From reading Heartwire etc ...Adcom is expected because Anchor is such a large patient population.
Reduce it had to about 40% enrolled before AMRN could apply for the Anchor indication.
Re the discussion on wether to approve Anchor or not .
If you search thru the Lipid/Metabolic section of Heartwire ...lower right CME ( continuing med ed ) section you will find discussions with Dr Ballantyne ( Anchor Trial ) and Dr Nissen ( Chair of Cardiology at the Cleveland clinic )
They both agree that Outcome trials have to be underway before an indication like Anchor can be approved ...that is the key .. Outcome trial underway .
Dr Ballantynes view is that Vascepa is safe and effective so theres little down side in granting the Anchor indication since the the Reduce it Outcome trial is substatually underway . The only downside really is that if Reduce it fails to show benefit then you just wasted $ on expensive fish oil.
Dr Nissen's view is that since we are likely to have results from Reduce it end of 2015 - mid 2016 ( even the Jelis study did not run the full 5 yrs planned ) why not wait until there is proven clinical benefit.
Both Ballantyne and Nissen are considered "thought leaders " ...my money , literally , is on Ballantyne.
OT ---great yacht racing ( Americas Cup ) on the SF bay this weekend
Akanz ( also known as kiwi ! )
Akanz: An excellent post given a thumbs up! You have sussinctly summerized what I think is the reasoning behind the advisory meeting.
The fact that the patient population to be served is very large is an underlying reason, but not the critical reason. The FDA surely does not want to have healthcare to pay for Nissens unproven clinical benefit in advance. But: Its the two perspective you state later that drive this meeting. Ballantynes perspective versus Nissen perspective.
The meeting is going to pay lip service to the safety and efficacy results of ANCHOR. The real heavy discussion will be the Ballanytne perspective versus Nissen and it will get heavy. Whose perspective will win the day? This is why the total roster mak-up is critical and should be examined with a fine toothed comb before plowing your final money into this meeting!
You state that your money is with Ballantyne perspective.
AF obviosly is marketing that Nissen will win!
Me---I hope ballantyne wins, but I am not cocky enough to be so sure? Nissen route is the safe route "politically" and that is what scares me given the FDA healthy risk/political history therefore I will play it down the middle, take some profit into the meeting given a decent chance, take some shares into the meeting itself and hope Ballantyne wins. I admit this gambit can winsave me money or lose me money. In the end i don;t know who is going to win here!
Because in my mind if Nissen wins, then AMRN is stuck until 2016 unless they can negotiate an interim analysis to be added into Reduce-it, to reduce the time to a re-submission. A timepoint to examine the data pre 2016 which should have been in the protocol in the first place!
This all supports my cautiousness heading into the meeting---it could work out great, but its not a done deal! Everybody will believe what they will believe!
Does anyone know who the AdCom advisory members are going to be, or where I could get that information? I might like to study up a bit on their expertise and qualifications.
Thanks in advance.
sadie: they have a stable of rosterplayers in that therapeutic level they draw from----sure the roster is not finalized or published yet. Eventually we will find it within the FDA website as will we find the briefing documents a couple days before the meeting itself!
The roster finalization is likely being finalized as memeber must review the brifing documents long before you will get to see them. The good news is AMRN gets them long before the meeting as well---we are the ones left out until the end!
I was unable to locate the roster for the upcoming meeting in October, however, I located one from the last meeting in June 2013. As there are no vacancies for nominating new members for this committee, I suspect the list has not changed...a guess on my part.
ACTING DESIGNATED FEDERAL OFFICER (Non-Voting):
Minh Doan, PharmD
Division of Advisory Committee & Consultant Management
Office of Executive Programs, CDER, FDA
ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE
Erica H. Brittain, PhD
Biostatistics Research Branch
National Institute of Allergy and Infectious
National Institutes of Health (NIH)
Ellen W. Seely, MD
Professor of Medicine
Harvard Medical School
Division of Endocrinology, Diabetes and
Brigham and Women’s Hospital
David W. Cooke, MD
Clinical Director, Division of Pediatric
Director, Pediatric Endocrine Fellowship
Johns Hopkins University School of
Robert J. Smith, MD
Professor of Medicine (Endocrinology)
Alpert Medical School of Brown University
Ocean State Research Institute
Providence Veterans Administration Medical
William R. Hiatt, MD, FACP
Professor of Medicine
Division of Cardiology
University of Colorado School of Medicine
President, Colorado Prevention Center (CPC)
Ida L. Spruill, PhD, RN
Medical University of South Carolina
College of Nursing
Charles A. Stanley, MD
Professor of Pediatrics
Perelman School of Medicine
University of Pennsylvania
Division of Endocrinology & Diabetes
Children’s Hospital of Philadelphia
Abramson Research Center
Good luck with your DD and let us know what you dig up. TIA.
Dr Nissen? Adam Feuerstein corresponds with Dr Nissen and AF uses his responses to bash Vascepa. Dr Nissen's predecessor at the Cleveland Clinic was forced to quit for allegations of hedge fund stock manipulation. Dr Nissen was a subject of a recent whistleblower lawsuit for stock manipulation. All other known cardiologists predict Anchor will be approved by the FDA. Also Ballantyne didn't call Vascepa an expensive fish oil
Just so we all know: Cleveland Clinic predecessor, Dr. Topol, called out Merck about bad science but wasn't squeaky clean after having done some consulting for a VC group in Chicago. Merck countered punched so Topol forced out, Nissen comes in and steps on Merck's throat. Topol's punishment is to be in San Diego instead of Cleveland.
As to AF & Nissen,: Nissen is one of the Godfathers of the Cardio (mafia) Families. Of course, AF is going to talk with him then go off and write whatever he was going to anyway, using quotes to back up his POV. Sorta of what is done constantly in medicine. Science-based medicine???
WM ..correct Dr Ballantyne DID NOT call Vascepa expensive fish oil . Sorry if my writing implied that . He is very strongly in favor of everyone with any kind of CV issue or diabetes having access to Vascepa asap
ANCHOR is not REDUCE-IT though. It's it's own indication, and has important benefits on it's own outside of what REDUCE-IT provides. There is obviously a benefit. The ANCHOR trials showed that with the positive results. People have a need for it. The off label use in that indication range for Lovaza proves that.
I don't see why we need to know REDUCE-IT results before approving a separate indication. That would be like saying we can't get MARINE approved without REDUCE-IT. MARINE and ANCHOR each provide benefits in the range they target. The trials showed it. They also showed there are no safety concerns.
There really is no downside to approving ANCHOR on time.
Sentiment: Strong Buy
I think that is the best explanation posted yet! I like your comparison to MARINE. I think their is a lot of questions on why an ADCOM is needed and it has some people concerned, including me to a degree. Your post above and Frenzy's below should take about a 15 minute meeting, including the vote. lol SO WHY IS THERE AN ADCOM? The billion $ question!
Sentiment: Strong Buy
Hey Dallas, good points. There really is nothing that stops ANCHOR approval. Really. The SPA must meet the qualifications of safety, efficacy and 50% enrollment in REDUCE-IT by the time of the sNDA. IF AMRN fails one of these three things then the FDA has a reason to deny or delay ANCHOR. Vascepa has met the efficacy standards, even going well beyond what was asked for in the original agreement. AMRN had the necessary enrollment in REDUCE-IT on time. AND the one element that sticks a fork in just about every FDA approval, SAFETY, is Vascepa's strongest attribute; there simply isn't anything safer. So, why the Advisory Committee? Well, it's a first time drug into an indication and that almost immediately necessitates an ADCOMM. The endocrinologists looking at the data are going to be impressed with just about everything they see but will have to make sure there are no clinical problems. They can search far and wide and all they'll find is a resounding hallelujah from doctors and patients and the blood work. If they are concerned this will turn out like all previous statin add-ons, they have only to look at JELIS for relief and dozens of recent reports showing unbelievable ancillary benefits of pure EPA. If the FDA for whatever reason beyond the three I've described above decides to deny ANCHOR, then their word is no longer good and biotech's spending huge sums of money in R&D and running outcome trials to get a drug to market will come to a screeching halt. They don't want that, nobody does. ANCHOR is as certain as anything the FDA has EVER considered.
Sentiment: Strong Buy
I agree with you. Delaying ANCHOR until REDUCE-IT outcome could cause unnecessary life loss while approving ANCHOR now ahead of REDUCE-IT outcome could cause unnecessary monetary loss. I ask everyone on this message board what's more important? An extra few thousand dollars in the pocket or an extra few years in life span? I know what I'll choose and I think I know what AK would choose. FDA should just approve ANCHOR now and let patients and doctors make their own choice.
Dang it Ching... took the words right out of mouth. I'm gonna say I'm really anxious to try Vascepa for my overall wellness, plus my wife says I need some anger managment classes. I told her more nookie would do the trick. I have a really old joke... what do they call Jewish foreplay??..
Give up? A half hour of begging.....
Good points I agree .
I'm currently on Zetia ( Enzembie ? ) even tho we won't know if there is a clinical benefit until late 2014 ( Outcome trial ) .
When prescribing it my Cardiologist said that he believed it would show benefit , but we won't know,as i said , for at least a year , however if I wanted to pay for it ( $5 a day ) , he would prescribe it .
It was my choice .
Vascepa is safer then Zetia so if Zetia was approved while waiting for the Outcome data ...Vascepa should be also.
OT:Akanz I just noticed that your post defended fair speech on Ihub has also been deleted. Pretty soon atlus snugglepuss is going to have the whole board to himself if he continues to delete posts. Glad I never joined and just use the free version.
Re early data made public ....absolutely not . Dr Bhatt is running the trial . He is one of the most respected scientists in the field of Cardiology there is . There is way to much riding on this to allow any kind of early release
FYI ...The Jupiter trial using Crestor was stopped after about 2. 5 yrs because of overwhelming efficacy. However there was a lot of criticism leveled at the DMC ( data monitoring committee ) for doing that as others felt more knowledge would have been gained by letting the trial run longer .
Sorry Frenzy ,but even Dr Miller , who is on the steering committee for the Reduce it trial recently stated at a presentation at John Hopkins that results were ( time adjusted to date of his comments ) 1.5 to 2.5 yrs away.
So chances of it being halted "any day " are very slim IMHO
Swalchie ...my post supporting free speech on IHUB was deleted ??? wow
By the way ...I would expect there is some behind the scenes negotiating going on between Amarin and other parties re the launch of the Anchor indication ( if approved, which I think is likely )
Lovaza scrips are still holding fairly steady ( Niacin/Niaspan is declining ) ...which shows the power of Big Pharma and an entrenched marketing campaign maintaining their market despite a better product ( Vascepa ) now being avaliable.
Amarin is making steady progress but wether they could make it thru 2014 without another capital raise is questionable IMHO
Thanks for the post akanz. I sure hope anchor is in the bag. I like to point out that there is always a possibility that the FDA could want more from the reduce it trails and a delay although hopefully unlikely is possible. We will know soon enough and at least the anchor run up looks like its begun and 2 of my 4 blocks of shares are now in the green.