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Post by mannmade on Sept 28, 2016 19:56:54 GMT -5
If only the medical world truly understood AFREZZA.... sigh!! I hope Dexcom now understands the importance and real world benefits of AFREZZA now... Maybe some competition from Medtronics will spur them to partner with AFREZZA for a trifecta of CGM, Basal, and AFREZZA as a "poor man's AP,' that may just have a more benefits with almost as good results for less cost to insurance etc... One can dream...
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Post by mannmade on Sept 28, 2016 19:56:11 GMT -5
The below 3 paragraphs pulled from an article on Yahoo today explain exactly why an AP is nothing without AFREZZA. Conversely a CGM, basal 1 to 2x day and AFREZZA are almost as good if not better in some respects than an AP. Oh the irony that it is from Medtronics... This may actually be good for AFREZZA.
However, figuring out exactly how much insulin to give is no easy task. Both too much and too little insulin can have dangerous, even deadly consequences.
And that’s where this new technology will help. The device has a continuous glucose monitor that constantly measures blood sugar levels. A sophisticated computer algorithm then figures out if someone’s blood sugar levels are too low or too high, and when too high, will give the correct insulin dose to bring the blood sugar level down.
The device does this via a small catheter inserted beneath the skin and attached to a tube that’s attached to an insulin pump. This insulin delivery site needs to be changed approximately every three days.
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Post by mannmade on Sept 28, 2016 19:43:29 GMT -5
Meanwhile FDA approved 1hr ago First Artificial Pancreas for T1: “This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” said the FDA’s Jeffrey Shuren about the approval. Medtronic reportedly filed for FDA approval of the MiniMed in June and received regulatory clearance rapidly thanks to the company’s cooperation with the agency. “Given the earlier-than-anticipated approval and the novel nature of the technology, we plan to begin shipping the MiniMed 670G system in spring of 2017,” said Hooman Hakami, executive vice president at Medtronic Diabetes, in a statement. “This timeline ensures market and manufacturing readiness, payer coverage, and appropriate training of our employees, clinicians, educators, and customers on the new system.” So will T1's start to use AFREZZA with AP? As they did with trials in Santa Barbara? Hmmm....
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Post by mannmade on Sept 28, 2016 15:49:58 GMT -5
My opinion/understanding is the following:
1. It will be expensive 2. Still rather bulky and inconvenient 3. Results still not that much better than a CGM, AFREZZA and a basil, (yes I know this depends on how diligent one is) 4. If T1's are looking to drop pump (and many are able to do so with an Hba1c in the mid 5's to low 6's) why get hooked to an AP? 5. More moving parts and chances for something to go wrong. I have a friend whose son almost died because his pump was not calibrated properly 6. Oh yeah... didn't the Samsun trials in Santa Barbara for an AP use AFREZZA?
Can't get a Dexcom approved very easily how will insurance look at an AP?
Just my initial thoughts... AFREZZA is simpler, less expensive, almost as able to get same results, and likely to some degree more convenient... But I am not diabetic so would love to hear from someone who is...
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Post by mannmade on Sept 28, 2016 15:44:01 GMT -5
This should be great for Dexcom... But also AFREZZA the only real time insulin... www.news-medical.net/news/20160926/Endocrine-Society-Clinical-Practice-Guideline-recommends-CGMs-for-Type-1-diabetes-patients.aspxEndocrine Society Clinical Practice Guideline recommends CGMs for Type 1 diabetes patients Published on September 26, 2016 at 4:20 PM · 1 Comment inShare 39 Share12 The Endocrine Society today issued a Clinical Practice Guideline recommending continuous glucose monitors (CGMs) as the gold standard of care for adults with Type 1 diabetes. The guideline, titled "Diabetes Technology—Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline," was published online and will appear in the November 2016 print issue of The Journal of Clinical Endocrinology & Metabolism (JCEM), a publication of the Endocrine Society. An estimated 29 million Americans have diabetes, according to the Society's Endocrine Facts and Figures Report. The condition occurs when the body's ability to process sugar is impaired. Among individuals with Type 2 diabetes, the body either makes too little insulin, the hormone that processes sugar, or the body uses insulin inefficiently. An individual develops Type 1 diabetes—the less common form of the condition—when the body produces little to no insulin. Continuous glucose monitors (CGMs) are primarily used to help in the management of Type 1 diabetes, although the devices can be useful for people with type 2 diabetes, as well. CGMs measure glucose levels in the fluid between the body's cells every few minutes throughout the day and night. The technology can tell the user whether glucose levels are rising or falling, and monitor trends from the past several hours. The devices also feature alarms to warn users when glucose levels are too high or too low. "Studies have found that people with Type 1 diabetes who use CGMs are able to maintain better control of their blood sugar without increasing episodes of hypoglycemia when blood sugar drops to dangerous levels, compared to those who self-monitor blood glucose with periodic fingersticks," said Anne L. Peters, MD, of the University of Southern California's Keck School of Medicine in Los Angeles, CA, and chair of the task force that authored the guideline. "Scientific evidence supports the use of CGM technology in individuals with Type 1 diabetes whose blood sugar is above the targeted level as well as those whose blood glucose is well managed." Related Stories Exposure to air pollution at place of residence could be risk factor for type 2 diabetes Stealth insulin-producing pig cells may offer solution for treating Type 1 diabetes in humans Researchers discover protein that plays role in onset of type 1 diabetes The guideline task force gave its strongest recommendation in support of using CGM technology in individuals with Type 1 diabetes who are able and willing to use the monitors. The task force also suggested that CGMs can be used on a short-term, intermittent basis for individuals with Type 2 diabetes whose blood glucose is above targeted levels. Although many people with Type 1 diabetes use CGMs, Medicare does not cover the technology for adults 65 and older. The Endocrine Society continues to call for Medicare coverage to improve outcomes and reduce hypoglycemic events in older adults. The guideline task force also recommended the use of insulin pumps over multiple daily insulin injections in individuals with Type 1 diabetes who have not met their A1C goals and are willing and able to use the device. In addition, pumps are recommended for people with frequent hypoglycemia or glucose variability, and those who require increased insulin delivery flexibility or improved satisfaction with their diabetes care. Insulin pump use was suggested for people with Type 2 diabetes who were not meeting their glycemic goals. Insulin pumps deliver insulin around the clock via a catheter placed under the skin. The pump gives additional insulin before meals based on what the user enters for their food intake and blood sugar level. Insulin pumps are often used in conjunction with CGMs. Emerging technology in the treatment of diabetes, including artificial pancreas devices, are designed to automatically manage blood sugar levels in individuals with Type 1 diabetes. Such technologies will use CGM to effectively monitor blood sugar to determine appropriate insulin dosages and to prevent blood sugar levels from going too low or too high. Regardless of what treatment technologies are used, the guideline recommends that all patients and healthcare providers be properly educated and trained to use the devices. "A device's success is directly linked to an individual's willingness to use and understand the technology," Peters said. "It is crucial to ensure patients are comfortable with any devices they decide to incorporate into their treatment plans."
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Post by mannmade on Sept 27, 2016 21:00:46 GMT -5
All in good fun... among friends...
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Post by mannmade on Sept 27, 2016 20:05:59 GMT -5
Given the complexity of drug pricing with insurance companies and middlemen like Express Scripts and the fact that AFREZZA is now within the same price range as Novolog and Humalog I do not personally think we should be lowering the price at this time. Especially given the current environment in Congress re; Pharma and drug prices/increases. Our likely next president has already gone on record as saying this is an issue that needs to be dealt with... so it may not be easy to raise prices in the future depending on any forthcoming regulations... And imho price is not the real obstacle.
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Post by mannmade on Sept 27, 2016 17:08:18 GMT -5
The other reason is for those who shorted at a higher price and have yet to cover... imho...
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Post by mannmade on Sept 26, 2016 22:19:23 GMT -5
medicalxpress.com/news/2016-09-theory-insulin-resistance-metabolic-disease.htmlHome Diabetes September 26, 2016 New theory on how insulin resistance, metabolic disease begin September 26, 2016 insulin High-resolution model of six insulin molecules assembled in a hexamer. Credit: Isaac Yonemoto/Wikipedia Does eating too much sugar cause type 2 diabetes? The answer may not be simple, but a study published Sept. 26 in the Journal of Clinical Investigation adds to growing research linking excessive sugar consumption—specifically the sugar fructose—to a rise in metabolic disease worldwide. The study, conducted in mice and corroborated in human liver samples, unveils a metabolic process that could upend previous ideas about how the body becomes resistant to insulin and eventually develops diabetes. The increasing prevalence of diabetes is considered a health epidemic as more than 29 million people in the U.S. have diabetes and another 86 million have pre-diabetes, according to the Centers for Disease Control and Prevention. "There is still significant controversy as to whether sugar consumption is a major contributor to the development of diabetes," said senior author Mark Herman, M.D., assistant professor in the Division of Endocrinology, Metabolism, and Nutrition at Duke University School of Medicine. "Some investigators contend that commonly consumed amounts of sugar do not contribute to this epidemic," Herman said. "While others are convinced that excessive sugar ingestion is a major cause. This paper reveals a specific mechanism by which consuming fructose in large amounts, such as in soda, can cause problems." Insulin is a key hormone that regulates blood glucose after eating. Insulin resistance, when the body's metabolic tissues stop responding normally to insulin, is one of the earliest detectable changes in the progression to diabetes. However, according to this study, the cause of insulin resistance may have little to do with defects in insulin signaling and might actually be caused by a separate process triggered by excess sugar in the liver that activates a molecular factor known as carbohydrate-responsive element-binding protein, or ChREBP. The ChREBP protein is found in several metabolic organs in mice, humans and other mammals. In the liver, it is activated after eating fructose, a form of sugar naturally found in fruits and vegetables, but also added to many processed foods including soft drinks. The study found that fructose initiates a process that causes the liver to keep making glucose and raising blood glucose levels, even as insulin tries to keep glucose production in check. "For the past several decades, investigators have suggested that there must be a problem in the way the liver senses insulin, and that is why insulin-resistant people make too much glucose," Herman said. "We found that no matter how much insulin the pancreas made, it couldn't override the processes started by this protein, ChREBP, to stimulate glucose production. This would ultimately cause blood sugar and insulin levels to increase, which over time can lead to insulin resistance elsewhere in the body." Herman is new to Duke and led the research over the past four years at Beth Israel Deaconess Medical Center at Harvard University with collaborators from the University of Massachusetts Medical School and Pfizer Inc. To test their hypothesis, researchers studied mice that were genetically altered so their liver insulin signaling pathways were maximally activated—in other words, their livers should not have been able to produce any glucose. The researchers found that even in these mice, eating fructose triggered ChREBP-related processes in the liver, causing it to make more and more glucose, despite insulin signals telling it to stop. Previous studies have reported that high fructose diets can cause multiple metabolic problems in humans and animals, including insulin resistance and fatty liver disease. Because most people found to be insulin-resistant also have fatty liver, many investigators have proposed that the fructose-induced fatty liver leads to liver dysfunction, which causes insulin resistance, diabetes and high risk for heart disease. The new findings suggest fatty liver disease may be a red herring, Herman said. The likely cause of insulin resistance may not be the buildup of fat in the liver, as commonly believed, but rather the processes activated by ChREBP, which may then contribute to the development of both fatty liver and increased glucose production. Although much more research is required, the scientists believe they better understand a key mechanism leading to pre-diabetes and can now explore how to possibly interrupt that chain of events. ChREBP may not be the only pathway by which this happens, and the protein may also be activated in other ways, Herman said. But the study provides an important lead, he said. "It gives us some insight into what may be happening early in diabetes," Herman said. "If we can develop drugs to target this process, this may be a way to prevent the process early in the development of the disease." The finding could also help scientists one day diagnose metabolic disorders earlier on, potentially allowing patients to make changes to their diets and lifestyles sooner to prevent more serious complications. As a medical doctor, Herman said the advice to patients remains the same: make sure you're not eating too much sugar, which often shows up on labels as sucrose (the main ingredient in beet and cane sugar) and high fructose corn syrup. Both sweeteners contain both glucose and fructose and are rapidly absorbed, he said. In its naturally occurring form and quantity, fructose is not particularly harmful, Herman explained, because if you're eating an apple, for example, you're eating a relatively small amount of sugar and it's combined with other nutrients such as fiber that may slow its absorption. "You could eat three apples and not get the same amount of fructose you might get from a 20-ounce sugar-sweetened beverage," he said. "The major sources of excessive fructose are in foods like sodas and many processed foods, which are foods most doctors would say to limit in your diet." Explore further: Researchers link obesity and the body's production of fructose
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Post by mannmade on Sept 26, 2016 19:24:29 GMT -5
So many impressive potential opportunities. Until something materializes, I have to reiterate, Mannkind is the heavy weight champion of the world who hasn't won a single fight. All the boasting means squat when you're trading at 50 cents and barely enough cash to pay rent for the next 6 months. I respectfully disagree with your analogy. I would say they are the underdog in a heavy weight fight and have won a few rounds but the outcome of the fight is still tbd. Have they been gut punched and knocked down a few times? Most certainly, but they are still in this fight...
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Post by mannmade on Sept 26, 2016 18:04:40 GMT -5
www.fool.com/investing/2016/09/24/biotech-stocks-under-5-2-to-buy-1-to-avoid.aspxBiotech Stocks Under $5: 2 to Buy, 1 to Avoid Some beaten-down biotechs might be worth the risk, while others are better left alone. George Budwell (TMFGBudwell) Sep 24, 2016 at 9:02AM Biotech stocks with share prices under $5 are generally too dangerous to own. Even so, some of these dirt-cheap biotechs can, on rare occasion, represent compelling growth opportunities for risk-tolerant investors. With this in mind, here's a look at why you may want to buy Amarin Corp. (NASDAQ:AMRN) and Geron Corp. (NASDAQ:GERN), but avoid MannKind Corp. (NASDAQ:MNKD) right now. Images IMAGE SOURCE: GETTY IMAGES. Don't let the pessimism fool you -- Amarin is grossly undervalued Amarin's first interim efficacy analysis for fish oil pill Vascepa's REDUCE-IT cardiovascular outcomes study has now come and gone without much fanfare. While the trial wasn't halted early for efficacy reasons -- as some investors were apparently hoping -- the trial also wasn't stopped for futility. As such, Amarin will sally forth toward a second interim analysis that's expected to occur by mid-2017. While it's impossible to tell if Vascepa is even trending toward significance in terms of its ability to reduce the likelihood of deadly cardiovascular events in this large outcomes study, the company is arguably deeply undervalued relative to its near-term growth prospects. Because of a favorable ruling allowing Amarin to talk to doctors about Vascepa's benefits in patients with moderately high triglyceride levels (as opposed to just those with severely high triglyceride levels), the Street is forecasting the drug's sales to basically double from 2015 over the next two years. The net result is that Amarin's shares are trading at less than three times the company's projected 2017 revenue, which is rock bottom for a revenue-generating biotech. Now, the catch is that Amarin is probably going to have to continue to raise capital to fund the cash-intensive REDUCE-IT trial. After all, Vascepa's growing sales don't appear to be high enough to fully cover the cost of this trial, and REDUCE-IT isn't scheduled to conclude until 2018. That said, management has enough of a cash runway at the moment to execute capital raises in a judicious manner that should minimize the impact on its share price going forward. Geron's stock is down, but not out After announcing the interim results for Johnson & Johnson's (NYSE:JNJ) ongoing trials assessing Geron's telomerase inhibitor imetelstat in the blood disorders myelofibrosis (MF) and myelodysplastic syndromes (MDS) earlier this month, Geron's stock took a big hit: GERN Chart GERN DATA BY YCHARTS. The key concern is that imetelstat doesn't seem to be exhibiting quite the same level of clinical benefit in MF in its mid-stage trial as its earlier pilot study produced. Turning to the specifics, J&J's subsidiary Janssen Biotech, which is conducting the trials, decided to close patient enrollment in the 4.7 mg/kg dosing arm of the study. And while Janssen is continuing to evaluate the higher 9.4 mg/kg dosing arm of imetelstat in MF due to an "encouraging trend in efficacy," it's worth noting that this arm also didn't meet the protocol defined interim criteria yet, according to the press release. The good news is that imetelstat appears to be producing a more pronounced clinical benefit in MDS, although neither Geron nor J&J provided many details on the drug's progress in this separate study. Going forward, J&J is expected to provide another clinical update for this trial in the second quarter of 2017, followed by a decision on whether or not to advance imetelstat into a late-stage study for MDS by mid-2017. Although the market clearly expected imetelstat to produce much clearer signs of efficacy in perhaps both MF and MDS, this dramatic sell-off probably isn't warranted for two reasons. First off, these high-value indications both remain in play at this stage. J&J, after all, wouldn't be wasting its time and resources if this initial data didn't show at least some promising signs of efficacy. Next up, Geron is in a fairly strong financial position as a result of its partnership with J&J. This situation could change if Geron decides to diversify its pipeline. But that event seems highly unlikely at this point given that the biotech is basically structured (skeleton crew for staff, no real internal R&D capabilities) for a quick sale, not conducting clinical trials. All told, Geron's main value driver imetelstat may not be performing up to the Street's high expectations, but it also hasn't crashed and burned just yet. And with a cash runway that should extend well beyond imetelstat's forthcoming clinical updates for MF and MDS, this biotech looks like an intriguing speculative buy. MannKind is taking on water MannKind's value proposition centers around its inhaled insulin product, Afrezza. Afrezza was originally billed as a potential megablockbuster due to the enormous size of the diabetes market and the notion that patients would flock to an inhalable insulin. However, the product faced several hurdles to its commercial launch right out of the gate, such as a lukewarm response from payers and burdensome lung-function tests, which resulted in unexpectedly poor sales. In turn, MannKind's marketing partner for Afrezza, Sanofi, decided to terminate its marketing agreement earlier this year. Afrezza IMAGE SOURCE: MANNKIND CORP. As it now stands, MannKind is tasked with reviving Afrezza's anemic commercial launch on a shoestring budget. Making matters worse, this biotech is on track to run out of cash by mid-2017, and the company's sub-$1 share price may preclude it from tapping the balance of its $50 million of at-the-market stock offerings. And even with roughly $30 million remaining under its loan agreement with The Mann Group, MannKind may struggle to keep its doors open beyond next year. Long story short, MannKind desperately needs Afrezza's sales to grow at an exponential rate in order to stave off bankruptcy, and that no longer looks like a real possibility without Sanofi's backing. That's why investors may want to shy away from this name for the time being.
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Post by mannmade on Sept 26, 2016 17:38:15 GMT -5
Has anyone thought that maybe the CEO, Matt Pfeffer, has become incapable of dealing with the circumstance that Wall Street has driven Mannkind into,particularly after he publicly went on the record that launch 2.0 would succeed. I think it only steeled the forces against the company and they shortened the leash that they already had the company on. Not for a second...
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Post by mannmade on Sept 26, 2016 17:34:08 GMT -5
But you appear cool and calm...
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Post by mannmade on Sept 26, 2016 17:20:43 GMT -5
As a child I remember hearing the saying that "Silence is Golden..." So while many here take it as a bad thing at the moment, I do not... I think it may lead to something better when the time becomes appropriate. There is likely a reason for it at the moment and I trust the motivations of the management team so I think it is a positive and not a negative...
And amid the silence there are concrete positive signs:
1. JDRF Booths, the very first step in the development of the MannKind partnership with the JDRF 2. Mike's tweet that he is not worried 3. NRx numbers are the highest they have been since May I believe (based on my memory of seeing Liane's chart, although I could be off a few weeks either way) 4. Epi development was ahead of the curve and makes MannKind even more relevant in the world of Pharma given the current discussions on pricing of Epi pens 5. Use of Laura Kronen in marketing, where was Sanofi's relationship with real world users? 6. Minitaka partnership that was recently acknowledged in their video posted on this site 7. RSL, even though we have yet to hear details, we have been told to expect, albeit likely nominal, a milestone payment from them in 4th Q 16' 8. Mike investing his own money and Matt too to buy more shares after it appeared as a concern on this board. And you think they don't listen? Seriously why should they buy shares on the open market when they get options? 9. Listing on the TASE
And the above list does not include:
1. New sales force from scratch 2. Hiring of Nurse Practitioners 3. New Web site 4. MannKind Cares 5. Manufacturing change over 6. Titration paks
Other more speculative opportunities that may or may not happen sooner than later:
1. Settlement with Sanofi 2. Epi partnership 3. Jump in weekly scripts 4. Label Change 5. Official start of pediatric studies
To me this is all positive, some more speculative than others but all good and certainly not reflective of the current share price. I will buy more (my personal opinion not offered as advice) as soon as the money situation is sorted out. I believe as I have said before that I do not think dilution at this point (subject to terms but recognizing/accepting of current financial situation the terms will not be in our favor as if s/p were higher) that dilution is a bad thing. Some dilution has imo been priced in while the rest of the decline in s/p, if and when dilution happens, will drive the price down more in the short term but when people/investors realize it has taken finances off the table as an issue (assuming we get 12 months worth of cash burn) then I think the price will begin to come back up especially in light of the above, and that's when I will start to buy.
I get that people are handling this in different ways... And everyone has a different level of involvement, tolerance and own need/reason for doing what they do on this board. Some are pure and simple or straight forward, others are less so to varying degrees...
I have been a shareholder since 2009 and I am not stressed nor angry. As who would I get angry at? Myself I guess, as I am the only one to blame for my decisions. Every decision I have made so far regarding MannKind has been under my control. I could of sold when it hit $11.48 the night of the FDA Ad Com Vote but I chose not too. Could have sold anytime since but have chose not too. Hindsight is a beautiful thing when you are right...
I continue to believe in the science, I continue to believe that Matt, Mike, et al.. are doing a very good job under the circumstances... And I continue to believe that Al Mann's legacy, the health of diabetics and my personal investment in time, effort and capital are worth it even if not reflected in the current share price.
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Post by mannmade on Sept 26, 2016 16:41:33 GMT -5
boom you make a good point. I do believe it started this way to help with compliance as one shot per day was better than three. Most T2's don't want to go on insulin. And it is my understanding that this thought process is starting to change. I do believe in speaking with several doctors that they are starting to see it the same way. (I am not a medical person but have had this same conversation with doctors while discussing the merits of AFREZZA.)
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