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You and BC should be commended..
BB,
Now that we have NCE and stock options can be vested immediately in event of a change of control, Pfizer may acquire Amarin right after the REDUCED-IT results. This is because Pfizer will not repeat the Warner Lambert mistake twice; they will acquire earlier rather than later. Also having sued FDA twice the Amarin management would most likely not deal with FDA again. All that needs to fall in place now is the interim peek at the data. We are looking at June 2016 latest...
Thanks for clarifying BB. Appreciate it.
Yes Zetia.
Yes, or take all his time to cover all grounds so
that FDA find it impossible to win on appeal.
Anyone has a copy of transcript of oral argument?
Is it possible that the Judge delayed his decision so that
he issued a final Ruling instead of a preliminary injunction
since FDA is playing delaying tactics?
Caronia followed Supreme Court Decision of Sorrel!
Thank you for actually quoting it. FDA has simply discarded this Ruling. If not in District Court we will prevail at Appeal Court. Time though is not on our side as every day that goes by we are losing money..
Concur
Hi BB,
Thanks a lot for your great effort on behalf of investors. I really believe that you need to bring to the
attention of the Judge how the government is displaying their contempt for the Court despite the NCE ruling.
May I suggest that you first talk to the clerk as an investor asking what is the fastest way to bring this
to his attention? Once you get the clerk feedback you can proceed by certified mail quoting the name of the
Clerk and the time of your conversation. Best of luck to you and thanks again for diligently outing so much effort
In this never ending saga on behalf of all investors. Perhaps you can send JT a copy of your letter and request that his chief counsel follow up on this breach.Thanks
Kindest regards
The very last line of the majority decision of Us v Caronia is all the judge needs in ruling against fda that their actions are unlawful.
Absolutely not to-morrow!
No they are not expecting the "same response". Amarin is only expecting the same point of divergence. Epadel was given only at 1.8 gram to Post Menaupausal women in Japan while Vascepa was given at 4 grams to people in 11 eleven different countries including US . Do you expect the same response under these circumstances?
No, statistical data between Control and EPA diverges after one and a half year on drug after 4-5 years study in Jelis. Amarin is expecting similar divergence... That is why year 2016 is important!
Thanks. It is not important to be precise as 5% versus 5.2% does not mean much to me. Only the big picture matters as it helps to invest with increasing confidence. The difference between 5% and 5.2% would not sway my thoughts one way or other..
And the longer time it takes, the better it is to show how Vascepa is effective in reducing a first cardiovascular events. Control is assumed to produce no more than 5% cardiovascular events... Recall that officially Amarin only knows the TOTAL events.
Sir, where is no need to flatter me as I deserve much less. Idea is to provoke to see who can integrate it all and see what is around the corner. Of course I am still talking about Amarin. You can get the best response to your question by talking to a number of Mds who are in charge of clinical trials for their respective companies. Then you can arrive at your own conclusions to see what lies ahead around the corner...
Not yet "obvious to judge" as he is giving FDA more time...
Once REDUCED-IT endpoints are met, there will be a paradigm shift in lowering the incident of cardiovascular disease. It will be Statin + Zetia + EPA. Currently I take 20 mg of Zocor ( Lipitor increased my liver enzyme), 10 mg of Zetia and 4 gm of pure EPA (Vascepa). My LDL is 70, total cholesterol is 160, Triglyceride is 80. Prior to this with Statin and Zetia only, my Triglyceride was 200, LDL was 100. Note that I do not mention HDL (good cholesterol) since it is irrelevant.
No side effects whatsoever including arthralgia, non-inflammatory joint pain since I am on the minimum effective dose.
Just a matter of time before REDUCED-IT confirms that it is likely that FDA took bribes from those generic companies in turning down the Anchor SPA after all endpoints were met and after Amarin spent $100 m to do REDUCED-IT upon FDA's request!
From the amicus briefs we know big pharma inlcluding Pfizer is on our side in this battle.
They will stop only when RR is above 15%, p is less than .0001 and a certain Power of 90% etc. Please read Bi_watch two articles on Amarin so that you get a good background about this and then read the CC statement about Reduced-IT being positioned to succeed. On what basis? Think and integrate it all and you will have a reasonable answer that will increase your confidence ...
It is routine stuff if you know an MD who is working for a Company that has a drug in Clinical Trial. That MD talks to the MDS that are monitoring the safety issue. For example if a Company is giving a drug that is causing patients to go blind, the Company MD is immediately made aware of this fact. Then the Company MD passed this info to the Company which proactively informs FDA and make a determination to stop the study. Do you get the gist of it?
In their last CC JT has already said that they will start preparing
for a possible early peek in 2016 even though he qualified it that it is not the most likely event. BI-Watch has written two excellent articles in Seeking Alpha.
This is the norm for Clinical Trial. Companies watch very closely so that they do not waste money. Talk to folks who are involved in Clinical Trials. Usually the Doctors of the Company talked to the Doctors who are monitoring the side effects of the drugs. So the Company has an idea on a monthly basis how effective the drug is together with its safety profile. This is routine stuff.
Every month the Doctors in charge of Reduced-IT unblind the Control and Vascepa arms for safety reasons. Officially Amarin knows only the total number of events. Prior to start Amarin calculated that 968 events equal 60% of events for a first interim look. To date 93% of patients have been enrolled out of the total 8000. Unofficially Amarin have an idea based on Doctors monthly un-blinding of events which part are Control etc. If it was not going as projected they would have stopped the trial by now! If Amarin does not win the injunction from the District Court they are bound to win it at the Appeal Court (AC) since AC is bound to follow the law of precedence of US vs Caronia. Get some money ready and double down as soon as Amarin crashes further if District Court judge gives too much deference to FDA. Else Judge may give FDA all the opportunities to add disclaimer so that FDA will have no legs to appeal upon his Rulings...
Concur that the spinning has started. But cannot wait
for the preliminary injunction though... Fda is causing irreparable
harm to the public because it is not allowing the Doctors plaintiff to make the most intelligent decisions in off label prescribing since FDA is preventing them from receiving the information from the most knowledgeable source- the manufacturers!
It would be great if judge adds " substantial but not concrete evidence" on off label for Anchor. He has basically made up his mind...
which could be to give the Anchor label!
How would you interpret a "different" relief?
I am hoping the judge also reinstates Anchor as part of a "different relief" that Amarin seeks in its Complaint. Also Amarin spell out to the judge that the rescission of Anchor was "unlawful". That would be something!
The entire suits rests on the central Hudson tests. It is a 4-part tests that determine whether a commercial speech is protected by the First Amendment. It is as follows:
1. First speech must be non-misleading and concern lawful activity
2. To justify regulations restricting speech, the asserted government interests must be substantial.
3. Regulation must directly advance government interests in a material way
4.The regulation must be narrowly drawn.
As it is clear from the government briefs opposing preliminary injunction,it flunks the tests big time. Instead of explaining how releasing Anchor trial results to sophisticated doctors hurts its interests, its simply refers to its June 05 letter over and over...
The Complaint is based on threats of the Complete Response Letter and not on the June 05, letter. The June 05 letter adds insults to injury since it also piles up the threats! What a loser!
You are correct. The best argument in favor of Amarin is the inherent threat detailed in the Complete Response Letter about "misbranding" and civil and criminal liabilities as well as unilaterally rescinding the Congress approved SPA!
and from now onwards FDA will start to practice medicine as medical doctors
are no longer qualified to practice medicine!
Thanks for responding. The Amicus brief from the Washington legal Foundation correctly anticipates the FDA response and gave the judge all the legal arguments ( Central Hudson case, narrow tailoring, disclaimer etc..) he needs to issue a preliminary injunction. Since the FDA has no legal grounds it is attempting to turn this into a "regulatory issue" which the Court has no jurisdictions to rule over. Amarin aslo anticipated this as it clearly specifies in its Complaint that it does not want the Court to determine whether FDA was right or wrong in Anchor SPA rescission. The issue at hand is a first amendment violation by FDA since it bars Amarin to engage sophisticated doctors in completely truthful and non-misleading information about the results of the Anchor trial.
Fda does not have any legal arguments to oppose preliminary injunctions. It believes that suit is none-issue because it does not argue about misleading and non-truthful informations. It argues that Anchor label was not awarded because there will be no incentive for Amarin to complete Reduce-IT trial. Once again FDA over-steps its boundaries by ignoring Congress meaning of SPA agreement. FDA also believes that the second circuit precedence of Caronia does not apply here! A preliminary injunctive relief will come very fast after Amarin submits its Reply. Amarin will not have to use its additional 5 pages in its Reply.
Anyone knows whether judge also advances Amarin's Reply in his second order? Thanks
At some point in the current Complaint, Amarin informed the judge that the FDA was informed that the Anchor rescission was "unlawful" and later asked for a "different" relief. Does that open the door to include Anchor label as part of the relief?
why not file an amendment to current Complaint?
Do you think that Amarin will now make an Amendment to
state that they cannot be a dietary supplement since thay have
been granted the NCE which the FDA appended to their Regulatory letter without commenting on it?
Just because FDA grants Anchor, dispute does not need to end
because FDA does not dictates when dispute ends. Amarin can then file an Amendment and seeks punitive damages since irreparable harm has been committed to Amarin interests and its shareholders. The scope is narrowed only if Amarin does not file an Amendment and leave the original Complaint intact.