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Anyone who comes through, listen to this. http://www.petromanas.com/s/News_Releases.asp?ReportID=558976
Wow, stock ghost town. Hopefully anyone from 2010 got out of their position. I think there is real potential here. Shell must agree as well.
You have to watch QRE.V as well. The Over The Counter QREDF has some ghost trading from the market maker to keep the price inline with the primary Canadian QRE.V. They're not usually 100% lined up but neither is our two currencies. QRE.V has on average 4x more volume than QREDF does.
Stark do you follow QREDF or QRE.V?
I need to move to Belgium where there are no capital gains taxes. The stock market is my primary source of income.
Rubberworm, you live in NJ? North or South? I'm near Philadelphia. We could have a beer one day after Quantum takes off.
I'm thinking the same thing Six.
If this deal wasn't still on the share price wouldn't be propping itself up everyday.
It's probably Jody Dahrouge. Following his selling pattern lately it is usually on the 4th or 5th of the month. Now that he has been removed his selling wont show up as an insider trade. But I doubt his company made any kind of a turnaround and is supporting itself. I spoke with him on the phone for nearly 40 minutes back when he was selling in November. I don't have any reason to doubt that he is selling shares at a loss to make payroll for his core group of staff. It sucks that we suffer for his poor finances.
http://www.canadianinsider.com/node/7?menu_tickersearch=QRE+%7C+Quantum+Rare+Earth+Dvlpmt
Any shareholders out there that follow IamGold closely know who is handling your Niobium sales as of November? Since 2008 it was Claude Dufresne, founder of Camet Metallurgy, which was a IamGold JV. Last week it was announced Dufresne left and is working with Quantum Rare Earth Developments Corp http://www.quantumrareearth.com/press-releases/158--quantum-announces-changes-in-directors.html
I'm working on figuring out the circumstances of this move, I own stock in Quantum. I'm not sure if Dufresne left willingly or if IamGold decided it was his time to go. Also, if Camet is still handling the sales ect.
Interview with the CEO
http://www.equities.com/tv-updates?s=8PLSKSBP
I don't own this stock, but I watch it, just wanted to pass this on.
I think he is full time with BioAegis Therapeutics Inc. he's VP of Corporate Development and a founder. But he receives more than a full time salary from Lightwave. Wastefull spending like that should be frowned upon and I hope has been questioned by this potential partner.
ObamaCare to cover obesity drugs made by Arena, Vivus
http://sandiegobiotechnology.com/topics/5566/more-insurers-obamacare-to-cover-obesity-drugs-made-by-arena-vivus/
Probably better off with the link.
By Rex Graham
This season of pumpkin pie, mashed potatoes and rising obesity rates is a perfect time to talk turkey about the overly bearish sales estimates of Belviq and Qsymia, the obesity drugs approved by the FDA this summer.
The oft-cited $1 billion-a-year combined estimated sales for Qsymia, which is made by Vivus, Inc. (VVUS), and Belviq, made by Arena Pharmaceuticals (ARNA), should be revised upward. Why? It’s not just because of Aetna’s Nov. 20 revision to include Qsymia and Belviq “as medically necessary weight reduction medications” for its 37.3 million covered health plan members.
Two important 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 Qsymia and 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 Qsymia and 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. Consider this: the market capitalization of Vivus currently at $1.12 billion and Arena’s market cap at $2.03 billion. Even if the obesity drug market’s eventual size is one-tenth of the highest current estimate, both companies are grossly undervalued.
Obesity policy timeline
“The epidemic of obesity-associated diabetes is a major crisis in modern societies, in which food is plentiful and exercise is optional,” Mitchell A. Lazar, director of the Institute of Diabetes, Obesity, and Metabolism at the University of Pennsylvania, writes in Science magazine.
Image: Diabetes-body weight study in the U.K., BBC
This is the timeline of major events in the past 12 months that underlie the assessment that sales of Qsymia and Belviq will be better than expected:
• November 2011: A “decision memo” by 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. (Neither Qsymia norBelviq had been approved by the FDA yet.)
• May 8, 2012: A report by U.S. Institute of Medicine and the Robert Wood Johnson Foundation estimated that the annual cost of treating obesity-related chronic disease and disability is $190.2 billion. Obviously, reducing obesity reduces obesity-related costs and “the staggering human toll.”
• June 2, 2012: The U.S. Preventive Services Task Force recommends intensive, multicomponent behavioral intervention for patients with BMI of 30 or higher to reduce weight and lower metabolic risk factors for diabetes and cardiovascular disease. (Still no decision by the FDA at this point on Qsymia or Belviq.)
• June 27, 2012: FDA approves Arena Pharmaceutical’s Belviq, along with a reduced-calorie diet and exercise, for chronic weight management of adults with BMI of 30 or higher (or BMI of 27 or greater when the individual has a weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol). It was the FDA’s first approval of a weight loss drug in 13 years.
• July 17, 2012: FDA approves Vivus’ Qsymia along with a reduced-calorie diet and exercise, for chronic weight management of adults with BMI of 30 or higher (or BMI of 27 or greater when the individual has a weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol).
• November 20, 2012: Aetna, a health insurance provider to 37.3 million policyholders, revised its Clinical Policy Bulletin to include Belviq and Qsymia as “medically necessary weight reduction medications.” (Each Aetna benefit plan defines which services are covered; members need to consult with benefit representatives to determine if their plan has limitations that would apply to obesity medicines.)
ObamaCare to cover obesity drugs
“Along with Aetna, many other private insurers already cover visits and obesity counseling, and ObamaCare will mandate that preventative services for obesity are covered,” said Dr. Michael Kaplan, chief medical officer of The Center for Medical Weight Loss, a Tarrytown, N.Y.-based company with 750 affiliated doctors in weight loss clinics nationwide. “ObamaCare should lead to 100 percent of the population being covered for obesity management in 2014.”
Benefits of modest 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? Combining Qsymia and/or Belviq with a low-calorie diet, exercise, routine counseling and related approaches may actually work. Image: NIH
An estimated one-third of the total U.S. population of 311 million are obese, defined as having a body mass index (BMI) of 30 or higher, which is equivalent to a person who is 5 foot 4 weighing 175 pounds, or a person who is 6 foot 4 weighing 247 pounds. (BMI is defined as weight in kilograms divided by height in meters squared.)
A landmark 2005 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? Combining Qsymia and/or Belviq with a low-calorie diet, exercise, routine counseling and related approaches may actually work.
“Getting patients to lose even 10 percent of their body mass is huge because health outcomes improve dramatically even with modest weight loss,” says Dr. Michael Kaplan, chief medical officer of The Center for Medical Weight Loss, a Tarrytown, N.Y.-based company with 750 affiliated doctors in weight loss clinics nationwide. Photo: The Center for Medical Weight Loss
Kaplan is using that approach with Qsymia and “having pretty good results in combination with intensive counseling and behavior modification” with no side effects. “In some cases we can discontinue hypertension medications and medications for type 2 diabetes,” Kaplan said. “Getting patients to lose even 10 percent of their body mass is huge because health outcomes improve dramatically even with modest weight loss.”
Checking zero-sum math
Some analysts describe the market for Qsymia and Belviq as a zero-sum game, with sales of one hurting the other. It’s easy to understand the argument: with Qsymia costing $120 to $160 a month, mostly out of pocket, and Belviq expected to cost roughly the same, a patient will use only one or the other, right? It depends.
Indeed, about 30 percent of the patients who have received Qsymia prescriptions didn’t fill them. Dr. Edward Zbella, medical director of the Tampa, Fla.-based Medi-Weightloss Clinics, said his 82 affiliated weight loss clinics plan to use the two generic drugs in Qsymia at a price of about $40 per month of treatment, rather than relying on Qsymia, with a price tag of $120 to $160 a month.
“There is no advantage for us to use Qsymia,” Zbella said. At the same time, he 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 Qsymia and Belviq prescriptions, his clinics will prescribe them.
Qsymia capsules. Image: Vivus, Inc.
Belviq tablets. Image: Arena Pharmaceuticals
Patients who want to lose the most weight the fastest may opt for Qsymia. Why? Patients taking it in clinical trials lost 8.6 to 9.4 percent of their body weight (compared to controls) at one year. Weight loss with Belviq was 3.0 to 3.3 percent at one year. However, Belviq has a better safety profile, and may end up being more popular for maintaining weight loss long term. Neither drug can be used during pregnancy.
“Qsymia looks like a better drug for a patient who weighs more, so we may start a patient on it, but Qsymia and Belviq are both are excellent for maintaining weight loss,” Kaplan said.
Reasonable expectations
Vivus reported $453,000 in Qsymia shipments for the last two weeks of September, an amount equivalent to roughly only 3,000 prescriptions. The intentionally cumbersome online ordering from CVS Pharmacy and Walgreens hurt. The FDA required the difficult ordering process and home delivery of Qsymia as a way to limit sales to women of childbearing ages, but weight loss doctors say the FDA has gone too far if the federal government truly wants to lower the obesity rate.
“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.
Investors understandably don’t have the patience for such glitches to be resolved. Many pulled out of Vivus because of the disappointingly slow initial sales, but it’s time for them to come back to Vivus and Arena because the insurance landscape is shifting in favor of the two companies.
New Year’s weight-loss resolutions
Already, Vivus has expanded its online distribution network for Qsymia to two additional home-delivery networks: Express Scripts and Kaiser Permanente (for its 9 million health plan members). Some analysts now predict a substantial increase in Qsymia sales in the fourth quarter. They may be correct, but as anyone who frequents a fitness club knows, almost all new members arrive, like clockwork, in January, not the fourth quarter of the year.
“Right now, it’s slow at our clinic, which is usual this time of year,” Aronson said in a pre-Thanksgiving telephone interview. “In January, patients literally line up at the doors.”
The post-holiday bump in interest in weight loss is great timing for Belviq, which should be available by then. However, it must first be “scheduled” as a controlled drug by the U.S. Drug Enforcement Administration (DEA), after which Eisai, Inc., will begin marketing it in most of North and South America (including the U.S., Canada, Mexico and Brazil). Eisai has a marketing and supply agreement with Arena.
Red tape opportunity
It’s possible that the FDA could require the same unnecessarily cumbersome online prescription ordering process for Belviq that has slowed Qsymia sales. However, Kaplan said his weight loss clinics regard the red tape as an opportunity. Office staffers sit down with patients at a computer and assist them with ordering. Patients love it. Refills are much simpler and return visits are easier on everybody.
Since reimbursable counseling sessions are now recommended as an essential part of weight loss treatment, clinics have an incentive to schedule additional patient visits. More frequent visits help ensure that patients follow through on prescription ordering, adherence to diet and exercise plans and achievement of significant weight loss.
Post-marketing diet pill studies
The FDA has required both Arena and Vivus to conduct post-marketing studies, including long-term outcomes trials to assess the effect of Belviq and Qsymia on the risk for heart attack and stroke. Until the post-marketing studies verify cardiovascular safety, many physicians won’t get out their prescription pads.
“Physicians in our practice are unlikely to significantly prescribe either the phentermine/topiramate combination [Qsymia] or lorcaserin [Belviq] in the near future,” said Umesh Masharani, a clinical professor at the UC San Francisco Diabetes Center.
Masharani points to his experience with the then-almost-magical combination of fenfluramine and phentermine, known as fen-phen. A study published in 1984 in Archives of Internal Medicine found that after taking fen-phen for 24 weeks, overweight patients lost an average of 18.5 pounds, versus 9.7 pounds in the control group receiving only individualized diets.
After sales soared in the 1990s, fen-phen crashed following the publication of a 1996 paper in the New England Journal of Medicine by researchers at the Mayo Clinic. They reported a correlation between heart valve dysfunction and fen-phen.
Lingering fen-phen fears
Umesh Masharani, a clinical professor at the UC San Francisco Diabetes Center and author of “Diabetes Demystified,” says, “Physicians in our practice are unlikely to significantly prescribe either the phentermine/topiramate combination [Qsymia] or lorcaserin [Belviq] in the near future.” However, the FDA’s approval of the two obesity drugs recognized the obvious; the potential health gains of even modest weight loss, including cutting the rate of type 2 diabetes, far outweighed the potential risks of side effects. Photo: UCSF
Today, Masharani and other diabetes specialists are quick to point out that one of the ingredients that was present in fen-phen, phentermine, also is present in Qsymia (phentermine and topiramate in extended-release form).
Patients in clinical trials taking Qsymia lost 8.6 to 9.4 percent of their body weight (compared to controls) at one year. Weight loss with Belviq was 3.0 to 3.3 percent.
“We are concerned about the adverse reactions of these drugs and the relatively modest efficacy,” said Masharani, author of the book “Diabetes Demystified.”
Masharani’s diabetes patients will have to wait for post-marketing studies to be completed before receiving a prescription for Qsymia or Belviq.
The FDA weighed the risks of waiting to approve Qsymia and Belviq versus not waiting for further studies. It came to the opposite conclusion as Masharani. The regulatory agency’s approval of the two 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.
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You mean who will be COO?
I doubt Tom's going to give up the well paying gravy job he has as our CEO. But I hope that whoever we combine with has someone very SHARP that will become our COO and we can kick college dropout Marcelli to the curb. I would also like to see Cordavano replaced with someone more dedicated and affordable. The same goes any other staff that are currently not able to perform their duties.
I bolded the whole thing to make a point. Everything in that update is important. I see alot of future catalysts in there, and I like they're dedication to the shareholders interest (see the red text.) I have even more respect for the CEO now. He outline a concise plan for the next couple years and it's one that I am excited about. It seems his experience from prior companies is being put to very good use. This release gave the stock a nice little jump from around 2.60 to 2.90, but I see today we're back to the 2.70's. If you wish to ad shares do it in the near future, I highly doubt there will be a much lower entry point before we begin 2013.
Investor Update
I have bolded the most important parts.
28 November 2012
Dear Shareholder,
We started 2Q2012 with $16 million in cash, no debt, an expanded board of directors, a strengthened management team, continued strong growth in acceptance and uptake of ReCell® Spray-On Skin® amongst key surgeons, a growing body of published literature reporting excellent ReCell clinical results and a clear plan to establish Avita as a market leader in the emerging field of regenerative medicine.
We remain committed to building a sustainable and profitable business for the long-term; in the near-term we are maintaining our highly focussed, strategic approach to laying the foundation to support our growth. We continue to make excellent progress with solid achievements against each of the key components of our long-term strategic plan and have launched several key initiatives for the coming 12-24 months:
? Obtain reimbursement for ReCell in key markets
? Establish ReCell as a core tool in the management of chronic wounds
? Expand ReCell product line offerings to differentiate specific markets
? Obtain FDA clearance for ReCell sales and marketing in the US
? Increase shareholder value and visibility among potential institutional investors
CORPORATE ACTIVITIES
? Completed successful A$10 million capital raising
? Expanded Board with two new directors
? Strengthened management team
Capital raising. At the General Meeting in Melbourne, Australia on 19 October shareholders approved the A$10.36 million capital raising led by Octa Phillip Bioscience Managers and Australian Ethical Investment, $2.99 million of which came from existing shareholders via the Shareholder Purchase Plan (SPP). As at 1 November 2012, following disbursement of costs associated with the capital raising, the company had $16 million cash or in deposits on call.
Board expansion. On 22 October Avita Medical announced the board appointments of Mr Jeremy Curnock Cook and Mr Matt McNamara. Mr Curnock Cook has served on the boards of numerous international healthcare and biotechnology companies from his base in London and brings a wealth of experience to the board. Mr Curnock Cook was former head of the life science private equity team at Rothschild Asset Management, was responsible for the launch of the first dedicated biotechnology fund for the Australian market and the launch of a joint venture with Johnson & Johnson Development Corporation for the creation of Healthcare Ventures, an investment vehicle dedicated to seed stage investments in Europe, as well as the conception and launch of the International Biotechnology Trust (IBT).
Mr McNamara, currently Chief Investment Officer and Fund Manager of OctaPhillip Bioscience Managers, has extensive experience in the biotech sector, serving on numerous boards and having a decade of experience in sales and marketing and general management in the pharmaceutical sector with Merck & Co. and Johnson and Johnson Medical Pty. Ltd. respectively and was CEO of a Life Sciences Venture Capital fund, SciCapital Pty. Ltd.
Strengthened management team. The company continues to develop a world-class management team with two recent hires :
Ms Debra Leeves was appointed General Manager Europe, Middle East and North Africa (EMEA). Ms Leeves has an outstanding record in the healthcare and biotech sector. Previously, Ms Leeves was Marketing Manager EMEA for GE Healthcare and in various senior sales and marketing management roles with Pfizer/Wyeth and GlaxoSmithKline.
Mr Timothy Rooney was appointed Chief Operating Officer/Chief Financial Officer in October. Mr Rooney has 23 years' experience in senior finance and operations. Most recently he was CFO/COO of a large pharmaceutical wholesale business, which under his guidance grew from an early stage start-up to a US$450 million business.
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REIMBURSEMENT
? Initiated medico-economic studies in key markets to support reimbursement applications for ReCell
? Demonstrated large cost savings achievable to healthcare systems
A major business objective for Avita is the obtainment of coding and reimbursement for ReCell in core markets including the United Kingdom, Germany, France, China and the US.
In the current climate of imposed austerity, health care costs are under increasing scrutiny as governments and health-payer systems seek cost curbing opportunities. Reimbursement processes for medical technology are complex and vary from country to country with the responsible agencies serving as gatekeepers to the inclusion of medical products as accepted standards of care. The major European
markets and China have implemented new systems for reimbursement coding, closely regulating payment for medical technology.
Anecdotal evidence for cost saving is no longer sufficient. Controlled economic studies are required to support cost savings claims for reimbursement. Avita has commenced studies to provide direct evidence for ReCell cost benefit claims. Avita has engaged expert reimbursement consultants to
develop cogent strategies to expedite the application and
approval process and is working closely with a select group of influential surgeons at select clinical centres to conduct country-specific medico-economic studies to support application for reimbursement.
Economic data documenting cost savings achievable with ReCell in burns treatment have been collected at Pinderfields Hospital in the UK and were presented at the recent International Society for Burn Injuries in Sept 2012. The data demonstrate the significant savings available to the healthcare system with incorporation of ReCell into the management of burns.
CLINICAL DEVELOPMENT
Data comparing the cost of treatment burn patients by size of burn, up to discharge using ReCell vs current standard of care. Data based on recorded expenses in treatment of 26 burns patients at Pinderfields Hospital Burns Units United Kingdom during 2011. Economic models indicate significant economic benefits obtained using ReCell in management of acute burn injuries, even in relatively small burns (<10% TBSA) which represent the majority of burn injuries.
? Clinical studies underway to further expand and support marketing claims
? Promising preliminary results with ReCell in management of chronic wounds
? Initiating controlled study in treatment of venous leg ulcers
? Progressing FDA trials with additional US$880K support from US Department of Defense
Clinical studies Avita continues to work with selected surgeons at leading centres throughout Europe in conducting small-scale, in-market studies on a variety of indications, including treatment of burns, acne scarring, scar revision, vitiligo and rejuvenation procedures (e.g., wrinkle removal), representing a subset of potential applications for ReCell. Results of these studies have been and will be presented at scientific medical conferences and published in peer-reviewed medical journals and will support clinical efficacy claims in applications for reimbursement.
Lower limb ulcers Lower limb ulcers (LLUs), which include venous leg ulcers and diabetic foot ulcers, are a major healthcare problem in developed countries due to their prevalence, high cost of treatment and detrimental impact on patient quality of life. LLUs afflict nearly 1.5% of the general population in OECD countries and up to 3% over the age of 70 years. The expense of treating LLUs imposes a major financial burden on healthcare systems. In the US alone some 6.5 million people suffer from LLUs with associated annual treatment costs estimated in excess of US$25 billion; similar prevalence and expenses are documented for the UK, Germany and France. The costs to patients include associated morbidity, pain, lack of mobility and lost work days and wages.
3
In preliminary open-label studies, ReCell was used at four European centres to treat approximately 80 patients suffering from venous leg ulcers and diabetic foot ulcers. The average
age of patients' across study centres was approximately 70 years; wounds were open an average of approximately 13 months and averaged approximately 21 cm2 in size.
Results of these preliminary studies have been encouraging. Over 70% of patients showed complete healing of the wound within 7-12 weeks following a single treatment with ReCell. With the current standard of care treatment it would be expected that approximately 43% of these wounds would have achieved closure during this period. ReCell appears to yield a highly significant positive effect on wound healing. Pain, a critical indicator of quality of life, was reported as significantly reduced or eliminated within 72 hours following ReCell treatment.
Given the positive results achieved in preliminary studies, Avita has
initiated a randomised control study with leading clinicians at up to 5
European centres. Up to 80 patients will be enrolled in the study.
Study protocols have been submitted for approval by the relevant ethics review boards at each centre. It is anticipated that enrolment in the study will commence during the 1st quarter of 2013.
Healing of chronic lower limb ulcers in one
participating study centre. 95% of ulcers achieved closure of 80% or better within 60 days following a single treatment with ReCell. Data provided by B. De Angelis et al., Tor Vergata University, Rome, Italy.
US FDA trials. The US remains the largest single market in the world for medical products. We will continue to pursue FDA approvals for ReCell to access the US market for a range of clinical indications.
Avita was recently awarded an additional US$880K from the US Department of Defense Armed Forces Institution for Regenerative Medicine (AFIRM), supplementing the $1.75 million in previous funding in support for Avita's on-going US FDA trial for the use of ReCell® Spray-On-Skin® in the treatment of burn injuries. The US FDA burns trial comparing the performance of ReCell against split-thickness grafts, the current standard of care, is progressing with seven investigational sites in the US actively enrolling patients.
The FDA-approved study is complex and highly conservative in design and inclusion criteria; hence enrolment has been slower than hoped. Approximately 80% of the required subjects have been enrolled in the study and are undergoing follow up.
The award demonstrates the commitment by the US Department of Defence, the US Army, and AFIRM to bringing the ReCell technology through the FDA approval process and cleared for sales in the US, thereby making it available for the military and civilian population.
SALES AND MARKETING
? Continuing focussed marketing approach, working closely with select influential surgeons
? Growing list of publications and presentations by prominent clinicians and Centres of Excellence
? Clinical demonstration studies in China continuing with >150 procedures conducted in support of pricing application
Avita continues to expand sales and marketing presence in key European markets, participating in regional and international congresses, sponsoring targeted clinical studies and supporting our direct sales representatives, joint- venture partners and distributors in advertising and marketing.
Avita is continuing its strategy of focussing on a few high-value markets and within those markets working closely with a limited number of key surgeons and clinical sites. This 'deep versus broad' approach is yielding positive results as we continue to build a core group of ReCell users and establish a strong clinical foundation.
Our goal over the next two years is to achieve wide scale penetration and usage of ReCell, establishing ReCell as standard care for a range of indications including the treatment of chronic wounds, acute burn injuries and aesthetic procedures. To maximize this outcome Avita is pursuing reimbursement for ReCell in specific countries and developing the next generation ReCell products to meet needs of various markets.
4
EMEA. Consistent with Avita's strategic approach we have engaged a select group of highly regarded and influential surgeons with whom we are working closely. These Key Opinion
Leaders (KOLs) are assisting in the establishment of best practises in the use of ReCell, demonstrating the substantial benefits of ReCell in treating a range of indications, presenting clinical outcomes at national and international congresses and publishing their results in peer-reviewed journals.
The growing adoption of ReCell and the value of closely engaging KOLs is evidenced by the nine presentations on the use of ReCell delivered at the 16th Congress of the International Society for Burn Injuries (ISBI), Edinburgh, Scotland in September 2012. Presentations covered
a range of topics including: use of ReCell in the treatment of paediatric
burns and scalds, as a replacement for grafts in burns, in the modification of scars, in combination with split-thickness grafts, in the treatment of facial burns and an economic cost-benefit model for use of ReCell. These presentations represent work done at key international Centres of Excellence including hospitals in the United Kingdom, Italy, France, Australia and the United States. It should be noted that there were no presentations on ReCell at the 2008 ISBI Congress, a single ReCell presentation at the 2010 ISBI and this year nine presentations.
Presentation by Mr Benjamin Way Consultant, Chelsea and Westminster Hospital, London, UK, on the use of ReCell in treatment of burns to the face delivered at the ISBI conference in Scotland September 2012. Mrs Isabel Jones, Consultant, Burns and Plastic Surgery Chelsea and Westminster Hospital Foundation Trust is shown performing a ReCell procedure in which two ReCell kits were used to treat a significant burn to the face and
China. Avita is progressing its entry into the large Chinese market. We recently signed with a Chinese distributor and hired a Territory Manager, based in Beijing, ensuring that Avita has a direct presence in the market. The company is pursuing the same focussed strategy in China as in the EMEA
countries, working closely with a small, select group of influential
surgeons to ensure excellent outcomes, and establish a base of core users and Centres of Excellence.
In conjunction with our Chinese distributor, Avita recently participated in the Chinese Society of Burns Annual Academic Meeting held in Zhengzhou in October 2012. This is the major meeting of burns surgeons in China with over 500 surgeons in attendance. Presentations included use of ReCell in the treatment of superficial to full thickness burns and the use of ReCell in the
Mr Jeremy Rawlins, presenting data collected while at Pinderfields Hospital, UK at the Chinese Society of Burns Annual Academic Meeting held in Zhengzhou, China in October. Mr Rawlins recently relocated to Royal Perth Hospital in Perth, Australia.
management of paediatric scalds.
Avita is finalising clinical studies at key hospital centres in major provinces in China. Over 150 patients have been treated with ReCell at Chinese hospitals to date. These studies are providing evidence on the clinical efficacy of ReCell in a range of indications
and will be used to market and promote ReCell. Additionally, endorsement by senior hospital officials is being used to support the submission of pricing applications for reimbursement necessary for the large-scale commencement of commercial sales of ReCell in China.
PRODUCT DEVELOPMENT
ReCell addresses the needs of a wide range of indications representing diverse markets each having distinct requirements. The company has initiated a project to develop and launch the next generation of ReCell products addressing the specific needs of the various market segments.
This is a major product development initiative by the company and the first significant development project the company has undertaken since development of the original ReCell device. The new products will significantly broaden our addressable market base, provide differentiation of product to address needs of different markets, and allow implementation of a range of business models and pricing flexibility reflecting the need of specific markets.
5
OUTLOOK
Avita Medical has entered the next stage in the company's evolution. Avita is in its strongest ever position. Avita is implementing key initiatives and making continued steady progress against the Company's strategic plan. We are developing our base of KOLs, expanding our geographic reach, addressing new fields of use for our flagship ReCell product and advancing the development of the next generation of regenerative products.
ReCell is becoming integral to the treatment of acute and chronic wounds, plastic and reconstructive surgeries and a range of aesthetics procedures.
We do not underestimate the challenges faced in the introduction of highly innovative and disruptive new technologies such as ReCell in the current global economic conditions. We are, however, confident that we will continue to accomplish our strategic goals, achieve sustainable growth and profitability, and establish Avita as a market leader in the emerging field of regenerative medicine.
Management feel strongly that the recent share price does not reflect the company's stage of development or recent progress made by Avita. In the coming months we will be working with potential institutional investors to increase Avita's visibility in financial markets and build shareholder value.
On behalf of the Avita Medical Board of Directors I thank our shareholders and employees for your loyalty, support and dedication. I am honoured to have you with us in this fascinating and exciting endeavour and look forward to providing updates on Avita's progress in the coming months.
Please feel free to contact me with any questions or for additional information.
Yours faithfully
William F Dolphin PhD Chief Executive Officer wdolphin@avitamedical.com
The Company has three offices of operation: United States (Northridge, California) focussed on management of regulatory affairs, clinical trials worldwide and operations; United Kingdom (Cambridge) focussed ReCell sales & marketing for the EMEA regions; and Australia (Perth, Western Australia) focussed on sales of respiratory products and market entry into Asia Pacific.
AVITA MEDICAL LIMITED
ASX: AVH OTCQX:AVMXY
AVITA MEDICAL OFFICE LOCATIONS
ASIA PACIFIC
Suite G01
68 So. Terrance
South Perth WA 6151
Australia
+61 (0)8 9474 7738
Info.au@avitamedical.com
EUROPEAN HEAD OFFICE
1st Floor, Unex House
132-134 Hills Road Cambridge CB2 8PA United Kingdom
+44 (0)1223 341 150 info.eu@avitamedical.com
AMERICAS
Suite 220
9221 Corbin Ave
Northridge CA 91324
United States
+1 818 356 9400
Info.am@avitamedical.com
Sticky the petition? Just a suggestion.
Jake's just lowering his cost basis.
IR did pass my questions on to someone higher up in the company, but the response from them was to refer to the post on Facebook.
Decent volume and price today. Maybe the news about Claude spread around to people who work in the industry.
When he said that I thought he meant financing via another company that wants to develope the resource.
I know they weren't completely out of money before the private placement so they should be ok for a while.
I have issues with that article, it's poorly written and misleading.
I shouldn't get worked up because in the end it only matters if they sign a contract. In the past 2 weeks we found out the CEO bought 400,000 shares and the guy responsible for selling all of IAmGold's Niobium has come to work for Quantum. I'd wager that those 2 people think something will good will happen. Otherwise Dufresne wouldn't burn his bridges with IamGold and Dickie could have easily waited until after a deal is signed and bought shares @ .20 cents through his options, but he chose not too.
As for that article, let's see where to start.
"officials believe more than 100 tons of the element are lying more than 500 feet below agricultural land about 70 miles southwest of Lincoln."
100 tons? haha, closer to 100 million tons. The updated resource estimate Indicated Mineral Resource of 19.3 million tonnes grading at 67% purity and 83.3 million tonnes at 63%.
Next,
"Colorado-based Molycorp abandoned an Elk Creek niobium mine in the 1990s because it didn't appear that a mine could be profitable, but niobium prices have increased since then."
Molycorp abandoned all projects at this time, not because it wouldn't be profitable but because they required full resources focused on developing Mountain Pass, which is still their primary mine today. And yes, the price of Niobium has increased like the article said, but it didn't mention how it's price has increased 8X since then.
"Everybody sees it as a longshot," Gottula said.
Yes, nothing like an arbitrary viewpoint of some guy in Nebraska to sum the quality of this article up, I'm sure he has the inside track on what's going on in office in Canada.
"It would cost between $300 million and $400 million to create a Nebraska niobium mine that might employ as many as 500 people, Dickie has said."
This was also in the article
"The U.S. Geologic Survey estimates $400 million worth of niobium was imported in 2011, up from about $330 million the year before. Niobium hasn't been produced in the United States in significant amounts since the 1950s."
So if I'm reading this right any company with the $ can spend 300-400 million to be the only producer of a product that sells 400 million a year in this country alone. Not to mention the product sold is steadily increasing in value, and if they themselves require it for their products they'll be getting it at cost and able to increase profits in all their products that require Niobium? Does this not sound like a pretty smart business move?
We need that petition on 4chan. They get shit done over there. http://www.huffingtonpost.com/mobileweb/2012/11/29/4chan-kim-jong-un-time-person-of-year_n_2212571.html
I think it violates SEC rules if a company contacts investment outlets looking for exposure that would increase the share price. Much like how they could not post on this message board.
It's a lack of real exposure that is the problem. The only people seeing news about Quantum are the shareholders who are eagerly looking for it. This isn't being written about by Seeking Alpha or Motley Fool and definitely not any big news outlets. But eventually we will be recognized one way or another. Remember when Quantum was mentioned on Fox Business News and it went it to .70 cents? Assuming they get a partnership nailed down, I hope that it's with a public company that people are familiar with. That news will get noticed then because it won't be just Quantums news anymore, it'll be X company's news. The share price will go up considerably because of the new investors it will attract.
I agree that Quantum is a gold mine. And we can buy shares at .12 cents. It seems to good to be true, but there are stocks sprinkled out there with this much tangible potential. Sometimes you're lucky enough to find one. I'm sure random investors have overlooked this, but keep in mind many don't have the ability to recognize value. I see a great deal of value in this stock.
He's the CTO.
If he showed up at the shareholders meeting you and I would both "know" who he is. He's a name to me. They should make Dave Eaton the CTO.
Straight from the Lightwave homepage.
Dr. Louis Glasgow: Chief Technology Officer
Dr. Glasgow joined Lightwave Logic as CTO in November 2011. He completed a postdoctoral fellowship at the Radiation Chemistry section of the Max Planck Kohlenforschung Institute in Germany and taught at Northeastern University in Boston before joining the DuPont Company in 1973. At DuPont, Dr Glasgow held a series of positions in research, manufacturing and administration. His last position was Director of Research.
Dr. Glasgow worked for Corning as the Director of Research, Organic Technologies from 2003 through 2010, along with Dr. Joseph Miller. There he directed work aimed at improved ceramic catalyst substrates for automotive and truck emission control, organic coatings for glass and plastic relevant to the company’s interests in fiber optic communications, life sciences, and display technologies. In addition, he directed work aimed at creating novel organic semiconductors for display and photovoltaic applications.
Dr. Glasgow received a B.S. in chemistry from the University of Illinois, and M.S. and Ph.D. degrees in physical chemistry from the University of Wisconsin at Madison. He is a member of the American Chemical Society, Sigma Xi, and the American Association for the Advancement of Science (AAAS). He was appointed a fellow of the AAAS in 1995.
I wouldn't, if you hit the jackpot she'll know.
I don't own enough to get wrapped up in any hype. All the negative attention ARNA was getting about Wall Street shorting this illegally I expected a volatility cool off. Also, shouldn't we be nearing the end of most institutional accumulation? That should help to. As far as the share price, I don't have any opinion on how low it will go, only on how high.
You have a small typo, 100,000 shares.
I bought another 10k today, I couldn't believe it didn't jump up today. I'm at the point now where I don't know if it's stupid of me to buy more or not buy more. The events in the last week are making me think it's the latter.
American Elements Announces 2nd Annual Top Five "Endangered Elements" That Will Gravely Affect US Manufacturing
List of Most Threatened Metals on the Periodic Table Signal Danger for U.S. Industry
By American Elements
Published: Thursday, Nov. 29, 2012 - 6:13 am
LOS ANGELES, Nov. 29, 2012 -- /PRNewswire/ -- There will be no more "Made in the USA," with millions of jobs lost if the United States doesn't start mining and stock piling certain strategic metals, according to Alisha A. Ahern, co-director of the Academics & Periodicals Department at American Elements, the global chemical and metals manufacturer which published the list. Today the company released its annual top five Endangered Elements List (EEL) of metals that can upset American Industry.
American Elements funds preparation of an annual EEL to help manufacturers, the government and consumers better understand the gravity of the situation. Twenty-first century metals such as copper, iron, nickel and tin have given way to critical metals, particularly the rare earths of which the US mines almost none.
"Today China mines a whopping 97 percent of all global rare earth production. America no longer has the resources to manufacture the things we invent," says Ahern. "Advanced metals like Niobium and Yttrium have become essential to thousands of household goods including computers, cell phones and cars. If we lose access or run out of these elements, there will be no more 'made in the USA.' "
According to American Elements CEO Michael Silver, this list goes to America's fundamental ability to generate prosperity, create jobs, defend itself and compete in the global economy. He adds, "Innovation is in fact only the starting point. To manufacture the products flowing from great ideas, a nation must also have access to the critical materials on which the discoveries are based."
The 2012 Endangered Elements List (EEL) describes this year's top five metals that can affect America's success in the 21st century.
2012 ENDANGERED ELEMENTS LIST
#5 NIOBIUM
Niobium is an essential ingredient in structural steel. It increases steel's strength and toughness. It is also used extensively in the super alloys from which jet engines are produced making it critical to the U.S. military and aerospace industries. Yet at present a single nation produces virtually all of the world's niobium. That nation is Brazil which last year produced 58,000 of the 63,000 total tons produced worldwide. Should Brazil suddenly discontinue niobium exports due to worker strikes, for political reasons or other events, it would have an immediate dramatic impact on global steel production. At present the U.S. produces no niobium importing 100% of its annual consumption in spite of the fact that one of the world's largest proven niobium deposits is located in Nebraska (Elk Creek Mine owned by Quantum Rare Earth Development Corp.)
#4 ANTIMONY
All car batteries, commonly referred to as lead-acid batteries, contain antimony to improve their charging ability. And this accounts for less than 20% of antimony's uses. In the form of antimony oxide, it is an essential ingredient in flame retardants required for fire protection. For the U.S. auto industry to compete with other newly emerging national auto industries, such as China's, America will require a ready access to antimony. Yet America produces no antimony and 90% of the world's antimony production comes only from China.
#3 STRONTIUM
Most only know strontium due to Strontium 90, an isotope of the element that is produced in nuclear fission reactions and is therefore a major component in the nuclear fallout from an atomic bomb blast. However, few know that strontium in the form of strontium nitrate is the propellant that causes air bags in cars to open. It is also heavily used in ceramic and glass production. Yet again the U.S. is 100% reliant on foreign producers, with 2 countries- China and Spain- controlling most of its production.
#2 PLATINUM
If you look at a periodic table you might note that all the metals found in a jewelry store are touching each other in a little island in the center. Gold, silver, platinum and palladium form a class of metals we commonly call the "precious metals" because unlike most other metals they always remain shiny and lustrous. However, they also share other even more significant properties for industry and science. They constitute the catalysts which run much of our modern industrial world. Look hard enough in the catalytic converter on your family car and you will find platinum, gold and/or palladium. We can make neither food nor energy without these precious metal catalysts. And these metals have far greater pressure on their availability and cost than other metals which derive their value based solely on their industrial importance. Precious metals have the additional demand pressure that comes from their inherent monetary value. Emerging nations such as India are consuming record volumes of gold simply for investment or decorative purposes. Yet, for example, the U.S. produces almost none of its platinum consumption. Nearly all of the world's platinum production coming from one country—South Africa—and much of the balance from Russia. The two countries combined account for 86% of world production. The heavy future demand for precious metals, particularly platinum, as catalysts in industry and as safe havens of choice for emerging wealth will put significant pressure on their availability in the future.
#1 YTTRIUM
The number of state of the art technologies that require yttrium are too many to list here. The toughest hardest commercial ceramic material known to man is made with yttrium (YSZ). YSZ can be found in hundreds of important applications from gas turbine blades to dental crowns. Like many advanced elements, when combined with other elements yttrium has numerous wholly unrelated magical properties that form the basis for future billion dollar industries. It is ionically conductive as YSZ which makes it the electrolyte in fuel cells. It is superconducting as yttrium-barium-copper oxide. Combined with aluminum or iron it forms a garnet that is the crystal in most commercial and medical lasers. Yttrium is in all automobile spark plugs. Access to yttrium will determine which nations will compete in manufacturing many of the innovations of the 21st Century. Yttrium is the last of a group of 17 metals at the very bottom of the periodic table known collectively as the lanthanide series or "rare earths." Each of the rare earth metals has its own unique set of properties that are critical to some future trillion dollar industry. #1 and #2 on last year's EEL were also rare earths (lanthanum and neodymium). Today China mines 97% of all global rare earth production. America presently produces from only one rare earth mine, the recently re-opened Molycorp mine in Mountain Pass, California which was closed in the 1990s. Other U.S. rare earth mines, such as the Ucore mine at Bokan Mountain, Alaska are years from approval unless the federal government and environmentalists can find a way to expedite the approval process.
American Elements is the world's manufacturer of engineered & advanced materials with corporate offices and primary research & laboratory facilities in the United States and manufacturing & warehousing in the United States, China, Mexico and the United Kingdom. www.americanelements.com
SOURCE American Elements
Read more here: http://www.sacbee.com/2012/11/29/5018283/american-elements-announces-2nd.html#storylink=cpy
http://www.sacbee.com/2012/11/29/5018283/american-elements-announces-2nd.html
A good safe move. I sent that article and statement to someone in IR at Vocus that I've built a rappor with. I asked for a response from someone farther up who works closely with PRWeb.
I liked that Vocus didn't apologize for this, they provide the outlet for these publications only. It is not their problem to verify the truth of the news.
I always thought Lightwave could have something that Corning would be interested in. Before I knew alot about Lightwave I thought that was why Joe Miller got on the BOD.
That brings me to a login page, can you sign out and repost the link?
We're almost at twice the daily volume but no upward movement. That is disappointing to me, the day isn't over yet though.
I signed it. That petition needs to hit some weight loss message boards.
This is awesome!!! I didn't win the Powerball but this makes up for that.
"Mr. Dufresne started Camet Metallurgy Inc., which was responsible for the worldwide Sales and Marketing of Iamgold's niobium until the end of October 2012. Mr Dufresne is a member of the Ordre des Ingenieurs du Quebec, and of the Tantalum & Niobium International Study Center (TIC)."
So Dufresne is the one who sells all of Iamgold's Niobium and he comes to Quantum? The Rolodex of companies who he sold to must be a mile long. And remember those business relationships are HIS not Iamgolds.
I hope the stock reacts appropriately tomorrow.
He doesn't need them.
The answer I got was that he owns 1,020,000 shares. And does not receive salary in the form of shares.
Thanks Buzz, interesting. I'm pulling the engine out of a 57 Thunderbird today and have no computer access. Hopefully some news is coming.
30k 1.24? Every time I get into LWLG on my ETrade app it forces closed.
I'll email IR and ask. I may have sent the same email 7 months ago or I read it on a different message board. I think he gets a decent chunk of his salary paid in shares.