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Post by prvs on Aug 22, 2016 17:41:19 GMT -5
Do you see the black bar at the bottom? Based on what was discussed at the 2Q16 earnings call, I believe that the company has made the "Go" decision. So they could, in fact, be negotiating with a pharmaceutical company or companies to evaluate which provides the best business opportunity.
You're right about weighing the need for secrecy against the need to prop up the company's image, but Matt spoke about this subject of negotiations over a year ago. Management will not divulge that they are in specific talks or provide any kind of timeline for such negotiations until they are at the signing stage, because pre-announcing that you're in talks will give the other party leverage. Based on the IGXT model, a small phase 1 study of 8 people is needed to determine if the new form (inhaled) of epinephrine is bioequivalent to the injected form now on the market. A phase 2a study is when a partner comes in who's willing to pay for the study in exchange for commercialization rights. IGXT is doing that with Montelukast right now. If there had been a P1 study, I think they would have announce it? Or is that not considered eventful enough?
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Post by flatrock on Aug 22, 2016 19:13:54 GMT -5
Do you see the black bar at the bottom? Based on what was discussed at the 2Q16 earnings call, I believe that the company has made the "Go" decision. So they could, in fact, be negotiating with a pharmaceutical company or companies to evaluate which provides the best business opportunity.
You're right about weighing the need for secrecy against the need to prop up the company's image, but Matt spoke about this subject of negotiations over a year ago. Management will not divulge that they are in specific talks or provide any kind of timeline for such negotiations until they are at the signing stage, because pre-announcing that you're in talks will give the other party leverage. Based on the IGXT model, a small phase 1 study of 8 people is needed to determine if the new form (inhaled) of epinephrine is bioequivalent to the injected form now on the market. A phase 2a study is when a partner comes in who's willing to pay for the study in exchange for commercialization rights. IGXT is doing that with Montelukast right now. If there had been a P1 study, I think they would have announce it? Or is that not considered eventful enough? What is the "IND enabling" phase? Why does it take nine months?
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Post by nylefty on Aug 22, 2016 19:33:06 GMT -5
Based on the IGXT model, a small phase 1 study of 8 people is needed to determine if the new form (inhaled) of epinephrine is bioequivalent to the injected form now on the market. A phase 2a study is when a partner comes in who's willing to pay for the study in exchange for commercialization rights. IGXT is doing that with Montelukast right now. If there had been a P1 study, I think they would have announce it? Or is that not considered eventful enough? What is the "IND enabling" phase? Why does it take nine months? Google is your friend. www.pharmanest.com/images/IND-Enabling_Technologies.pdf
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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 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 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 flatrock on Aug 23, 2016 8:18:17 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. That part about no generic equivalent isn't exactly correct. I posted under another thread: adrenaclickgeneric USP epinephrin injectorThe last one has a coupon available for it as well. The first one costs $142 for a two pen set at Walmart.
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Post by thekindaguyiyam on Aug 23, 2016 11:16:20 GMT -5
Senator calls for investigations into Mylan's 400% EpiPen price increases www.fiercepharma.com/pharma/senator-calls-for-investigations-into-mylan-s-400-epipen-price-increasesBack in June, Wells Fargo’s David Maris highlighted several price hikes Mylan had implemented in 2016, calling them “beacons for scrutiny” in the current drug pricing climate. Now, sure enough, the company is facing the prospect of investigations following years of price increases on its big-selling EpiPen. Citing a 400% price increase on the epinephrine injection since 2009, Sen. Amy Klobuchar (D-MN) has called for the Senate Judiciary Committee and Federal Trade Commission to investigate the pricing practices. Sen. Chuck Grassley (R-IA) is seeking info on the topic, and Sen. Bernie Sanders (I-VT), often an outspoken pharma critic, tweeted that "There's no reason an EpiPen, which costs Mylan just a few dollars to make, should cost families more than $600." In a statement, Mylan said “ensuring access to epinephrine--the only first-line treatment for anaphylaxis--is a core part of our mission.” The company stressed that nearly 80% of commercially insured patients on the company’s patient assistance program got the med at no cost in 2015, and its school access program has distributed 700,000 injectors to 65,000 schools since 2012. According to Klobuchar, an EpiPen two-pack cost patients $100 dollars in 2009, but in 2016 the price is $500 or, for some patients, $600. In a recent note, Maris said Wells Fargo had spoken to a pharmacist who had patients unable to afford the med. "This outrageous increase in the price of EpiPens is occurring at the same time that Mylan Pharmaceutical is exploiting a monopoly market advantage that has fallen into its lap,” Klobuchar said in a statement, citing stumbles by Sanofi, which suspended its Auvi-Q rival after a recall, and Teva, which has been struggling to get a competitor to market. In March, the FDA rejected a generic competitor from Teva, due to “certain major deficiencies,” a setback Teva said would cause “significant” delays. And in November, Sanofi ran into injector problems with its Auvi-Q competition, resulting in a nixed marketing deal and an uncertain future for that injector. Follow Richard Blumenthal ✔ @senblumenthal I'm demanding that #Mylan lower the price of its #EpiPen for all Americans that rely on it for their health & safety ow.ly/gQLD303tXkE 2:27 PM - 22 Aug 2016 46 46 Retweets 81 81 likes But the scrutiny shouldn’t come as a surprise, given developments in pharma’s pricing climate over the last year. After Turing Pharmaceuticals and Valeant Pharmaceuticals kicked off a pricing firestorm, public and political attention on pharma pricing has spread industrywide, with other companies--including Pfizer, Allergan, Amphastar and Endo--also falling into the spotlight. And EpiPen isn’t the only product on which Mylan has faced questions. Back in June, Senators asked providers of naloxone--Pfizer, Mylan, Amphastar ($AMPH), Adapt Pharma and Kaleo--to explain price increases on that med, which is used to reverse the effects of opioids. - here's Klobuchar's statement - more from Klobuchar calling for an FTC investigation - read Mylan's release - and Grassley's statement Related Articles: Pricing trouble ahead for Mylan? Analyst calls recent hikes 'beacons for scrutiny' FDA swats down Teva's EpiPen copy, putting Mylan in cruise control Senate committee takes Pfizer, Mylan and others to task over naloxone price increases Drug price increases lower so far in 2016: Analysts
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Post by kc on Aug 23, 2016 14:20:46 GMT -5
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Post by kc on Aug 23, 2016 14:45:30 GMT -5
The Market for the Epi-Pen is bigger than I would have thought. This article from the NY post puts into prospective how important the Epi-Pen is to the user.
nypost.com/2016/08/22/parents-are-getting-screwed-by-the-cost-of-epipens/
It’s all about figuring out how many EpiPens we need, ” says Suzie Fromer, 43, whose son has severe allergies.
“I have two in my purse,
my 10-year-old has two in his backpack,
there are two with the school nurse, and then
two at home as well. You need to have them in arm’s reach,”
adds the Irvington, NY, resident, who is the co-founder of FoodAllergyNY, an allergy-research clearinghouse
“We had to get three refills this fall, and each one cost $428.27. These will all expire in February, when we’ll have to get them again. And this is with insurance,” says Samantha Marino, 40, of Hartsdale, NY, whose 4-year-old son, Ben, has a severe nut allergy. Marino leads the Westchester No Nuts Moms Group and says members have been dismayed by their pharmacy bills. “We’re fortunate enough to be able to afford to pay out of pocket, but a $2,500 annual outlay is ridiculous.”
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Post by afrezzamiracle on Aug 23, 2016 15:01:54 GMT -5
Another Epi Pen story in USA Today: www.usatoday.com/story/news/politics/2016/08/23/epipens-steady-price-increases-masked-until-deductibles-rose/89123786/MNKD is missing a GOLDEN OPPORTUNITY right now. There is a tremendous market need for a reasonably priced Technosphere based Epi product. Now it's become political football as well, with intolerable 600% price increases from Mylan. For once, can we strike while the iron is HOT?! Enter the public debate/discussion, partner up with a heavyweight, get political/FDA support, get free media hype, and execute for once! We have this unbelievable technology but after all these years our lack of execution is about to send us into bankruptcy. It's such a freaking waste...
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Post by nylefty on Aug 23, 2016 15:54:45 GMT -5
Another Epi Pen story in USA Today: www.usatoday.com/story/news/politics/2016/08/23/epipens-steady-price-increases-masked-until-deductibles-rose/89123786/MNKD is missing a GOLDEN OPPORTUNITY right now. There is a tremendous market need for a reasonably priced Technosphere based Epi product. Now it's become political football as well, with intolerable 600% price increases from Mylan. For once, can we strike while the iron is HOT?! Enter the public debate/discussion, partner up with a heavyweight, get political/FDA support, get free media hype, and execute for once! We have this unbelievable technology but after all these years our lack of execution is about to send us into bankruptcy. It's such a freaking waste... So MannKind should wave a magic wand and make the FDA disappear, leaving it free to put a Technosphere-based EPI on the market tomorrow, without all those pesky trials, etc. As for possible partners, how do you counter the argument that since Afrezza has so far been a flop any other use of Technosphere would flop too. Seems to me Afrezza has to redeem itself before anybody else will want to touch Technosphere. That said, I continue to believe that eventually both Afrezza and Technosphere will be success stories, with the emphasis on eventually.
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Post by afrezzamiracle on Aug 23, 2016 16:10:56 GMT -5
Get the powerful Senators behind us to pressure the FDA to fast track Technosphere Epi. Get the product to market ASAP with reasonable profit margins, but far below Mylan. Maximize the public relations to get free exposure for AFREZZA while we're at it. Everyone wins, except price gouging Mylan.
BTW we better be well underway in proving that AFREZZA is NOT a flop, or we won't be around long enough to worry about it. There is NO TOMORROW, only today, and we absolutely must execute like our life depends on it on all fronts.
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Post by Deleted on Aug 23, 2016 16:13:05 GMT -5
Get the powerful Senators behind us to pressure the FDA to fast track Technosphere Epi. Get the product to market ASAP with reasonable profit margins, but far below Mylan. Maximize the public relations to get free exposure for AFREZZA while we're at it. Everyone wins, except price gouging Mylan. BTW we better be well underway in proving that AFREZZA is NOT a flop, or we won't be around long enough to worry about it. There is NO TOMORROW, only today, and we absolutely must execute like our life depends on it on all fronts. Email management and BOD. More effective than people on this board
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Post by afrezzamiracle on Aug 23, 2016 16:18:20 GMT -5
The Chief Commercial Officer is a member of this board. If Senators want to make this their "pet project" the time to be in their ear with a solution is RIGHT NOW, not 6 months down the road. Hopefully this was immediately apparent to management before I mentioned it!
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