Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
You must really have a low opinion of the judge and his staff to assume they have no knowledge of the anchor spa situation. Tell me this, how can the judge and his staff not be aware of anchor spa in their investigation/discovery of NCE? Please don't tell me again that a judge and his staff don't "investigate"... That's just plain ludicrous. Why has it not been mentioned in the transcripts to this point?....because it's about ruling on NCE...but that doesn't preclude the judge from communicating his knowledge of the matter to the FDA and Amarin when he rules on NCE. This communication can come in the form of "advice" or as others have pointed out...his obligation to notify legal authorities of malfeasance/ misconduct on the part of the FDA.
JL, those have been my exact sentiments all along as well, this judge is not blind to the FDA's handling of the anchor SPA and has the discretion to advise on it. I'm amused by some of the posters on this board who believe he is not allowed to "discover" other malfeasance outside of NCE through investigation of NCE itself.
Maybe you should reread my post. I said the judge can only rule on NCE but that does not preclude him from making comments about other matters between the FDA and amarin, which he is certainly aware of from doing his due diligence. Please review " the roles of federal district judges" in brook law for clarification. Also, this matter is being decided by a judge, not a jury so restraints that may be imposed on a jury are not necessarily imposed on a judge.
Ra: "a judge does not investigate"? Why do you think he has a personal staff working for him...maybe you haven't been involved with a lawsuit before?
HD: although I agree that judge moss can only rule on the question at hand..."NCE", I believe that his staff has done their homework and are aware of the anchor/spa fiasco and epadi cp. If they have seen the flow of information on the two subjects as we have which is readily available on the Internet, I would have to believe that the judge may have more to say....which might result in the FDA taking an initiative to take a closer review of anchor Or encourage Amarin to continue appeal/lawsuit.
Rose that article is a bit dated...some of their comments imply that it was written before February 2015.
"Consistency" is the key in my opinion. If the FDA can flip flop on guidelines and interpretations then who in their right mind would want to invest $millions in drug innovation under the FDA's watch? Much like the SPA....
Honorable Judge Moss can suggest action regarding Anchor Spa to both parties. Although his ruling is limited to NCE, it is within his wisdom after evaluating the case that as mentioned before, a pattern of questionable actions by the FDA, can be expressed to both parties and in fact, he can suggest Amarin file a separate lawsuit but the court would hope that an amicable resolution between the parties could be arrived at. But based the the FDA's arrogant behavior to date, they would insist on the appeals process....again....imho.
raf: actually it is mentioned in the law360 article. However it does not say it was brought up in court, but I think if Amarin wins, it's very possible that anchor spa will be their next lawsuit (regardless of the phony unreasonable appeals process set down by the FDA).
HD: Three-year New Use/New Clinical Studies Exclusivity. New indications or dosage forms of previously approved drugs can receive new use or new clinical study exclusivity. The application must contain reports of new clinical investigations conducted by the applicant. The exclusivity term runs for three years from NDA approval and it bars the FDA from approving any ANDA or 505(b)(2) application by another party that relies on the same clinical studies. This exclusivity can be coupled with a six-month pediatric exclusivity.
Ajax: why complete reduce it if generics can pile on? What protection is afforded to Amarin if 5 year NCE is not granted by the judge?
Reduce it success should garner exclusitivity as it's an expanded patient population that only Amarin sponsored the five year study for. The current generic filings are for the marine indication only. If the generics were allowed to pile on reduce it positive results then that would be a total travesty.
I agree. One cannot sue for monetary damages, but one can sue for reversing a decision made by a government agency such as the FDA. I am at a loss though as to how the expanded label effort will fare if the judge rules in favor of Amarin regarding NCE. One might think the FDA would retaliate by negating any efforts for a label compromise as we have hopes for.
If you can't sue the FDA for a bad job then how can Amarin be in U.S. federal district court with a lawsuit against the FDA? Sovereign immunity applies to the negative effects of drugs on a patient, and this is not what this lawsuit is about, so yes you can sue the FDA for improper conduct or handling of the NCE.
Mr Thero, why did you decide to drop the appeals process for the anchor spa, the truth please!
I wrote to Hibberd asking for an explanation, wonder if I will get a response.
BB your're dreaming...please wake up and smell the reality!
Funny you should say that JL, I was thinking the same thing as i was typing my first response...just go generic. Actually though if you are amarin mgmt with limited resources, the only thing you can control is pricing, since their budget is limited for advertising and feet on the street. So if you could adjust pricing so that it came out cheaper than tier one generic. I mean it really does come down to adopting a strategy with limited resources that increase scripts substantially, and when people are thinking expansion outside of USA, that takes money, or of course we could pay the right people in the FDA like our competition does, but again that takes money...it would be great though to hear what's really been going on in the case of acquiring a partner...is there no interest? Or the price too steep..(think shark tank)? ??
Yes, amarin should determine if lowering the price gets them additional volume and tier 1-2 placement. Why is generic lovaza tier 1?
"One of the biggest names in cardiovascular therapeutics "? Since when did Amarin get this BP designation?
Eric g Colman...not Eric coleman
It is odd that the volume spiked today to the downside without any news...some one wanted out or took short term profit.....
Greed kills.....
JL, after listening to the sept 16 webcast on reduce it completion, Thero states he will not detail plans for the anchor appeal, although he recognizes the outrage expressed by elected officials, investors, clinicians and patients. He then states Amarin continues to work with regulatory, clinical and legal resources as to a course of action. What I find even more curious than the status of the appeal process, is the FDA's lack of response to the question of the sNDA....as Amarin has made repeated attempts to get a decision on this matter from the FDA to no avail. Why is the sNDA in limbo?
JL, perhaps another possibility to position this fiasco is for 60 minutes to do a segment on obesity/cardiovascular concern in the USA, delving into the argument of triglycerides having a key role in CVD....where the FDA is called out in their latest efforts to confuse the public with their rhetoric that outside studies have shown that the lowering of tg's does not lead to a reduction of cvd...contrasting that with other studies that claim the opposite.
Don't forget ajax, he's a major hedge fund manager as well as a physician and professor at a major west coast university...per his own previous posts!
Bid, Ajax aka Pinocchio is a fraud, and his only line of defense is to attack when asked simple questions....like why are you on this board if you sold all your position before adcom since it was a binary event? As if there haven't been binary events since then as well....sheesh I guess that makes me a perfect a hole for asking hard questions....and I guess his idea of contribution to this msg board is to embellish.
Right on ra, Ajax has the credibility of Pinocchio, Ladavis his side kick. I'm just surprised how many on this board buy into their bs....
Unfortunately, it's quite obvious that the FDA is not accountable for its actions and is omnipotent. This agency has the power to make the rules and change them on the fly. It's no better than a third world dictatorship. It seems crazy that the only way to introduce and market a drug in the good ol US of ObamA has to go through this sham.
Funnygi2' it's almost comical how some posters on this board believe this guys rhetoric. Simply amazing.
No, I just don't post a lot of crap without backing it up and being able to answer fairly simple questions without attacking the person asking the question.
Careful rafun, you question these guys and you get a lot of ridicule and spittle....
Ajack, obviously you are a fraud. At least I don't post bs.
Ajaks, why no response to the other questions? Are you holding shares of amarin? If not why are you here? What was the change request to the spa that the FDA wanted that amarin mgmt rejected?
Interesting your source didn't alert you to this issue prior to adcom and you did not mention on this board until recent. And what was the FDA's request to change the existing spa? And since you avoided the adcom debacle by liquidating your position on behalf of your investors because it was a binary event, why are you on this board? Did you liquidate again prior to Fridays announcement that FDA appeal being rejected since it again was a binary event? Inquiring minds want to know!
I don't see how the FDA can refute the language...after all, it's only stating the facts and not going too far by stating an indication.
Because congress is afraid of them or congress has been paid off....
To my way of thinking, since the FDA did not give Amarin anything on label expansion change or whatever you want to call it, which would have guaranteed completion of reduce it, then the FDA is not interested in reduce it, and is trying to wipe this company and it's drug out. Somebody(s) is definitely orchestrating this sham.
It's in the 8k filing this morning. Not enough evidence for the FDA in light of the recent studies/findings....
Assuming the fetal position with ones thumb in their mouth is not the way to play it Ajax. As far as I know, amarin has not released the latest reasons FDA gave for denying the appeal. Assuming the reasons haven't changed, and the latest science that's has come to light, perhaps Thero cannot touch the omnipotent FDA, but an enlightened judge can. See you in court Hamburg.