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I disagree in part with your thinking. We don't know why Mgmt dropped the appeals process as Thero never gave us the reason. I do agree that the appeals process should have continued, if they had we might have exhausted all appeals by now. This lawsuit has no merit, and aren't we waiting to hear the outcome of another investor lawsuit in the meantime?
Based on the response to the petition, the FDA basically said, screw you mr patient, mr investor, scientist, doctor or whoever you are. Unless Amarin is willing to pursue the appeals process, we ain't changing a thing.
We the public may have a voice but so far it's fallen on deaf ears (congress, FDA) so imho our only hope for meaningful resolution is thru the courts....but only if Amarin management pursues it.
I'm all for it if the path is affordable...however the best we could expect is the continued rejection of the appeals process no doubt with the same response as found in Ma's citizens petition. Then at least the evidence would have to be reviewed by a court of law, and hopefully the prevailing judge would not buy into the FDA's bs. But will the company pursue this avenue?
This denial is a total sham. 1) refusal to overturn decision to rescind anchor spa because the sponsor did not continue to act on the appeals process? Are you kidding me...the appeals process is a friggin joke. 2) we can't explain the 3 trials used as justification for scientific evidence used to rescind anchor because it directly affects an unapproved application? WTF is that? And 3) the adcom was clear and concise on the voting matter? The FDA is a total lie. This is injustice at its finest!
Done!....again!
Would hope with a positive NCE decision, they then push for label expansion....
Turn up the volume..he does definitely say prevent but corrects himself and says present. Biggest Adcom fiasco I've ever heard or seen.
Win NCE, then goe for their throats...sorry ass FDA. Whether it ends up being a 1st amendment challenge to make anchor indication available to high Tg population, or anchor lawsuit without the remaining bs appeals process, I just hope Thero takes it forward. Cmon Moss, right this wrong!
Since both parties agree on the material facts and have requested a summary judgement, then is it common for a judge to hold the motions in abeyance? Would seem so if the judge is unable to make a decision on the spot.
JL, looks like the honorable judge Randolph d moss worked with the DOJ for a few years....
Not at all. Not sure why you come to that conclusion. HD ask for facts that the judge could see, and in my opinion the 8k is a fact. Why do you keep insisting that the judge will rule on the SPA? JL understands my argument and agrees, hd understands my argument but does not agree. You don't understand my argument at all. Perhaps JL can do a better job of explaining this to you than I'm able to.
HD, I am at a loss as to what you mean by factual Because, through the Internet, one can easily find the 8k filed by Amarin announcing the FDA's decision to rescind the SPA which clearly describes the reason for rescindment being "substantial scientific evidence"' which then is described as outside studies involving the lowering of tg's not resulting in a decrease of cv events...and the subsequent appeals. Is this not factual? Why would a judge not see this and not concern himself as to a pattern of FDA animosity (for lack of better words) toward Amarin?
HD, after extensive research, I have realized my error, and that is the difference between the federal judicial system and the civil judicial system. Investigations can only be conducted by the executive branch, not the judicial branch of the U.S. govt. So a federal judge ordering an investigation or conducting one on his on per se is outside of his role, unless requested by either of the two parties. However, I still believe that research of the NCE by the court (research of the evidence) not investigation, could lead to a favorable decision for Amarin.
Excellent!
You keep making statements that aren't true. You said judges can't investigate, I just showed you one of many examples, you said judges can't use the Internet....wrong again, I just showed you examples of govt entities on the Internet. perhaps you should refrain from making broad statements.
Federal judge orders investigation....On Monday, a Texas judge who temporarily blocked Barack Obama's illegal executive amnesty determined to postpone his final ruling on the matter in order to investigate how the administration was able to hide giving 100,000 illegal immigrants three-year amnestie
Read more at http://freedomoutpost.com/2015/03/federal-judge-orders-investigation-into-obama-administrations-illegal-amnesty/#178JsCWVf3Lx6tqK.99
It's been my experience in civil matters that when a judge is trying to determine a case he has assistants/staff doing the research on case law, evidence at hand, and whatever sources he and his staff determine to help with the case. It is within this research they may find fact that may or may not be of help in determining the case. Not saying he is employing investigators outside of his legal staff but I'm sure that's an option at his disposal. But what if he did find improprieties on the part of the FDA in its dealings with amarin not specific to NCE, is that totally ignored? Is it possible that at least it might influence his decision?
How does the court determine the validity of the evidence admitted?
RA, no disrespect, but your lack of ability to research information about Amarin and the FDA is limited by your actions shown on this board, and that is to ask other board members for information that you could easily find .....yes on the INTERNET also known as the world wide web. as a matter of fact, all US government agencies use the Internet to provide information to the public, including the FDA (see Fda.gov), epainitive, Amarin.com, orange book (yes that's available via FDA.com) etc etc. Yes , the media as well, yes to public forums. Secondly I have never said the judge would rule on matters outside of NCE! So your example of using whatever for Exhibit A has no merit.
It's really difficult for me to respond to your attacks with civility, so this is my one response to you and hopefully my comment won't be removed by the moderator.
The court has access to a plethora of information regarding the case of NCE involving Amarin and FDA Others have scoffed at the idea that the court has and would look at information available via the Internet for example. So understanding the history between the FDA and Amarin would not be too difficult based on the many events that are public knowledge. Whether the judge and his staff determine the information to be relevant or not remains to be seen, but one can not dismiss entirely the idea that the court could be influenced by the FDA actions that appear so improper towards Amarin. What's the relationship between the SPA and NCE? The drug for one, and the two parties for two. To me the evidence shows an FDA prejudice towards Amarin.
Not saying Moss would rule on anything outside of NCE. Am saying that factors outside of NCE such as anchor spa fiasco may very well influence his decision. To say that he and his staff are not aware of these outside factors is just plain shortsighted.
HD, a few on this board have told me that the judge can't even consider or research anything outside of NCE. I believe otherwise, especially the lame ass adcom for the anchor spa and now as BB has pointed out, this outrageous censorship of the epainit cp.
Read the label "it is not known if Vascepa prevents you from having a heart attack or stroke". I understand this to be a major issue for the FDA, and that is the approval of CV drugs that aren't not known to reduce CV events and they want to change this. However, I don't believe that this change in position on the FDA's part should grandfather in drugs that are already approved or in trials such as anchor where millions $ have been spent and patients have seen improvements in lipid panels. Anchor should never been rescinded, it was a poor decision on the FDA's part, and as a result a lot of trust and confidence has been lost on the FDA by the American public.
"reduction of CVD events"....sure that's the end goal, but like many other drugs, my bottle of Vascepa says " it's not known if Vascepa will result in lower CVD events"....or something to that affect.
I' m thinking the same...NCE is the litmus test. A favorable outcome would be an expanded label with the requirement reduce-it be completed....as others on this board have suggested.
I just realized I misconstrued your first statement about assumption. However, the FDA still made a change by introducing the "reduction of CVD events" after anchor was completed.
I would find it hard to believe that the word "assumption" would be used in a legal document such as the SPA and the lowering of TG's have long been thought to decrease CVD. Basically the FDA made changes without notifying Amarin until ADCom which you know took place after anchor was completed, and that in my book is totally unethical.
So HD, are you saying that the Anchor SPA was written and agreed upon by both parties to include vascepa's effectiveness by measurement of reduced CVD? Because I thought reduced CVD was the primary measurement of reduce-it, not Anchor SPA. If the game plan changed, FDA never notified Amarin that I'm aware of....and that is also part of the SPA language...to notify of changes to the agreement.
So 1Bil, is the FDA like that scene in the movie Prizzi's honor where the old mob guy says "a Prizzi never forgives"? If that's the case then we'll have to bring the heavies....
Zu, where were you when I was going through my divorce? You're interpretation of contract and agreements would have put my ex wife, her attorney and the judge to shame! Heck I would have had more $ to spend on Amarin...dang it. Lol
Kiwi, by the FDA's definition of a Special Protocol assessment and Agreement, the word "binding" is used extensively. That would indicate a SPA is more contractual in nature.
Seems like investing in a biotech stock that has to work with the FDA is no different than investing in a company doing business in a banana republic. No matter how well you line their pockets or play by their rules, you are at the dictators mercy....
mrmain thanks for being open minded. Why some posters don't believe the judge could possibly be aware of the other FDA interactions with Amarin like anchor spa is beyond me.
Thanks JL for the advice. The honorable judge moss would have quite a chuckle over what some of the posters on this board would tell him what he can and cannot do...especially when it comes to connecting the dots....
JL, perhaps you could enlighten rafun on this subject, my attempts have only been responded with insults.
So based on your thought process, there is absolutely no connection between the handling of the anchor spa and NCE by the FDA right?
There is no pattern of similarity in the FDA's behavior toward Amarin. And of course, because the SPA appeal was dropped, because the FDA rescinded the spa, no one is aware of this activity, not even the judge or his staff? And the only way to have been aware of it was through news outlets?
mrmain, again I'm not contesting the fact that this judge is limited to ruling on NCE only, but what I am trying to convey is that the judge is not limited in knowledge to facts brought up only by the two parties. Through research (and it is not limited to applicable law only), the judge may be aware of the anchor spa issue. Could this influence his decision? Could he make comments on it?
If in fact a judge was not allowed to research/investigate a case, and only concern himself with the facts brought up by both parties, then it becomes a "he said, she said" situation. Why did the judge tell both parties to provide him more information by last Tuesday?
A short description of a federal judges scope follows:
Research by the court itself on background facts and law
is often necessary. The court should make the parties aware of
its independent investigations—and the sources utilized in any
such investigation—so that the parties can correct
misconceptions. Limitations on formal judicial notice in the
Federal Rules of Evidence do not apply to this research.
Zu my posts have been quite clear, the ruling is on NCE and NCE only. Does that mean the judge is not aware of anchor spa? Does that mean the judge has a gag order on himself not to comment on anchor spa or any other misgivings by the FDA? Just because Sipes and the FDA did not bring up the anchor spa issue does that make the judge unaware? Is it reasonable to consider that the judge and his staff have researched/investigated this ongoing NCE issue between FDA and Amarin and in the process discovered the anchor spa issue?
obviously my comments are lost on you. Tell me how the judge can make a ruling on NCE without investigating the matter at hand.
Louie: I did not say the judge was investigating other issues. I said during the course of investigating the NCE issue with amarin and the FDA, it's a no brainier that the judge and his staff can "discover" other issues such as anchor spa. He cannot rule on anything but NCE, but again that doesn't preclude him from communicating his knowledge of the anchor spa matter.