CombiMatrix Corporation Message Board

Nice thread, thanks for posting.

Dr, Dan, The EMA had me very nervous as time went on, and I went with my gut feeling. With that said, I couldn't resist nibbling my way back in after the withdrawal of the EU application. I looked at this as a potential positive as soon as heard the news. I know their are a few longs who disagree but this is my take. Arena pulled the application before they got the hammer. Why would Arena do this? Arena feels like there is a new way to approach approval, and recently said they are exploring new avenues, and the best way forward.

I wasn't sure at first and was guessing just like everyone else as to why they pulled it. I was waiting on the next bit of news to clarify the situation.

Arena obviously got wind of something that the EMA was concerned about. Arena could have addressed the issues and hoped for the best, or do just what they did and pull the application. Arena thought wiser and decided with the benefits outweighing the risk, they would approach it with a new strategy, diabetes first weight loss second. I now believe more then ever that Arena will get approval one way or the other. Good luck Doctor and as always I look forward to your informative posts! I can honestly say that you, and a hand full of others, helped me stay focused on the big picture. I am now in it for the long haul and hope we make a small fortune.

A letter dated 16 May 2013 has been sent from the International Bureau in Europe granting Arena a shorter time frame to review a proprietary document related to Belviq except with one VERY IMPORTANT DIFFERENCE:

Diabetes treatment (first), weight loss (second, subsequently)

Spinning Belviq, it would appear that the proverbial 'cart and horse' have been reversed!!! i.e. weight and diabetes... in this document, now diabetes and weight...

You should go to WIPO to find this key document just mailed out 16 May 2013

Sentiment: Strong Buy

Just to add: Richard DiMarchi has distinguished himself in pharmaceutical, academic, and biotechnology circles of scientific investigation. The majority of his career has been conducted while a scientist and executive at Lilly Research Laboratories

DiMarchi research group has discovered a set of incretin peptides that demonstrate unprecedented activity in pre-clinical in vivo models of diabetes and obesity. The central elements to success has been the chemistry to install within single peptides simultaneous agonism at related G-protein coupled receptors, and the counter-intuitive discovery that glucagon and GIP agonism could synergize the proven efficacy of GLP-1 in the treatment of the metabolic syndrome. A set of drug candidates differing in biochemical character have been pharmacologically assessed in rodents and primate disease models. They are independently being advanced clinically by three separate pharmaceutical companies.

Dr. Apovian is the director of the Nutrition and Weight Management Center and codirector of the Nutrition and Metabolic Support Service at Boston University Medical Center. She also serves as director of Clinical Research at the Obesity Research Center of the medical center and is an associate professor of Medicine and Pediatrics at Boston University School of Medicine. Dr. Apovian is a principal investigator for the Centers for Obesity Research and Education (C.O.R.E.) in New England and has been an active member of the Boston Obesity Research Nutrition Center (BORNC) for more than three years.
Dr. Apovian's ongoing research interests include novel medical treatments for obesity, type 2 diabetes monitoring

Steven R Smith is an internationally-renowned researcher who focuses on obesity, diabetes and the metabolic origins of cardiovascular disease. He was recently appointed as the executive director of Florida Hospital and Burnham Institute's Translational Research Institute for Metabolism and Diabetes in Orlando, Fla.

Sentiment: Strong Buy

That's what you were all screaming at $10

Sentiment: Strong Buy

Eisia PR release: Eisia is hoping to reach 600,000 patience with Belviq in the United States alone.

My math maybe a little off but not by much
600,000 X $200.00 X 12 = $1.2 Billion dollars Yr X 37% = roughly $600,000,000 Yr
Multiple 10X (conservative) = roughly $6 Billion market cap for Arena

Plus
$134M on first $250M sales
$1.2B in milestones from sales
$500 Thousand in Milestones X 3

And catalyst I pointed out in previous post.

Sentiment: Strong Buy

Just remove the blinders. You are in fantasy land!

Facts & highly probable catalyst

1. Arena will receive $134M on the first $250M in sales.
2. Arena will pay little if any taxes.
3. Arena will collect on 1.2B in milestones
4. Arena will announce a partner for ADP811 (speculation) in the third or fourth quarter.
5. Arena will gain EU approval on a revised application for Diabetes first, weight loss second.
6. Estimates look to low, Belviq will be a blockbuster
7. BP is interested and anyone who says their not needs to remove their blinders.
8. Belviq will gain approval in Switzerland, Mexico, Canada and around the globe.

Sentiment: Strong Buy

If what some are saying is true, Arena will re-apply Locacsrien / Belviq as a diabetes drug first weight loss second making the benefits outweighing the risk, I did hear Robert say during the presentation that Arena is actively exploring other opportunities for Lorcaserin / Belviq.

Sentiment: Strong Buy

Typical short distorting the facts.

We must be moving up today. Who hired you this morning?

Mr No Common Sense: News flash FDA has already approved and it will be on 20,000 pharmacy shelves in 3 weeks!

Only 15 days to cover shorty unless you want to go completely broke. I have heard of people jumping off bridges in your situation.

Sentiment: Strong Buy

Just keeps getting better and better!

Sentiment: Strong Buy

That's the talk and would make perfect sense why the application was pulled. They have obviously found something that leads them to believe this is the best strategy going forward.

Sounds good, did you see this:

A landmark study found that 27 percent of all national health care charges were associated with patients who are physically inactive, overweight and obese. More recent studies document that modest weight loss of 5 to 10 percent can significantly reduce rates of type 2 diabetes, hypertension, cardiovascular disease and other health problems. All private and public health insurance plans pay for diabetes drugs, and it’s only logical to cover obesity-prevention services and drugs that reduce rates of diabetes.

In other words, reducing obesity will save the nation some unknown percentage of the $190.2 billion it currently spends on obesity-related diseases ((such as diabetes)) and disability. At the same time, not all obesity treatments are cost effective: the National Weight Registry found that surgeries designed to restrict overeating don’t really work in most cases; most of those patients exercise very little, eat more high-fat foods than the norm, and gain the weight back.

Less costly approaches than surgery seem to work better. However, neither reduced-calorie diets alone, nor increased exercise alone lead to long-term weight loss. The combination of diet and exercise helps about 20 percent of people lose weight and keep it off, according to the National Weight Registry. What will help the remaining 80 percent? Belviq plus a low-calorie diet, exercise, routine counseling and related approaches actually work.
Zbella said a high-intensity approach of a low-calorie diet, regular exercise, counseling and weight loss drugs can be highly effective. “Type 2 diabetes is almost always due to obesity,” he said. “And older obese patients need hip and knee replacements, which are expected to increase ten-fold in the next five years, and the negative health impacts of obesity go on, and on, and on.”

However, if insurance plans are eager to avoid spending increases to treat type 2 diabetes, hypertension and cardiovascular disease, why not cover obesity drugs? Zbella said if health insurance providers cover Belviq prescriptions, his clinics will prescribe them.
Also noted: Qysima “It’s all kinds of paperwork; it’s a hassle and CVS and Walgreens don’t even stock them,” said Dr. Arthur Aronson, owner of Medarts Medical Weight Loss Specialists in San Diego, Calif. He sees up to 300 patients during a busy month, but refuses to prescribe Qsymia because of the prescription hassles – unless patients ask for it.
The FDA weighed the risks of waiting to approve Belviq versus not waiting for further studies. The regulatory agency’s approval of obesity drugs recognized the obvious; the potential health gains of even modest weight loss far outweighed the potential risks of side effects. The nation’s private and public health insurance industries have come to the same conclusion.

Credit to StockVadar: A letter dated 16 May 2013 has been sent from the International Bureau in Europe granting Arena a shorter time frame to review a proprietary document related to Belviq except with one VERY IMPORTANT DIFFERENCE:

Diabetes treatment (first), weight loss (second, subsequently)

Spinning Belviq, it would appear that the proverbial 'cart and horse' have been reversed!!! i.e. weight and diabetes... in this document, now diabetes and weight...

You should go to WIPO to find this key document just mailed out 16 May 2013

I wonder if Arena is evaluating Belviq and this new approach to other parts of the World. Seems like it would make sense with the evolving news surrounding diabetes and the benefits Belviq has shown. I would think this would have BP more interested into exploring Arena more now then ever. The market for diabetes is more valuable, not saying Belviq isn't valuable, both markets are worth Billions! I like where they are going with this. I did hear Robert say last night during the presentation that Arena is actively exploring other opportunities for Lorcaserin/Belviq.

Sentiment: Strong Buy

Usually however not in this case see you at $15

@Bill Policy shifts at the federal level – by the Centers for Medicare & Medicaid Services and the U.S. Preventive Services Task Force – also bode well for much broader coverage of weight loss prescription medicines. The shift is a logical way to cut massive health costs caused by obesity. The trajectory of policy shifts is leading experts to predict that Belviq will soon become covered by all private and public health insurers, including Medicare, the federal health plan for Americans aged 65 and older and younger people with disabilities, and Medicaid, the federal-state health program for low-income individuals and families.

Even the Mayo Clinic informs patients visiting its website that Belviq are “prescription weight-loss medications your doctor may prescribe.” Estimates of the market in the U.S. alone for obesity drugs are as high as $60 billion a year, but nobody knows for sure.

Obesity policy timeline
This is the timeline of major events in the past 12 months that underlie the assessment that sales of Belviq will be better than expected:
November 2011: the Centers for Medicare & Medicaid Services ((CMS)) states: “The evidence is adequate to conclude that intensive behavioral therapy for obesity, defined as a body mass index of 30 or higher is reasonable and necessary for the prevention or early detection of illness or disability.” More intensive treatment plans, including up to 26 office visits in one year, are now expected to become part of Medicare and Medicaid coverage