, you're being a little too hard on the beav?
Burn the little shorties pants off!! Very nice to see this today..
I thought Laky was deaf...so I signed all of my questions on the conference call, but no one responded, then they hung up on me..I was so sad that day..so sad. :(
I hope his gun is pointed at my head..to put me out of my misery..
If AMRN gets a 90 day extension for FDA approval, does anyone have any pps predictions? It will drop, but it will only be temporary, IMHO.
Any thoughts would be appreciated..
I think the conference call was actually conducted in the bathroom at the olive garden, great way to save money.
SOMEBODY KNOWS SOMETHING!!
Any shorts on this board? Let's meet up and have a chat in person..