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Synopsys Inc. Message Board

lakers_w 489 posts  |  Last Activity: Dec 15, 2014 10:13 PM Member since: Jun 13, 2000
  • lakers_w lakers_w Dec 15, 2014 8:42 PM Flag

    From my experience, GS is positioning itself for an opportunity to upgrade MNKD shoud the launch is successful as Piper Jaffrey thinks.

    Piper Jaffray Joshua Schimmer's '15 Top 15 potential "Surprise" Biopharma Events: #7 SNY/MNKD Afrezza launch goes well.

    1. Gene therapy establishes proof of concept in hemophilia
    2. Heart failure explodes on the biopharma scene with gene therapy success
    3. Biopharma does even better in 2015 than it did in 2014
    4. Failed trials get approved, starting with BMRN's drisapersen
    5. BLUE cures sickle cell anemia
    6. BIIB finishes the year with the best large-cap pipeline and freedom to operate on
    Tecfidera
    7. SNY/MNKD Afrezza launch goes well
    8. PD1 antibodies start to look like a thing of the past
    9. AMGN blocks REGN/SNY's PCSK9 antibody
    10. A biosimilar Soliris enters Phase 3
    11. Gene therapy cures blindness
    12. Iran gets the nuke; military spending hikes force other budget cuts
    13. Two large-cap biotechs get acquired
    14. CBD hits the radar screen for autism
    15. ProQR transforms the CF landscape

  • December 15, 2014 10:19 AM EST
    streetinsiderDOTcom/Analyst+Comments/MannKind+(MNKD)%3A+Sanofi+Management+Continues+Support+for+Afrezza%3B+Goldman+Sachs+Maintains+Neutral+Rating/10096557.html

    Goldman Sachs maintained a Neutral rating on MannKind (NASDAQ: MNKD) with a price target of $6. Analyst Jay Olson said Sanofi (NYSE: SNY) management meeting shows continued support for Afrezza.

    "Sanofi Chairman and interim CEO, Serge Weinberg, has been meeting with investors to address concerns in the wake of leadership changes. Our London Analyst who covers Sanofi, Steve Chesney, met with Mr. Weinberg and came away with a positive message regarding the company’s commitment to Afrezza as an important component of Sanofi’s diabetes portfolio. Recall Sanofi guided to flat to slight growth for its diabetes franchise out to 2018. We note that pricing pressures referenced as a headwind for Sanofi’s outlook on the diabetes market have been discussed in the context of basal insulin, although we suspect those same pressures are likely apply to rapid acting insulins as well," said Olson.

    "Within its diabetes guidance, management highlighted optimism for the launch of Afrezza. In our analyst’s recent meeting, Mr. Weinberg continued to express enthusiasm for the commercial potential of Afrezza. With regard to the ongoing CEO search, Mr. Weinberg reinforced the company’s plan to pursue a candidate with international pharma experience including a particular emphasis on the US market, which is critical to the launch of Afrezza in our view," continued the analyst.

    "We are encouraged by Mr. Weinberg’s continued support of Afrezza and we believe Sanofi should maintain a steady course of action in diabetes based on the recent discussion. However, as detailed in our 10/19 initiation note, we believe MNKD is facing low profitability and delayed profits based on a slow ramp of Afrezza, patient-driven market dynamics requiring heavy SG&A spending and challenging deal terms with Sanofi," he added

  • Medtronic's China Ambitions

    Ten years ago, Medtronic’s sales in China amounted to $50 million. Today, the company will sell more than $900 million across China during 2014. The strategy Medtronic has embraced to achieve this stunning amount of growth has been multi-faceted: exporting innovative products from the US to China, establishing a R&D facility in China to design products specifically for the unique needs of the Chinese market, crafting partnerships with government to educate patients around under-served therapeutic areas, and acquiring domestic Chinese medical device manufacturers such as Medtronic’s 2012 purchase of Kanghui Medical for $816 million. Taken together, Medtronic’s China ambitions point towards a company confident in their ability to navigate one of the most complex and turbulent healthcare economies in the world.

    The last two years have introduced some turbulence to foreign device manufacturers working in China. Earlier this year, China’s National Health and Planning Commission (NHPC) put in place a new policy that said it would “pursue policies explicitly designed to favor domestic manufacturers over foreign manufacturers.” Since the summer of 2013, when the GSK scandal broke, the device community has kept a watchful eye on whether a similar crackdown would take place within the device space.

    Thus far, beyond a survey initiated during the summer of 2013 by the China Association for Medical Devices Industry (CAMDI), this has not transpired. Because device sales within hospitals do not appear to be vulnerable to the same sort of economic-rent seeking behavior by doctors and hospital administrators as pharmaceuticals have been, it is likely any issues device foreign device companies will face are likely to involve anti-monopoly (price fixing) questions versus the particularly toxic bribery allegations the pharmaceutical sector has been forced to work through.

    In the midst of these uncertainties, device manufacturers can take great solace in a handful of undeniable facts, each of which is a reason to remain positive about the opportunity in China. First, China’s demographics mean demand for cardiovascular, cerebrovascular, and orthopedic goods is going to explode. The numbers may be familiar to some readers, but they bear repeating here: by 2050, one-third of all China’s population will be 65 or older. Beijing already has over 1.7 million people living within the city who are 65 or older; Shanghai has over 2.3 million. This aging population means that by 2015, China will be the world’s second largest orthopedic market. The country has upwards of 350 million people who are active smokers, and the combination of tainted air, food and water all point towards significant demand for surgical procedures specific to cancer, heart disease and, thanks to the Chinese appetite for western food, growing rates of obesity and diabetes.

    Second, device companies working in China know that the Chinese government is rapidly moving to expand reimbursement for procedures that use foreign manufactured devices. Huang Wei, Medtronic’s Director of Channel Management for all of China, recently shared with me that “government reimbursement is crucial to Medtronic’s future successes, particularly in disease states such as diabetes.” The move to get basic healthcare insurance coverage to greater than 95% of the Chinese populace was the first step in this direction. Discussions underway between industry groups, business and the Chinese government all suggest that coverage for additional services is likely to continue, an important trigger for overall market demand of devices, diagnostics and pharmaceuticals.

    Third, regardless of the intrigue that has characterized the Chinese pharmaceutical market for the last two years, the fact remains that China’s government understands it needs strong partnerships with pharma and device manufacturers in order to deal with the onslaught of healthcare needs that will grow in China over the next several decades. However, the onus is on the private sector to make sure a viable and sustainable partnership exists between the Chinese government and business. During interviews for this column, Medtronic’s spokesman pointed to one specific partnership the company believes is the sort that will allow the needs of patients, the government as payer, and business to all work together productively: the 3-year partnership Medtronic has had with the Ministry of Health and the NHFPC. The partnership will focus on the optimization of care both in and outside the hospital for Type-1 diabetes, as well as the role insulin pumps may play in delivery of care. To make sure that the economic and clinical value of therapies is understood by physicians, patients and government officials, Medtronic is partnering with the National Institute of Hospital Administration, a think tank linked to the NHFPC, to carry out a series of research projects focused on building an integrated care pathway for people in China with Type 1 diabetes.

    This sort of care pathway has become an accepted way to evaluate treatment protocols that may utilize more expensive therapies and products in the short-term, but have proven their ability to lower overall costs long-term if these pathways are maintained. This sort of total-cost approach for specific population health management may be new to China, but it will be extremely important if the government is to bend the cost curve down in ways that ensure foreign medical device and pharmaceutical companies view the China market positively.

    The project, which is supported by the China Ministry of Health, will engage a panel of expert Chinese endocrinologists as advisors and include pilots at roughly a dozen regional hospitals of various sizes across China. The goal is to gather insight that will support a Chinese nationwide system leveraging Medtronic’s expertise to improve treatment of Type 1 diabetes patients and reduce the likelihood of costly complications. This sort of public-private partnership may be new in China, but it is an important way to educate everyone on the potential benefits of technologies and therapies whose value may require a longer-term view.

    It may seem all but certain that a company such as Medtronic has every reason to be confident in its ability to be successful in China; however, there are challenges beyond those touched on earlier. Distribution partnerships remain critical in China, and these relationships are rife with compliance risks. China’s highly fragmented pharmaceutical and medical device distribution network relies on thousands of dealers.

    Medtronic has over 700 independent distributors in China alone. Many distributors have an intermediary – commonly referred to as a dealer – who acts as the interface between the distributor and the hospital’s purchasing agent. The further away from the manufacturer the product gets, the more difficult it can be to ensure compliant sales behaviors are taking place. In a market like China where extraordinary growth also means strained government budgets to pay for newly demanded medical services, political pressures to identify non-compliant behavior and tie that back to a larger entity are always a concern.

    In addition, a company like Medtronic is coming to terms with how quickly Chinese medical device manufacturers have proven themselves capable of building medical devices that, if not as of today world-class, are definitely on-par with the needs of the domestic Chinese market. Why is this? One possible explanation for not only how quickly Chinese device makers have been able to close the gap between their best-in-class and the offerings from western device manufacturers is that medical devices (unlike pharmaceuticals) do not rely on intensive R&D and bench science. Medical device designs and manufacturing are inherently mechanical, reliant on processes, which are familiar to the Chinese manufacturing world. As complicated as they may be, medical device manufacturing is driven by injection molding, plastic extrusion, specialty metal treatment and fabrication, and assembly methods that Chinese manufacturers have proven themselves world-class in for complex electronics, to name just one analog industry.

    What could handicap a company like Medtronic’s Chinese ambitions? Certainly un-friendly government policies that favor domestic manufacturers over foreign-owned companies. Absolutely reimbursement policies that stagnate and never speak for more of the patient’s out of pocket expenditures. But one of the easiest to overlook ways that Medtronic’s China ambitions could struggle would be to see domestic manufacturers close the gap between the best-in-class product offering from Medtronic and what the domestic owned companies are capable of producing.

    This recognition in no small way illuminates the reasoning behind Medtronic’s various acquisitions within the Chinese device sector, but it also shows the ways in which Chinese companies are winnowing down the competitive advantages that established western businesses have long assumed would be their best protection and ultimate competitive advantage. Today, the pressure to innovate and allow frugal engineering to drive costs down for medical devices is creating a new standard of excellence that western device companies will have to embrace if they are to be successful in China over the next decade.

  • lakers_w lakers_w Dec 15, 2014 2:27 PM Flag

    Piper Jaffray Joshua Schimmer's '15 Top 15 potential "Surprise" Biopharma Events: SNY/MNKD Afrezza launch goes well.

    Another interesting potential "Surprise" event in the sector, according to Schimmer, is that two large cap biotechs gets acquired. "The number of large-cap ( $10B) biotech companies which offer attractive long-term growth opportunities to meaningfully inflect EPS trajectories for large pharma companies continues to grow," the analyst commented. "The list now includes BIIB, CELG, BMRN, PCYC, VRTX, ALXN, REGN and INCY. All could be appealing M&A targets and fit needs of larger pharma partners. While many investors may agree that one would be a boon for an industry, two of these could lead to a broader sector revalidation."

    Yet another potential "Surprise", is that MannKind and Sanofi Afrezza launch goes well.

    Below is a list of Schimmer's Top 15 Potential "Surprise" Biopharma Events For 2015:

    1. Gene therapy establishes proof of concept in hemophilia
    2. Heart failure explodes on the biopharma scene with gene therapy success
    3. Biopharma does even better in 2015 than it did in 2014
    4. Failed trials get approved, starting with BMRN's drisapersen
    5. BLUE cures sickle cell anemia
    6. BIIB finishes the year with the best large-cap pipeline and freedom to operate on
    Tecfidera
    7. SNY/MNKD Afrezza launch goes well
    8. PD1 antibodies start to look like a thing of the past
    9. AMGN blocks REGN/SNY's PCSK9 antibody
    10. A biosimilar Soliris enters Phase 3
    11. Gene therapy cures blindness
    12. Iran gets the nuke; military spending hikes force other budget cuts
    13. Two large-cap biotechs get acquired
    14. CBD hits the radar screen for autism
    15. ProQR transforms the CF landscape

  • lakers_w lakers_w Dec 14, 2014 1:20 PM Flag

    The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation. In the approval, Afrezza was asked to print a boxed warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Regarding hypoglycemia, in all 3 active comparator-controlled trials of this drug, subjects had overall 20-65% less hypoglycemia, and based on an A1C stratification analysis, it turned out that the decreased hypoglycemia occurred irrespective of subjects’ A1C levels.

    The 2 most interesting trends in my opinion were the decreased postprandial excursions that were demonstrated with 7-point glucose curves and the decreased incidence of hypoglycemia in the trials where comparator insulin was used and in the placebo-controlled trials, the event rate for subjects on metformin plus sulfonylurea was the same as metformin plus TI. Although TI had PK/PD advantages compared to insulin aspart, these 2 benefits were not statistically significant. The early onset of action of Afrezza compared to insulin aspart likely helped control the postprandial rise in glucose and the early disappearance of Afrezza compared to insulin aspart likely led to less late postprandial hypoglycemia after a meal has been absorbed (Figure 1). This type of data would support the position that a valid effectiveness endpoint could be a reduction in such type of hypoglycemic events if a novel insulin or insulin delivery system is associated with ultra rapid absorption. At the same time, an ultra rapidly acting insulin like Afrezza might be expected to produce less hyperglycemia immediately after a meal and less hypoglycemia late after a meal and result in little decline in the A1C. Such a drug could still be helping not only to mitigate glycemic lows and highs, but to also decrease glycemic variability (GV), even though GV has not been proven to be a true problem requiring treatment.

    Figure 1.
    Figure 1.
    Seven-point glucose profile at week 52 in T2DM subjects in a trial of Technosphere Insulin vs insulin comparator. Red square and red line = TI with each meal plus basal glargine insulin once daily. Purple circle and purple line = 70/30 insulin twice daily. This figure was adapted from data provided by Dr Anders Boss from a study by MannKind.

    The risk of lung cancer has been raised as a safety concern to the use of inhaled insulin. In the registration trials 2 heavy smokers developed lung cancer—1 while in a controlled comparative clinical trial and 1 while in an extension. This incidence of lung cancer (0.8 cases per 1000 patient-years) was felt by the company to be within the range of lung cancer observed in the general population (approximately 0.23-1.22 cases per 1000 patient-years, according to the American Lung Association). These incidences with Afrezza can be compared to the incidence of primary lung cancer and the mortality of primary lung cancer which were observed in a follow-up study of users of Exubera, another type of inhaled insulin that was available from September 2006 through October 2007. Comparing Exubera to comparator agents according to person-years of use, the relative increased lung cancer incidence and mortality with Exubera were 3.75 and 2.81 respectively and FDA classified pulmonary malignancies as adverse events of special interest for inhaled insulins. At the Afrezza panel hearing on April 1, 2014, the FDA reviewers raised the issue of whether inhaled insulin causes preexisting lung cancers to grow more quickly than they would otherwise grow, but neither FDA nor MannKind officials could think of a good way to prove or disprove that hypothesis.

    The FDA is requiring the following postmarketing studies for Afrezza:

    a clinical trial to evaluate pharmacokinetics, safety, and efficacy in pediatric patients

    a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function)

    2 pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, 1 to characterize dose response and 1 to characterize within-subject variability.

    Afrezza will fill a needed role for patients who do not wish to dose themselves for prandial insulin coverage with insulin from a needle injection. The rapid onset and offset of this insulin may well prove to be a great advantage in minimizing glucose fluctuations without much of the risk of late postinjection hypoglycemia. Now that MannKind signed a marketing agreement with the world’s largest insulin company, Sanofi, it is likely that Afrezza will soon be made available in many countries by way of a well-established distribution system. I look forward to seeing Afrezza used for mealtime insulin therapy in a closed-loop system and for many other situations where bolus insulin therapy is needed but late postprandial hypoglycemia is intolerable.

  • On June 27, 2014, the US Food and Drug Administration approved Afrezza (MannKind, Danbury, CT), an ultra-rapid-acting inhaled insulin to improve postprandial glycemic control in adults with diabetes mellitus. This is the only ultra-rapid-acting insulin on the market with faster pharmacokinetics and pharmacodynamics than the 3 rapid-acting insulin analogs currently on the market, which are insulin aspart, insulin glulisine, and insulin lispro.

    The name “Afrezza” refers to the drug/device combination product consisting of Technosphere insulin powder (known as TI), the inhaler, and the cartridges containing TI which is referred to as the Afrezza Inhalation System or the TI Inhalation System. TI is composed of recombinant human insulin and fumaryl diketopiperazine (FDKP), which is an inert excipient. Insulin powder particles are adsorbed onto uniform-sized (approximately 2 microns) carrier Technosphere particles which contain mostly crystallized FDKP. Upon inhalation, the Technosphere particles carry the insulin into the alveoli where the particles dissolve. Both the insulin and the FDPK are rapidly absorbed across the alveolar walls independently of each other. The insulin uptake into the blood stream is faster than that of any other approved insulin. The absorbed FDPK is not metabolized and is excreted in an inert form mostly by the kidneys.

    This approval was in response to the company’s third submission in 2013. After 2 previous cycles of review MannKind had received complete response letters on March 12, 2010, and January 18, 2011, because of multiple deficiencies identified by FDA in the prior applications. At one point in 2010, the company elected to drop their first generation delivery system (Medtone) and seek approval for their smaller second-generation delivery system (Gen2 also known internally as Dreamboat). FDA responded that a head-to-head comparison between the 2 inhalers would be needed, as well as a dose-proportionality study and a human factors study.

    The pharmacokinetic properties of TI are uniquely rapid of all approved insulins. The median time to maximum concentration in most subjects is 12-15 minutes. The PK of TI in subjects with type 1 diabetes, type 2 diabetes, and even smokers or those with chronic obstructive pulmonary disease is no different than that in unaffected controls. In asthmatic subjects insulin absorption may be decreased.

    Regarding the pharmacodynamics of TI, this drug has a more rapid onset of action and a shorter duration of action compared to rapid-acting insulin analogs. In glucose clamp studies, the maximum glucose infusion rate (tie of peak glucose-lowering activity) was 53 minutes for TI, 108 minutes for the analog insulin, and 3-4 hours for regular human insulin. The duration of Afrezza action is 2.5-3 hours.

    In their FDA submission, MannKind evaluated the safety and effectiveness of Afrezza in a total of 3017 subjects—1026 had type 1 diabetes and 1991 had type 2 diabetes. In 4 pivotal trials TI was either noninferior to comparator insulin in 2 of 3 trials and on the margin of noninferiority versus inferiority in 1 study (TI had a higher A1c than comparator with a 95% confidence interval as extreme as 0.40% worse than comparator with the prespecified noninferiority target set at

  • lakers_w lakers_w Dec 13, 2014 10:24 PM Flag

    When they signal an upgrade, they must be recovering shorts to repay the borrowed share. Then in Aug convert notes to stock at a fixed price to participate in the upside.

  • lakers_w lakers_w Dec 13, 2014 10:16 PM Flag

    Selling short against convertible notes is a common practice. They want shares lower than 5.55 to convert into stock. Nothing is unusual. Chances are A will do well. BofA will convert to repay the borrowed shrs. The conversion price is $6ish, right. They may miss a big run up though.

  • lakers_w lakers_w Dec 13, 2014 9:30 PM Flag

    BofA signals they will upgrade Mnkd after covering their short. Short covering will start in earnest soon. BofA ML is a good indicator since it's the first who breaks rank w/ shorts.

  • How investors can play the war against ‘globesity’

    Republish Reprint
    John Shmuel | December 11, 2014 6:06 PM ET
    More from John Shmuel | @jshmuel
    “We believe that the obesity epidemic may be the most pressing health challenge facing the world today,” said Sarbjit Nahal, Bank of America Merrill Lynch equity strategist and lead author of the report.
    AP Photo/Kirsty Wigglesworth, File“We believe that the obesity epidemic may be the most pressing health challenge facing the world today,” said Sarbjit Nahal, Bank of America Merrill Lynch equity strategist and lead author of the report.
    Twitter Google+ LinkedIn Email Comments More
    Efforts to fight the rising rate of global obesity are opening up new opportunities for investors, says a new report from Bank of America Merrill Lynch.

    There are currently 2.1 billion overweight people in the world, with 671 million of them classified as obese. The report notes most countries are trying to decrease that number for health reasons, but little progress is being made and health-care costs are rapidly expanding as a result.

    “We believe that the obesity epidemic may be the most pressing health challenge facing the world today,” said Sarbjit Nahal, equity strategist and lead author of the report. “The number of overweight or obese people has tripled since 1980 … by 2030, close to 50% of the world’s population is projected to be overweight or obese.”

    The report highlights four entry points for investors to play what it calls the fight against “globesity,” specifically stocks in pharmaceuticals and health care, food retail, weight-loss and nutrition, and sports apparel and equipment.

    Medical stocks are one of the hottest entry points, given the impact obesity has on health. In a report last month, Canaccord Genuity said that obesity is the “next big thing in medical devices.”

    Related
    The global economic cost of obesity has risen to US$2-trillion annually, study says
    Sugar accelerates aging process as much as smoking does, U.S. study says
    Advertisement

    Canaccord analyst William Plovanic identified EnteroMedics Inc., which develops neuro-blockers to treat obesity, as a promising company. He rates the stock, which closed Thursday at US$1.40 on the Nasdaq, as a buy with a US$4 price target.

    Mr. Nahal of BofAML, meanwhile, sees more than a dozen health-care and medical device companies as potential buys, including Arena Pharmaceuticals Inc., MannKind Corp. and Tandem, Inc.

    “Healthcare and medical device companies are playing an increasingly important role in dealing with the impact of obesity-related co-morbidities, including heart disease and failure, type 2 diabetes, kidney failure, respiratory complications, osteoarthritis and incontinence,” he said.

    Beyond health care, Mr. Nahal notes that food companies that fill the demand for organic and healthier foods should also benefit in the coming years as consumers shift toward a more health-conscious mindset to combat obesity. He identified stocks such as Sprouts Farmers Market Inc. and United Natural Foods Inc. as good bets.

    In the area of weight loss, diet and nutrition stocks, Mr. Nahal highlighted Glanbia PLC and GNC Holdings Inc. as two companies with high exposure to tackling global obesity.

    Finally, Mr. Nahal said companies that are part of the US$365-billion global athletic market, which includes sports apparel markets and gyms, will benefit as more people try to lose weight. He said PSG Ltd. and Under Armour Inc. are well positioned in that market.

  • Sanofi will only acquire Afrezza and GLP-1 but will continue to pay licensing for using Technosphere in their production plants... Hence the long partnership.

    Aftezza will be the first of many T-drugs that comes down the pipeline, which is why I think Afrezza will go for $16-$18 per share. The evil mnholdem would absolutely love it if shareholders were paid by a dividend and keep their shares in MNKD. This would demolish shorts, who would be required to pay the dividend to the borrower.

    That would be sweeter than restructuring and a stock split between two legal entities.

    By mnholdem

  • lakers_w lakers_w Dec 13, 2014 3:11 PM Flag

    Amen Duke of Danbury! This is what most experts and Trade Journal have been saying if you check. Hail to Kevin, the Suppreme Allies (NATO) Commander of the Grand Alliance! He has been right all along! Shorts, don't you dare reply until you provide me a written report of what you learn from the 62-of Speaker's Bureau Afrezza Lauch Material.

    In case you don't know what Speaker's Bureau is:

    Why do biopharmaceutical companies sponsor peer speaker programs for health care professionals?

    Doctors and other healthcare professionals with real-world clinical experience in specific therapeutic areas are uniquely qualified to educate and inform their peers about the medicines they prescribe. While physicians consult many sources for information, it can be a challenge for them to juggle the demands of clinical practice with the need to stay up-to-date with the latest science and FDA-approved treatment options.

    Interactions between physicians, including those participating in speakers bureaus, benefit patient care by facilitating the exchange of the latest FDA-regulated information (see below). This information exchange goes both ways: physicians provide pharmaceutical companies valuable feedback on how medicines are working for patients.

    What value do speakers programs provide in improving patient care?

    Interactions between healthcare professionals benefit patient care through the exchange of the latest regulated information about the benefits, risks and appropriate uses of medicines. Physicians need to stay up-to-date on information about new medicines, new uses of medicines, the latest clinical data, appropriate dosing and emerging safety issues.

  • lakers_w lakers_w Dec 13, 2014 2:58 PM Flag

    Pg 59, Pg 61 also mention Afrezza. Pg 61 said:
    Current State of the Art
    • Each of these approaches looks promising based on PK and PD studies
    • Each has its own issues regarding safety and/or practicality
    • None have been shown to have enhanced clinical efficacy for open-loop therapy except for MannKind insulin
    • None have been tested in closed-loop systems

    The slides detail the whole Solution incl. insulin pump Al sold to Medtronic. Now you can see Kevin's Grand Alliance and the triumvirate's closed-loop systems Grand Vision in its finest, awesome display.

  • lakers_w lakers_w Dec 13, 2014 2:36 PM Flag

    Dr. Bode has been a consultant, Member of the powerful Speaker's Bureau, received Grant Research and Support from the triumvirate Mannkind, Medtronic, Sanofi. Do you see the Grand Alliance in the making? It will never become clearer than this. Do you have to wait for flop, turn, river before making a bet? Isn't it time to Up the Ante? I give credit to Kevin for spotting this first and getting lots of arrows, bullets for it. You tireless passion will be handsomely rewarded. Danbury check! Valencia check! NJ check! Paris check! Minneapolis check ! All Systems Go! 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, Take Off !!

  • lakers_w lakers_w Dec 13, 2014 2:14 PM Flag

    Attention Everyone !! Make sure you download it to share with others before it's taken offline.

  • Do We Really Need Ultra-Fast Acting Insulins?
    Bruce W. Bode, MD, FACE Atlanta Diabetes Associates Atlanta, Georgia

    Consultant: Novo Nordisk, MannKind, Medtronic, Sanofi
    • Speaker’s Bureau: Lilly, Novo Nordisk, Medtronic, Sanofi
    • Grant and Research Support: Biodil, Lilly, MannKind, Medtronic, Sanofi

    ucdenverDOTedu/academics/colleges/medicalschool/centers/BarbaraDavis/OnlineBooks/Documents/Keystone2011/Keystone%202011%20Bode%20Ultra%20Fast%20Acting.pdf

    Afrezza is mentioned 17 times on pages
    19,45,48,51,52,53,54,55,56,58 of 62

    You guys are too harsh on Mnkd and Sanofi mgmt. They're doing a phenomenal Afrezza launch job behind the scene. No wonder Pipper Jaffray Top 15 2015 Bio Pharma Suprises lists "Mnkd/Sny launch goes well" at #6. Since I am working my butt off too, Longs or Shorts, can you promise to read 62 pages in their entirety before replying? They deserve your undivided attention.

  • lakers_w lakers_w Dec 12, 2014 8:15 PM Flag

    8. PD1 antibodies start to look like a thing of the past
    9. AMGN blocks REGN/SNY's PCSK9 antibody
    10. A biosimilar Soliris enters Phase 3
    11. Gene therapy cures blindness
    12. Iran gets the nuke; military spending hikes force other budget cuts
    13. Two large-cap biotechs get acquired
    14. CBD hits the radar screen for autism
    15. ProQR transforms the CF landscape

    Could bluebird bio (BLUE) Cure Sickle Cell Anemia in 2015? Is Big Bio in Pharma Radars?
    December 12, 2014 11:58 AM EST
    streetinsiderDOTcom/Analyst+Comments/Could+bluebird+bio+(BLUE)+Cure+Sickle+Cell+Anemia+in+2015%3F+Is+Big+Bio+in+Pharma+Radars%3F/10093058.html

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