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Post by lakers on Aug 24, 2016 15:43:09 GMT -5
Ray said,
seekingalpha.com/article/3809206-mannkinds-mnkd-ceo-matt-pfeffer-presents-at-34th-annual-jpmorgan-healthcare-conference-transcript?part=single
Some of the other products are going to be orally inhalation, but for systemic delivery. You can see a few there and I'll mention just a few parathyroid hormone for example. The PK profile of PTH delivery using our innovative device gives a pulsatile or burst-like activity.
This is very similar to what happens physiologically. We believe that this would lead to an increased efficacy and decreased safety issues compared to the current product that’s on the market.
The physiometric profile of drugs that we give via this route shouldn’t be surprising to you. It’s identical to what we see with Afrezza as we laid it to insulin.
Another product that's on air that's related or very closely related to our PK profile of being very high Cmax short Tmax partially you see being high, very conducive to efficacy in acute care types of conditions. So we are looking at Epinephrine in the anaphylaxis situation.
These are the three drug candidates that we have in our development pipeline as of today, sorry. One being [true] [ph] for PAH I believe that our previous administration has mentioned this several times.
We have three formulations tested and two of three are advancing. Palonosetron for Chemo and to nausea, we think this is an incredibly good asset from moderately mutagenic chemotherapeutic regimens. We have two formulations that are being tested next week and epinephrine for Anaphylaxis, we actually are testing formulations within the next week or two.
Of note for those of you who may think that a development program such as [True] [ph] may be costly, which I would agree, but when you look at the IND-enabling phase or the tech assessment phase, this is a relatively inexpensive from a capital standpoint. Most of the expense would come from already existing FCEs, which would be fairly immaterial. As we move into the clinical phases, Phase I and II well as you know the cost would go up tremendously. It is at that time that we would start looking for potential partners. So we either absorb most of that cost or through cost sharing. That’s the business opportunity that’s showing up on the bottom of the slide.
This is the same sort of concept for Palonosetron and again we would be doing most of the tech assessment phase by ourselves and the preclinical work, looking for partners as we move along the value proposition line in the IND phase or the clinical phase.
The last slide, the last one of our clinical development candidates is Epinephrine for Anaphylaxis. I think the one point I want to raise here is this can be an incredibly short timeline. No real clinical studies would be required. Obviously you cannot do a clinical study in the Anaphylactic setting. So that would be e-study and some human factor studies would probably suffice. So we're looking at this opportunity as again one of our priority ones.
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Post by lakers on Aug 23, 2016 20:39:11 GMT -5
How EpiPen's maker raised prices, and hackles, so much www.usnews.com/news/business/articles/2016-08-23/how-epipens-maker-raised-prices-and-hackles-so-muchThe company, Mylan, has a virtual monopoly on epinephrine injectors, potentially life-saving devices used to stop a runaway allergic reaction. Mylan N.V., which has headquarters in Hertfordshire, England, and Pittsburgh, has hiked prices as frequently as three times a year over the past nine years, pushing its list price for a package of two syringes to more than $600. A look at the situation: Q: Who uses EpiPens? Roughly 40 million Americans have severe allergies to spider bites, bee stings and foods like nuts, eggs and shellfish. They at risk for a serious reaction — anaphylactic shock. Symptoms quickly escalate from wheezing, hives and skin swelling to rapid heartbeat, trouble breathing and convulsions and, without treatment, possibly death. As a precaution, many carry EpiPens, which contain the best "antidote," the hormone epinephrine. Last year, more than 3.6 million U.S. prescriptions for two-packs of EpiPens were filled, according to data firm IMS Health. That earned Mylan nearly $1.7 billion. Q: How did the price for EpiPens get so high? Like all drugmakers, Mylan periodically hikes its prices. In 2007, when Mylan took over rights to EpiPen, a pair of syringes cost $93.88. According to Elsevier Clinical Solutions' database of prices set by manufacturers, Mylan raised the price 5 percent the in 2008 and 2009, when a competitor hit the market. Its price jumped 20 percent in late 2009, followed by a series of 10 percent and 15 percent increases. The price hit $609 per pair in mid-May. Q: Isn't there any competition? A: Barely, and few people know about it. One cheaper product remains on the market, Adrenaclick. But EpiPen, introduced in 1987, is so well known that most doctors prescribe it without considering Adrenaclick, and pharmacists can't substitute that for EpiPen, said Evelyn Hermes-DeSantis, director of drug information services at Rutgers University's pharmacy school. A pair of Adrenaclick syringes costs $142 to $380 at pharmacies, according to online comparison sites. EpiPen has a U.S. patent giving it a monopoly until 2025, according to Evercore ISI analyst Umer Raffat. Generic maker Teva has permission to launch a version but hasn't gotten regulatory approval yet. A rival injector called Auvi-Q was recalled last year because of potential inaccurate dosing, Raffat noted, and a third product has twice been rejected because of issues with the injector. Q: Is there another alternative? A: Some people get prescriptions for epinephrine vials and get a doctor to put it in syringes. But Rutgers' Hermes-DeSantis said that raises concerns about sterility and proper storage.
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Post by lakers on Aug 23, 2016 0:51:21 GMT -5
EpiPen Price Hikes: What to Know news.google.com/news/ampviewer?caurl=https%3A%2F%2Famp.webmd.com%2Fallergies%2Fnews%2F20160822%2Fepipen-price-hikes-what-know.html#pt0-361489EpiPen Price Hikes: What to Know Aug. 22, 2016 -- The rising cost of a life-saving allergy drug dispenser is raising eyebrows at the pharmacy counter and on Capitol Hill. The price of the EpiPen, which treats severe allergic reactions, has gone up sixfold in recent years. It can cost as much as $700 for a pack of two auto-injectors before insurance. Parents of children with food allergies in particular are up in arms, and the increase has drawn the ire of some federal lawmakers. WebMD asked experts to explain the price increases and what those who need EpiPens can do. What’s an EpiPen, and how is it used? EpiPen is the trade name for the most common type of epinephrine auto-injector. It’s a spring-loaded, pre-filled syringe that delivers a single dose of epinephrine. The drug, a man-made version of adrenaline, a hormone made by our bodies, is used to counter a potentially life-threatening allergic reaction known as anaphylaxis. It’s designed to be jabbed into the outside of your thigh, which triggers the spring and sends the needle into your leg. Auto-injectors like the EpiPen are much faster and simpler than drawing a dose of epinephrine out of a vial into a syringe and injecting it into a vein. Their speed and convenience has made them popular among people with life-threatening allergies.
“That’s been proven to be a much more dependable source of treatment, especially for children,” says Bob Lanier, MD, the executive medical director of the American College of Asthma, Allergy and Immunology. How expensive is it? Epinephrine, commonly known as adrenaline, is cheap. The dose in an auto-injector can cost as little as $1, Lanier says. It’s the mechanism that’s expensive, largely because it has to meet tough government standards for reliability. Like a parachute, “It has to work every time,” he says. But the price of the EpiPen has gone up sharply in the past several years. In 2008, pharmacists’ cost for a two-pack of EpiPens was less than $100. As of May, it was running just over $600, according to the Elsevier Gold Standard Drug Database, which tracks U.S. wholesale drug prices. Retail prices can top $700 or more before discounts or insurance reimbursements, according to DrugRx.com, a website that compiles consumer prices. That’s steep enough for one set. But many people find themselves having to buy several sets of auto-injectors a year to keep at schools or at relatives’ or caregivers’ homes. And the EpiPen has a 1-year expiration date, which means that becomes an annual cost.
That’s where the real issues come in,” Lanier says. “You’re taking about thousands of dollars a year on an indefinite basis.” Why did they get so expensive? The pharmaceutical company Mylan, which bought the EpiPen from Merck in 2007, says more people are buying higher-deductible health plans, meaning they’re paying more for drugs that may have been covered before. “With changes in the healthcare insurance landscape, an increasing number of people and families are enrolled in high-deductible health plans, and deductible amounts continue to rise,” Mylan says in a statement to WebMD. “This shift, along with other insurance landscape changes, has presented new challenges for consumers, and they are bearing more of the cost.” There’s something to that, Lanier says. The Affordable Care Act has resulted in many new high-deductible insurance policies being sold on the Exchanges the landmark health-insurance law set up. Nicole Smith, whose son’s experience with food allergies has led her to become an advocate for children with similar issues, says that doesn’t account for the drastic increases. She says Mylan has turned the EpiPen into a “cash cow,” jacking up prices while it enjoys a near-monopoly position, and is calling for a federal probe of the company’s price increases. “I would like to see them publicly brought to task for this,” Smith says. Mylan told CBS News last week the EpiPen's price "has changed over time to better reflect important product features and the value the product provides," saying "we've made a significant investment to support the device over the past years." The advocacy group Food Allergy Research & Education points out that Medicaid, the federal health-insurance program for the poor, covers epinephrine in all 50 states. But with no serious competition, people with those high-deductible insurance plans end up paying retail price, says James Baker, MD, FARE’s chief medical officer and CEO. The drug’s manufacturer, insurers, and others should justify the increased cost, he says. Can I buy an alternative to the EpiPen? While EpiPen is the biggest player in the market, there’s a version called Adrenaclick, which delivers the same drug with a different injector. A two-pack sells for between $140 and about $375, according to GoodRx. Another auto-injection device, known as Auvi-Q, was pulled off the market in October 2015 after regulators found problems with it delivering an inaccurate dose of epinephrine -- or failing to inject the drug entirely. Auvi-Q’s manufacturer is expected to resubmit the device for approval, Lanier says. Then there’s the old-fashioned way: A syringe filled with the proper dose of epinephrine. It’s not as simple as the EpiPen, but it still does the job and remains the typical method in other countries. “It’s not a difference between a life-saving drug and nothing,” Lanier says. “They have the difference between an auto-injector and an epinephrine syringe.” I’d rather stick with the EpiPen. Can I get a break on the price? Mylan promotes what it calls a “$0 Copay” card, which provides a discount of up to $100 on a two-pack of EpiPens at the pharmacy. The company says more than 80% of the people who got EpiPens through their insurance company paid nothing in 2015. The company also offers a program to help low-income, uninsured patients get EpiPens. And since 2012, Mylan says it has distributed more than 650,000 auto-injectors to U.S. schools, many of which are now required to keep epinephrine auto-injectors on hand.
Will this change anytime soon?
FARE says it’s trying to get additional manufacturers to jump in and bring the price down, Baker says. But he says, “None of these efforts will provide immediate relief.”
Lanier says it typically takes three competing products in a market to start bringing prices down. Short of that additional competition, there are two other things that might help curb the costs. Regulators could approve new epinephrine products like an oral dose, or add epinephrine to the list of preventive medicines that insurance plans have to cover under the ACA.
But whether that would require them to cover the auto-injection mechanism? “That’s the $64,000 question,” he says. We are lucky to have hired Ray, formerly Mylan CMO, who understood Epi Pen so well that he championed TS Epi to be the lead TS product.
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Post by lakers on Aug 23, 2016 0:01:35 GMT -5
EpiPen Price Rise Sparks Concern for Allergy Sufferers A steep increase in the price of the EpiPen, a lifesaving injection device for people with severe allergies, has sparked outrage among consumers and lawmakers who worry that parents won’t be able to afford the pens for children heading back to school. With a quick stab to the thigh, the EpiPen dispenses epinephrine, a drug that reverses swelling, closing of the airways and other symptoms of a severe allergic reaction to bee stings, peanuts or other allergens. Mylan, the pharmaceutical company, acquired the decades-old product in 2007, when pharmacies paid less than $100 for a two-pen set, and has since been steadily raising the wholesale price. In 2009, a pharmacy paid $103.50 for a set. By July 2013 the price was up to $264.50, and it rose 75 percent to $461 by last May. This May the price spiked again to $608.61, according to data provided by Elsevier Clinical Solutions’ Gold Standard Drug Database. Doctors advise allergic patients to carry two EpiPens with them at all times in case an extra dose is needed to quell a severe reaction. Most parents buy multiple EpiPens for home, in the car and school and may replace them annually, depending on the expiration date. Mylan has declined to comment on the price hike, issuing a statement pointing the finger at high-deductible health plans that require consumers to pay much more out of pocket for many drugs. The company said a $100 coupon they offer for the product means most people don’t pay anything for the pens. But how the price hike affects consumers varies widely, depending on the prices charged by their local pharmacy and the details of their insurance plan. People without insurance or with high-deductible insurance plans can’t always use the coupon and are paying about $640 a set, said Michael Rea, the chief executive of Rx Savings Solutions in Overland Park, Kan. Other patients say that even with good insurance, their copayments are as much as four times higher than in the past. Naomi Shulman of Northampton, Mass., has a 12-year-old daughter who is allergic to cashews and keeps EpiPens at home and school. Last year, Ms. Schulman’s out-of-pocket copayment for an EpiPen two-pack was $100. But because EpiPens may expire after a year, Ms. Shulman had to buy another two-pack to send along to her daughter’s camp this summer. Her cost for the same two pens was $400. “I called the insurance company and asked why it was so high and was told that, actually, it’s $700 total, and my co-pay is $400,” she said. For the first time in 10 years, Ms. Shulman said she briefly considered forgoing the purchase, but didn’t want to risk it. “It’s very wrong,” she said. “It’s gouging parents about their children’s lives. It’s not like letting them sniffle. It’s life or death.” Laurent Barr of Clark, N.J., said her copayment on EpiPens has risen from $141 to $245 in a year, and she will spend $735 this year for a supply of three EpiPen sets. Her 6-year-old daughter Leah is allergic to rice, tree nuts and mushrooms. “The price of EpiPens has been getting progressively worse over the years, but now it is just obscene,” Ms. Barr said. The price hike has caught the attention of Washington lawmakers. Senator Amy Klobuchar, Democrat of Minnesota, who has a daughter who carries an EpiPen, has called on the Senate Judiciary Committee and the Federal Trade Commission to review whether the price hikes violate any anti-competition rules. Last year, the drug maker Sanofi recalled a competing product, Auvi-Q, because it may not have been delivering the correct amount of epinephrine, leaving the EpiPen as the primary emergency treatment for severe allergic reactions. “This is a mainstream product that people carry, and it’s getting harder and harder for people to afford it,” said Senator Klobuchar. “It’s just another example of what we keep seeing, outrageous price increases when a monopoly situation ends up in a company’s lap.” Senator Chuck Grassley of Iowa called on Mylan to explain the price hikes, noting that they impose a burden on both parents and school districts, who often keep supplies of the pen at the ready. A petition to Congress protesting the price increase, called “Stop the EpiPen Price Gouging,” has emerged on social media. It has collected more than 48,000 signatures. Tonya Winders, president of the Allergy & Asthma Network, said her group is planning to work with other advocacy organizations to make the EpiPen a more universally-covered expense through a federal preventative services task force. She said most families are not feeling the impact of the EpiPen price hike because they have commercial insurance plans with lower copayments and deductibles. The families most affected by the price hike are those who don’t have insurance or those with high-deductible health plans, she said. “A lot of the families that are being hit with sticker shock are the ones that opted into high-deductible health plans in 2016,” Ms. Winders said. “We believe that Mylan should design a program specifically for those in that high-deductible rate.” In April, a pharmacist told Sarah Brown of Boulder, Colo., that her copayment on an EpiPen two-pack would be $585, even with a $100 coupon from Mylan. She said she had no choice but to take her chances and hold on to her expired EpiPens instead. “It was a gamble,” she said. In August, Ms. Brown’s family switched insurance plans so they could afford three packs for home, school and a grandmother’s house. Now, with the new policy and the Mylan coupon, she gets her pens at no charge. “The difference in insurance coverage means being able to afford them or not,” Ms. Brown said. mobile.nytimes.com/blogs/well/2016/08/22/epipen-price-rise-sparks-concern-for-allergy-sufferers/?_r=0&referer=https://news.google.com/
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Post by lakers on Aug 22, 2016 23:20:47 GMT -5
Two senators urge scrutiny of EpiPen price boost Two U.S. senators are raising concerns about massive price increases on a drug used under emergency conditions for food allergy reactions to see if they are justified. Photo: Mark Zaleski, AP, FR170793 AP EpiPen epinephrine auto-injector, a Mylan product Sen. Chuck Grassley, R-Iowa, has written the manufacturer, Mylan, asking for the reasons behind the price boosts for EpiPen, an epinephine auto-injector used to treat allergy reactions that has seen its price rise from $57 in 2007 to about $500 today. Sen. Amy Klobuchar, D-Minn., wants the Federal Trade Commission to take a look. "I am concerned that the substantial price increase could limit access to a much-needed medication,” Grassley wrote in the letter to Mylan CEO Heather Bresch. Since the drug is used for emergency treatment, it's not only patients who buy it, but public schools and other government institutions, Grassley says. “Many of the children who are prescribed EpiPens are covered by Medicaid and therefore the taxpayers are picking up the tab for this medication,” Grassley wrote. Klobuchar says her family is touched directly in hearing about the price increases on the drug. "Many Americans, including my own daughter, rely on this life-saving product to treat severe allergic reactions,” Klobuchar said in letter. “Although the antitrust laws do not prohibit price gouging, regardless of how unseemly it may be, they do prohibit the use of unreasonable restraints of trade to facilitate or protect a price increase." She called the price increase unjustified, putting "life-saving treatment out of reach to the consumers who need it most." There is no generic equivalent for EpiPen, and no direct competitor. Plus, consumers with high-deductible healthy insurance policies will have to pay more out of pocket to cover the high costs for the drug. Mylan issued a statement that did not specifically defend the price increases, but noted many consumers may be exposed to them now that they have been switched to a high-deductible policies. In the past, they might have only had a $25 co-pay and didn't know the full price of the drug. Now they must pick up the total tab. “More and more parents are complaining over the last month that the cost of EpiPens has gone through the roof, making it very difficult,” said David Namerow, a Fair Lawn, N.J., pediatrician. “They seem to be taking advantage of the most vulnerable kids with food allergies, and the parents have no alternative,” he said. Up to 6% of children have food allergies, with studies showing up to 18% of them having reactions after eating something at school that causes them to have a reaction, according to the federal Centers for Disease Control and Prevention. Nearly nine in 10 schools nationally had one or more students with food allergies. And since EpiPen expires after a year, schools and consumers must buy it annually. news.google.com/news/ampviewer?caurl=http%3A%2F%2Famp.usatoday.com%2Fstory%2F89129620%2F#pt0-825429I wouldn't be surprised if Mylan removes the TS Epi by you know what. They either do it now or pay up in later phases. Ray, the former Mylan CMO, knows what makes TS Epi ticks. If Mylan offers a low ball price of $2 * 478.05M = $956M cash for TS Epi, the board would be hard-pressed to decline knowing they have to raise fund later anyway at a lower price to finance Afrezza, and other TS drugs.
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Post by lakers on Jul 30, 2016 13:20:25 GMT -5
Second-quarter sales of Apidra® were up 3.2% to €93 million, reflecting lower sales in the U.S. (down 11.8% to €30 million), which were more than offset by the performance in Emerging Markets (up 27.8% to €20 million). First-half sales of Apidra® were stable at €178 million.
[Emerging Markets could be a good opps for Afrezza w/ good partners.]
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Post by lakers on Jul 30, 2016 13:11:07 GMT -5
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Post by lakers on Jul 27, 2016 1:18:50 GMT -5
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Post by lakers on Jul 21, 2016 17:55:52 GMT -5
Published Online: July 21, 2016 Mary Caffrey After hearing form supporters that included the chief medical officer of the American Diabetes Association (ADA) and a former Miss America, an FDA panel recommended Thursday that Dexcom’s G5 continuous glucose monitoring (CGM) system be approved for dosing insulin—a use that patients say are doing anyway. Adding a dosing indication to the Dexcom G5 would open the door for widespread patient and clinician training and education to help those with type 1 diabetes (T1D) or their parents, according to company officials and clinicians who spoke during the public hearing, held in Gaithersburg, Maryland. The meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel, which is a part of the Medical Devices Advisory Committee, voted in favor of all 3 questions put to it after a daylong hearing. Panel members voted 8-2 on the questions of whether the proposed new indication was safe and whether the benefits outweighed the risks. The panel voted 9-1 on the question of whether the CGM system was effective for its proposed new use. Recommendations now go to the full FDA. CGM uses a sensor and an algorithm fed to a receiver—or a smartphone—to take readings of blood glucose levels every 5 minutes around the clock and guide insulin dosing. Patients can set customized alerts to warn them when their blood glucose levels reach a high or a low level, and a built-in alarm goes off if a patient’s blood glucose reaches 55 mg/dL, a level that puts the person at risk of hypoglycemia and loss of cognitive function. Unlike self-monitoring of blood glucose (SMBG), Dexcom’s G5 system uses a combination of readings and trending arrows to tell patients if levels are rising or falling. If blood glucose levels are rapidly changing, that may indicate a different response than a SMBG tests that shows a reading above or below recommended levels. Dexcom's current approval requires SMBG for every insulin dose. Until recently, SMBG has been considered more accurate, but Dexcom, patients and several clinicians who spoke yesterday say the CGM technology has evolved to provide accuracy that is on nearly on par with a blood test and in many ways more useful. For these reasons, Dexcom began talks with FDA to discuss what information would be needed for a dosing indication. While the vast majority of those affected by the panel’s vote have T1D, an increasing number of persons with type 2 diabetes (T2D) could benefit from CGM, as the population ages and more seniors deal with the disease. As patients age, they are less likely to sense symptoms of hypo- or hyperglycemia, making CGM more critical. Because the technology is approved as “adjunctive” and not for dosing, Medicare considers it “precautionary,” and not necessary. Only a handful of patients have been able to appeal for coverage. This has been a point of great frustration for T1D patients; increasingly, they gain superior control with CGM and then lose access to the technology when they reach age 65. Brian Buckingham, MD, of Stanford, who presented information on Dexcom’s clinical utility, said CGM helps patients when they are most vulnerable: at night and when they are distracted. Most hypoglycemic events occur while patients are sleeping, when “finger testing is inadequate,” he said. - See more at: www.ajmc.com/newsroom/fda-panel-supports-using-cgm-for-insulin-dosing#sthash.tza31r2X.dpuf
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Post by lakers on Jul 21, 2016 17:45:28 GMT -5
www.massdevice.com/fda-panel-votes-favor-dexcom-g5-dosage-label-expansion/An FDA panel evaluating Dexcom’s G5 continuous glucose monitor seeking a non-adjuctive dosing claim voted in favor of the indication, with 8 votes for and 2 votes against. The panel voted on 3 separate questions during the evaluation. On whether or not there is reasonable assurance that the G5 is safe for its proposed indications for use, the panel returned 8 votes for and 2 against. The panel returned 9 votes in favor and 1 vote against when considering whether or not there is a reasonable assurance that the G5 is effective for the proposed indications, and 8 for and 2 against when asked whether the benefits of the G5’s proposed indications outweigh the risks, according to a Leerink Partners letter to investors. The company will have to wait to receive an official indication expansion from the FDA, but will do so now with the support of the panel vote. The new indication would allow the next-gen CGM to replace fingerstick blood glucose testing, as opposed to operating as complimentary to them. On Tuesday, the FDA released information for the panel as Dexcom sought the expanded indication for the G5 that would allow the next-gen CGM to replace fingerstick blood glucose testing, as opposed to operating as complimentary to them. The agency said that the accuracy of the G5 CGM was “close to, but not as good as, traditional self-monitoring blood glucose meters,” but touted that the G5 provides “contextual information and self-monitoring [that] self monitoring blood glucose meteres do not provide that may lead to users making more informed insulin dosing decisions,” according to the report. To support the use of the device under the new dosage labeling, Dexcom provided clinical data from trials of its G4 CGM, which uses an identical glucose sensor and algorithms. Reports from the device were found to be within 15% of standard blood sample readings in pediatric patients 81% of the time and for adult patients 86% of the time. The reports were within 20% in 91% and 93% of pediatric and adult patients respectively, and within 30% 96% and 98% of the time, respectively. “Significant numbers of Continuous Glucose Monitoring System users are believed to be currently using glucose values obtained from their Continuous Glucose Monitoring System devices (“off label” use) to make insulin dosing decisions. A significant barrier to these users making better, informed decisions using glucose data from their Dexcom G5 Continuous Glucose Monitoring System device is the labeling restriction currently in place that this device is only to be used adjunctively,” the FDA wrote in the prepared panel information.
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Post by lakers on Jul 12, 2016 18:58:26 GMT -5
surplus.value • 3 hours ago 14users liked this postsusers disliked this posts0Reply MNKD presentation today at Cantor Mike presented (dont know what happened to Matt?) -Funds until Q1 2017 -10 million /month burn rate -7-8 out of 10 patients are being approved by insurance .. very positive -Coverage by Aetna and Express already , CVS and UNITED coming along, Medicare slower and will be about 1.5 years before medicare is fully present (process takes much longer) - are targeting 3/4 of diabetes market -protocols for pediatric should be ready before end of 2016 may facilitate use in externals markets as an inroad. - use two of the studies presented at ADA to push for a label change -July 25 or earlier MNKD's own product will be distributing (and 100% goes to MNKD) Some issue with Sanofi's supply which has 6 month expiry (DEC) so some issue with pharmacies stocking it. Will speak to Sanofi and also MNKDs own supply will be now used. -Spirometry not a problem , being taken care of . -- MNKD own patient reimbursement program launching Aug 1 and is well organized (online) "MNKD cares" -Late August sample packs for new adopters and will have sufficient supply dosages to offset any problems with lasting for early patients - 180 count titration packs to also deal with new patients running out 60's of 4, 8, 12 (180 total) and 90 count packs of 8 and 12 -Price renegotiation revisited as demand and sales increase. -Not looking for partner in US -working on foreign deal but good deal difficult until US sales ramp up. - should see script numbers bottom out in july and start to increase in next few months August and onwards -Controlling costs - still pursuing Technosphere applications ( 3 main ones already discussed previously ) which are not costing much now and seeking partners for these - End of year milestone payment coming but cant discuss due to NDA Thats all I managed to write down. Mike knows what hes doing. Very confident. Finally MNKD has someone on the ball. Also from memory. -ADA went really well. MNKD booth was solidly busy for 3 days. Countered the false assumption that MNKD was disappearing from the market - Mike said something about speaker programs (something to do with widening awareness of Afrezza in the general market. -Mike is not worried about coverage but continues to be in contact and discussion withpayers/insurance etc. _ Mike is keeping his ear close to the ground keeping in touch with sales personell, nurses etc. finance.yahoo.com/mbview/threadview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1468354989952-0afbea59-b93c-40e7-9690-0bd4a9034292&tls=la%2Cd%2C2%2C3
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Post by lakers on Jun 29, 2016 17:55:33 GMT -5
www.freshpatents.com/-dt20160623ptan20160175079.phpInsufflation apparatus and methods An insufflation apparatus and methods for using same are disclosed. The apparatus is equipped with an interactive system for administering reproducible intratracheal aerosols in a consistent automated manner. The insufflation system is useful, in particular for use with experimental animals, including mice and rats and also for treating small animals via the pulmonary route in veterinary medicinal practice. Examples of drugs for lung delivery include, vasodilators, surfactants, chemotherapeutic agents, or vaccines for flu, or other respiratory illnesses for the treatment of diseases, including, asthma, COPD, cystic fibrosis, and pulmonary infections. Pulmonary administration enables rapid treatment of these chronic and acute conditions. Drug formulations for treating pulmonary diseases such as asthma are available by several methods, including, using nebulizers such as treatment with PULMOZYME®, using metered-dose inhalers such as SYMBICORT®, and dry powder inhalers such as ADVAIR DISKUS®, PULMICORT FLEXHALER®. Other types of treatments, including biologics such as nucleotides drugs in genetic therapy have been delivered to the lungs, for example, for gene therapy of cystic fibrosis, where retroviral vectors expressing an effective adenosine deaminase are administered to the lungs. Currently, formulations for treating systemic disease using biologic products are available primarily through injectable compositions. Dry powder compositions for pulmonary inhalation and systemic delivery of insulin have been used, including EXUBERA®, and AFREZZA®.
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Post by lakers on Jun 19, 2016 12:08:15 GMT -5
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Post by lakers on Jun 19, 2016 4:24:30 GMT -5
I got home from work today and pulled the property records from King County (Seattle WA) for the address Receptor Life Sciences is registered to (2578 Constance DR W, Seattle, 98199). www.sos.wa.gov/corps/search_detail.aspx?ubi=603568334The owner of this residence is Traci Carman (CFO of EMP museum founded by Paul Allen and listed director of Receptor Life Sciences) In this 2012 report Greg Wesner, the attorney listed as Receptor Life Science's director, is listed as a supporter of the EMP museum, founded (and funded) by Paul Allen (CFO Traci Carman) Gregory Wesner's LinkedIn summary says that he has served pro bono as counsel to the Experience Music Project (EMP) in its community outreach efforts (Founded by Paul Allen, CFO Traci Carman) A company called ELC DEVELOPMENT lists both Paul Allen and Traci Carman as directors. Mr. Wesner specializes in intellectual property law. m.reddit.com/r/wallstreetbets/comments/4b6b5l/i_dont_mean_to_be_annoying_a_very_brief_update_to/
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Post by lakers on Jun 3, 2016 23:32:03 GMT -5
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