Through all of this between AMRN and the FDA and the media and MB's we are forgetting one big ridiculous FACT..
This is all over a Very Effective, pure and SAFE (no side effect) Omega-3, and a company Amarin that has jumped through every hoop and obstacle put in front of them by the FDA..
Yes I state again a SAFE, and EFFECTIVE Omega-3... Not a cancer drug, liver drug, brain treatment etc..
Meanwhile every week we see ANOTHER drug with EXTREME Toxic side effects, and/or killing People, walking through ADCOM Panels with flying colors and then receiving FDA approval to boot.
Yup that's right, for the first time in the History of the FDA and drug's a SPA was rescinded after hitting every guideline for what is most likely one of the safest, if not the safest drugs on the market. And drugs that are killing people walk through without a bump in the road.. Makes ya think...
I have never been one for conspiracies, but something bigger and way beyond all of our pay grades is what is taking place here.. This isn't about AMRN or the drug and those who hang on will most likely be rewarded very well. But it's just crazy to think that this is all happening over a SAFE, PURE and EFFECTIVE Omega-3..
Everything else at this stage being guessed or posted by both bashers and pumpers and of course our friends in the media (you know who u are) is just wasting time and breath. Everything will fall into place, it's just about whether your around in the near term to see it all come together..
Continued good luck to all going forward.. On both ends..
Contrary to what many shorts believed, the FDA is taking the decision to reinstate the ANCHOR SPA very seriously. If the decision was already made not to reinstate the ANCHOR SPA as the shorts have contended, this would have been announced today without any further delay. This would have been an easy decision.
However, it now appears that the FDA is ready to reinstate the SPA and negotiating with Amarin regarding the the ANCHOR sNDA approval; and in what form that will take place. Most likely, ANCHOR sNDA will come with some restriction (whether boxed warning or regular warning) cautioning about the lack of cardiac outcome study and possibly conditional approval linked to REDUCE-IT outcome results.
If they were not close to a final compromise, the delay in the FDA decision would most likely have been announced earlier in the week- not at the last moment. To this point, PR stated "based on dialogue with DMEP, Amarin does not expect the delay to be for a significant period of time." Any way, I see the delay as a very positive development.
IMV, the FDA would not have delayed the decision twice if they did not intend to reinstate the ANCHOR SPA and approve the sNDA- it appears that there will be a compromise that would best serve the patients with high TG levels and address FDA concern. I believe the final approval will come with either a warning regarding lack of cardiac outcome data, conditional approval linked to REDUCE-IT data, or limited approval to a sub-population of high TG patients with low HDL. The approval is likely to come sooner than later.
I wanted to wish all the longs who have suffered greatly through this debacle the very best tomorrow. You all deserve much better than what has happened so far.
I also wanted to thank the all the people, including doctors, patients, investors, and concerned citizens who took this fight to the FDA to right the wrong perpetuated by the reviewing division. In particular, the dedication and efforts of the members and supporters of EPA drug Initiative have been amazing. They have dedicated much of their time to right this wrong.
Based on the efforts of EPA Drug Initiative, the Citizen Petition, the involvement of key congressional leaders, I believe that the FDA will get it right this time and reinstate the SPA. They simply had no scientific justification to rescind the SPA and the FDA would lose all credibility to do otherwise.
Please note that the Citizen Petition has been accepted by the FDA and posted for comments.
Contrary to some misinformation being propagated, the citizen petition has been accepted and posted on the FDA website. Go to regulations.gov and search FDA-2013-p-1612. The petition is now open for comments. It is an excellent document- factual and to the point.
Thanks to EPA Drug Initiatives and its members for their outstanding work on this document and submitting this crucial document.
The commissioner and the reviewing division have also received the CP.
Here are the results after taking 4 grams of Vascepa:
total cholesterol before 177, now 143
Ldl before 81, now 70
Triglyceride 205, now 122
total c before 195, now 163
Ldl before 95, now 84
Triglyceride before 156 , now 87
we believe those improvements with Vascepa are stellar. Any questions?
This is just the start of the short squeeze.
There are many compelling reasons as to why the FDA will reinstate the ANCHOR SPA. Contrary to what has been written, the FDA would not have put the ANCHOR SPA back into play if they did not intent to reinstate the SPA. FDA made a mistake in rescinding the SPA and realizing that they made this mistake, they will reinstate the SPA.
The risk of shorting AMRN into this binary event is much great than the potential benefit; the maximum upside gain is $1 while the potential loss could be $5-15 or greater. The down-side risk of this binary event just does not favor shorting at this price.
There are other important possibilities that have been rumored; the buyout is likely to happen in the near future with or without ANCHOR SPA and it has been rumored that AZN is positioning itself for a buyout to extend the patent on Crestor.
There is also an article in Pharmalot by a highly respected bio-tech journalist Ed Silverman who wrote that ANCHOR sNDA approval with "black box warning that a reduction in cardiovascular events was not a goal or proven in the Anchor study and that physicians must be cautious about prescribing the pill to patients with triglycerides below 500 mg/dl" was in the works.
Social Media and the fact that they are wrong. 10-20 years ago the FDA could have probably pulled this #$%$ and got away with it because nobody would have heard much about it. Now we have an entire website dedicated to fight the FDA! This EPADI is sending out Press Releases calling out the actions of the FDA and listing names. There is no way at this point Dr. Hamburg is not aware of what is going on with this SPA recession. I am sure they are trying to figure out how to save face on this. I honestly don't believe it will take 300 days to get a final decision on this SPA/Anchor. I think we will hear something much sooner as the pressure mounts. Yes, Amarin is a small company but they have the backing of the World Wide Web, and that is pretty powerful!
If the FDA was not corrupt, we would not be in this position. I sincerely hope that Thero is the type that will fight and not bend over to the FDA. From the research performed by people on this and the iHub board, it appears that there is quite a bit of solid evidence that FDA's Hamburg has family ties to GSK through her husbands investing and people on the Adcom board had ties to GSK as well. One would hopefully assume that Amarin's lawyers know this as well.
Renaissance Technology Holdings public report as of September 30, 2013: they held 3.891 million shares of GlaxoSmithKline – up almost a million from previous year.
Another outrageous item on their holding’s report is that Novo Nordisk is their second largest holding. That’s interesting because the Industry Member (non-voting) of the Vascepa ADCOM was Mads Rasmussen, PhD. of Novo Nordisk, diabetes research division.
Renaissance also has major holdings of Eli Lily, Calgene, Johnson and Johnson, and Astra Zeneca.
It is no wonder there are so many stories in the press about how hopelessly corrupt the FDA is and how beholden it is to Big Pharma. But when the Commissioner’s own husband (who makes an 8 figure salary) is a hedge fund manager in a company that specializes in investing or shorting, the drug industry, it is a conflict of interest so obvious, it is a wonder more hasn’t been made of it. (Read on the Schein case, if you are unfamiliar with Dr. Hamburg’s activity her first several months in the job in 2009. Since she has never sued for libel, I am going to assume it is all true.) Bottom line, is that there is a strong perception that ethics violations are occurring.
Write your congressperson, write the FDA, notify the press. If you want little comapnies like Amarin to win, sometimes you have to take matters into you own hands.
sts66 Thursday, 12/26/13 10:35:31 AM
Post # of 23110
From one of the brighter posters on the IV board, excellent summary of the position the FDA is now in:
The FDA lawyer's dilemma
As we all know, the rule of law governs in these parts.
A SPA is a binding agreement. Like all agreements, there may be defenses that vitiate enforceability (some may be statutory). This doesn't alter general principles.
In this case the defense goes to a scientific assumption upon which the SPA was based - meaning, the FDA needs to claim it would not have agreed to the SPA but for an erroneous scientific assumption which has since become apparent.
The right to cancel a SPA on a whim or unfettered discretion will not be claimed by the FDA. This would imply fraud in granting SPAs, because SPAs are used to raise funds, budget for R&D, secure investment, etc. The FDA is aware when it enters a SPA that doing so without intent to be bound in contract or to perform in good faith would potentially lead to harm.
Likely the awareness of this led to the Adcom exercise to obtain expert opinion to vitiate consent.
The FDA's attorneys might have been satisfied to defend the rescission on the basis of the (CYA) 9-2 vote.
But things have developed since then - and that's part of what's great about our system.
Dr. Ma (I assume) published an in depth analysis of the 3 post-SPA studies (that the briefing documents and Adcom relied on) and pointed out something strange. Breaking down groups into their relevant component parts not only failed to support the FDA and Adcom's position, but these studies actually support the opposite position - the original, and long held assumption upon which the SPA was based, that reducing Trigs in the Anchor population is likely to positively affect CV outcomes. [Note: Dr. Ma also submitted one of the CPs including the above material]
Very embarrassing, especially for highly paid experts flown from across the nation to sit on th
Further education tab, First from the top , NEW research reccomending TG's lowering as means to reduce CVD risk in patients with Low HDL and/or High TG's and Average LDL concentrations. YMB keeps deleting any other detailed reference I make to this research or any abstracts i try to publish (!!!!!!????), but pls go and read the conclusions
Sentiment: Strong Buy
TRx 6449 v 5201 up 19%. NRx 2443 v 1935 up 26%. Lovaza TRX 86687 v 72627 up 19% NRx28745 v 23715 up 20%. Comparisons odd compared to prior week due to prior week covering the holiday so don't read anything in to the increase. need to compare to last "normal" week
Please go to the FDA site where the petitions are posted:
Pick a petition or two or five and make INTELLIGENT and level-headed comments (that you agree, other points that you want to make, other things that you would like to see etc)
View the videos posted on the EPA site.
Spread the word regarding both of the above.
As specifically requested in the Citizen Petition, PDUFA date has been delayed and "Amarin's request to re-instate the ANCHOR Special Protocol Assessment (SPA) agreement remains under consideration with the FDA". No new PDUFA date was established.
As expected, no rejection at all.
To me, the most impressive in the PR is no mention of binding ANCHOR approval and REDUCE-IT completion. In fact, "t(T)he FDA also communicated to Amarin that it now views Amarin's appeal of the ANCHOR SPA agreement rescission and the ANCHOR sNDA as separate administrative decisions worthy of separate consideration. FDA plans to complete its review of Amarin's request to re-instate the ANCHOR SPA agreement and plans to convey its decision to Amarin no later than January 15, 2014. The FDA provided no additional information on when it expects to complete its review of the ANCHOR sNDA. " However, the correlation of the two is much stronger than the separation: a restated SPA guarantees an immediate approval of ANCHOR sNDA. Therefore, the January 15 is the "semi-PDUFA" date: if the SPA been restated, then a Class I (2 months for labeling adjustment) follows.
I have reviewed the very interesting material posted on the epadruginitiative site. First of all I would like to thank you for the big effort of putting the material together and the enornous due diligence done.
I gave my small contribution by signing the petition a few weeks ago, and I am more and more convinced that there might be sufficient elements to start a criminal investigation against the FDA or some specific members, and this regardless of the outcome of the ANCHOR SPA reinstatement and/or VASCEPA approval for wider use. Whilst it might be prudent to wait for a possible overturn of ANCHOR SPA rescission, I believe that if there was any wrongdoing (it is difficult to imagine that all those alleged data manipulation, misinterpretation and deceitful representation are simply due to genuine mistakes), this should be rightfully investigated and prosecuted, if applicable. Your thoughts are welcome.
The FDA decision to rescind the ANCHOR SPA is simply not supported by the evidence cited by the reviewing division. The reviewing division made a serious error in extrapolating that the lack of clinical benefit by fenofibrates and niacin therapy in patients with mostly normal and borderline TG levels somehow demonstrates that Vascepa would not have clinical benefit in patients with high TG levels, the ANCHOR population. In direct contradiction to the FDA reviewing division’s assertion, the sub-group analyses from these trials indicated that patients with high TG and low HDL had a remarkable reduction in CVD events of 28 % (ACCORD-Lipid), 37 % (AIM-HIGH), and 53 % (JELIS), clearly supporting a therapeutic benefit in ANCHOR sub-population.
We urge you to intervene in this important matter and take actions to overturn the reviewing division’s decision to rescind the ANCHOR SPA. For unclear reasons, the FDA reviewing division is going to great lengths to deny Vascepa for lowering TG in patients with high TG levels and mixed dyslipidemia, even if it means that they have to rely on flawed analysis. We respectfully request that the FDA make this important drug available without undue delay. We admire your integrity and your outstanding track record of compassion and dedication to improving medical care to the underserved, we remain very hopeful that you will investigate this matter fully and fairly, and conclude that the reviewing division erred in its review and that the decision to rescind the ANCHOR SPA was unjust.
Sentiment: Strong Buy