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Post by tonyz on Oct 10, 2015 13:41:51 GMT -5
Just my opinion, but I think the battle for afrezza formulary approval is the one that, if successful, will ultimately open the way for the other TS applications. It appears that it can be demonstrated that afrezza is superior to other insulin delivery methods, not just more convenient, but with much better long term health consequences and quality of life. If that can be proven to the health community and in turn the insurance companies, everything will finally fall in place. The truth is that until that happens MNKD remains a speculative stock and I suspect several people on this board (including myself) probably have more shares they than they should. That said, I think the potential reward for holding the stock far outweighs the potential loss from this price. Which is also probably in line with the thinking of most of the other longs on this board.
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Post by mnholdem on Oct 10, 2015 14:58:30 GMT -5
I don't have enough shares. But I am working on that...
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Post by kball on Oct 10, 2015 15:12:31 GMT -5
I'm not going anywhere because I don't like losing half my value. If I lose it all, so be it. I'm married to this stock because I want to see it succeed. I want a paradigm shift in medicine because I'll be practicing in a couple years. People don't consider that the reason not much comes out of MNKD is because they have nothing good to report. No news is better than bad news. We're not there yet and this will still be a blockbuster someday is the best ammunition they've got. The few kernels they've released, "embarrassment of riches" and Hakan s late September comment have yet to materialize or were shot down from the horse's mouth. Me too. Separate bedrooms now since a few months ago. |
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Post by lakers on Oct 10, 2015 18:33:02 GMT -5
Microparticles Deliver Insulin Through The Lungs A model of the inactive form of insulin that is stored in the pancreas. Six insulin molecules assemble as a hexamer, held together by two central zinc atoms (blue spheres). A model of the inactive form of insulin that is stored in the pancreas. Six insulin molecules assemble as a hexamer, held together by two central zinc atoms (blue spheres). Credit: Insulin Inhalers have allowed people to self-administer drugs to treat asthma, cystic fibrosis, and other lung diseases. This drug delivery route is now being used to treat systemic diseases as well. To treat type 2 diabetes, MannKind Corp. has developed inhalable microparticles comprising fumaryl diketopiperazine and insulin (US 20150031609). The diketopiperazine forms hydrogen bonds with the active monomeric form of insulin, stabilizing the peptide, so it can be delivered into the lungs. The researchers found that insulin levels in blood peaked within 12–15 minutes of patients’ inhaling the particles, which is faster than when patients inject insulin. The Food & Drug Administration approved the inhaled insulin in 2014, and MannKind currently markets the product under the trade name Afrezza. Andrea Leone-Bay, vice president of pharmaceutical development at MannKind, tells C&EN that the same technology can be used to deliver other peptides and small molecules with a mass of less than 100 kDa. cen.acs.org/articles/93/i30/Patent-Picks-Insulin-Drug-Delivery.html#1 |
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Post by ricguy on Oct 10, 2015 20:19:09 GMT -5
I'm not going anywhere because I don't like losing half my value. If I lose it all, so be it. I'm married to this stock because I want to see it succeed. I want a paradigm shift in medicine because I'll be practicing in a couple years. People don't consider that the reason not much comes out of MNKD is because they have nothing good to report. No news is better than bad news. We're not there yet and this will still be a blockbuster someday is the best ammunition they've got. The few kernels they've released, "embarrassment of riches" and Hakan s late September comment have yet to materialize or were shot down from the horse's mouth. Me too.Separate bedrooms now since a few months ago. ME 3. Getting divorced next May if this terd doesn't turn around. |
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Post by suebeeee1 on Oct 10, 2015 21:31:33 GMT -5
Zofran sells for less than $0.50/pill and I can't remember how much imitrex is... I think it was about $15 for a 9 pack? I really wish I would have considered insurance more when I was doing my DD. I don't really think TS will have much success on the already generic drugs. Not many insurance companies will pay for a reformulated generic. Even if they do, will it be worth it to the patient to spend $30 - $40+ for their brand copay as opposed to a $5/$10 generic copay for the same medication, just administered more quickly? The only way MNKD can survive on the generic market is high volume and low cost. In theory, nearly any drug would be better inhaled than ingested. So much metabolism occurs before the active ingredients get to the gut for absorption. But will they be able to monopolize an entire market with the dreamboat? I know I've been pessimistic lately - sorry to the longs that it offends - but can anyone explain how they see this company making money in the next 2 years off of TS? They all seem like niche products. Pain seems to me to be the only money maker. People will pay for better pain control, but I fear not much else. And even then the increase in cost has to be reasonable. If you have ever suffered from intractable vomiting, you'd know how important it is to have some sort of delivery system other than a pill. Generally for people who are vomiting so severely, injections are the only option. Additionally, since most people suffering from vomiting are not like diabetics who have to inject several times daily and learn how to inject themselves, they need to visit their doctors for the injections or enter a hospital for I.V delivery. Add those costs to the cost of the "generic" med and suddenly, a $10 inhalable is a very small price to pay. |
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Post by stevil on Oct 10, 2015 23:18:03 GMT -5
I don't disagree with anything you said. You seem to have missed the thesis of my argument so I'll try to reiterate.
It would be wonderful for every one of these drugs to be made for TS. They all have practical purposes. They all would work better than what is currently out there.
Making money off of these generics is unlikely for 2 reasons (among others probably):
1. Insurance won't cover them.
If they do, they'll require a prior authorization or will charge a brand copay. PAs only make sense for chronic users. However, most people I met in the pharmacy, sans chemo patients, needed an ODT- oral dissolvable tablet- for their Zofran, and right away. It's not a tablet that needs to be swallowed because it will dissolve in their mouth. 90% of the scripts were for acute episodes that wouldn't have made sense to wait for a P.A. because they would be fine within the next couple days if not sooner.
2. Patient willingness to pay more money for the same medication.
This seems to be the one you're referencing. $10 would be a steal for a brand copay. I have not seen many insurance companies that offer that as a brand copay. Typically, Tier 2 was $25/$40, Tier 3 $50/$75. Something like that. Very rarely was the brand copay less than 2.5 times as much as the generic copay. While there are some extenuating circumstances that would justify paying that much a premium for a product, what you essentially described is a niche product. It's extremely hard to make money off of a niche product unless you charge hundreds to thousands of dollars per dose, depending on how much demand their is for that niche. That won't fly here.
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Post by nylefty on Oct 11, 2015 14:22:07 GMT -5
ME 3. Getting divorced next May if this terd doesn't turn around. I stopped visiting the Yahoo board because of posts like the above. Sorry to see terms like "terd" being used here. |
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Post by kball on Oct 11, 2015 15:17:51 GMT -5
I stopped visiting the Yahoo board because of posts like the above. Sorry to see terms like "terd" being used here. Not my quote Lefty I said we were sleeping in separate bedrooms. For The Record. In case you wanted to quote me correctly |
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Post by suebeeee1 on Oct 11, 2015 15:29:23 GMT -5
Not my quote Lefty I said we were sleeping in separate bedrooms. For The Record. In case you wanted to quote me correctly Sorry to hear that Kball. And when this turns around (whenever), what exactly is going to be your reward? Suebeeee1 (Not sleeping in separate rooms YET, but hearing about my investment daily) |
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Post by nylefty on Oct 11, 2015 16:16:45 GMT -5
I stopped visiting the Yahoo board because of posts like the above. Sorry to see terms like "terd" being used here. Not my quote Lefty I said we were sleeping in separate bedrooms. For The Record. In case you wanted to quote me correctly I correctly quoted ricguy. The confusion was caused by the fact that if you delete language you are NOT responding to, there seems to be no way to delete the name of the author of that language. |
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Post by lakers on Oct 14, 2015 18:51:40 GMT -5
Sildenafil and tadalafil. Sildenafil (Revatio, Viagra) and tadalafil ( Cialis, Adcirca) are sometimes used to treat pulmonary hypertension. These drugs work by opening the blood vessels in the lungs to allow blood to flow through more easily. Side effects include upset stomach, dizziness and vision problems. According to a new market report published by Transparency Market Research “Pulmonary Arterial Hypertension (PAH) Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020,” the global PAH market was valued at USD 4.04 billion in 2013 and is expected to grow at a CAGR of 2.3% from 2014 to 2020, to reach an estimated value of USD 5.19 billion in 2020. Browse the full Pulmonary Arterial Hypertension (PAH) Market (Prostacyclin and Prostacyclin Analogs, ERAs, PDE-5 Inhibitors, sGC Stimulators and Selexipag) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 – 2020 report at www.transparencymarketresearch.com/pulmonary-arterial-hypertension-therapeutics.html Pulmonary arterial hypertension (PAH) is a medical condition, characterized by restricted blood flow through the pulmonary arteries, which leads to a progressive increase in pulmonary vascular resistance and subsequently right heart failure. PAH is one of the five groups of pulmonary hypertension, classified by the World Health Organization (WHO). PAH occurs, when the pulmonary arteries become narrowed, thickened, or blocked. The advanced therapy to treat PAH includes prostacyclin and prostacyclin analogs, endothelin receptor antagonists (ERAs), phosphodiesterase-5 (PDE-5) inhibitors, and soluble guanylate cyclase (sGC) stimulators. This advanced therapy is directed towards PAH itself, and not at the underlying cause of PAH. In addition to the aforementioned classes of drugs, physicians also prescribe drugs such as calcium channel blockers, diuretics, digoxin and anticoagulants to patients with PAH. Based on the commercially-available drug classes, to treat PAH, the global PAH market has been segmented into prostacyclin and prostacyclin analogs, endothelin receptor antagonists (ERAs), phosphodiesterase-5 (PDE-5) inhibitors, and soluble guanylate cyclase (sGC) stimulators. Prostacyclin and prostacyclin analogs were the first medications approved by the U.S. FDA for the treatment of PAH. Currently, epoprostenol (Flolan and Veletri), treprostinil (Remodulin, Tyvaso and Orenitram), and iloprost (Ventavis) are the three drugs under this category, which are widely used to treat patients with PAH. A new drug called Uptravi (selexipag), which is a selective IP prostacyclin receptor agonist, is expected to be launched in 2016. This new drug is likely to drive growth of the prostacyclin and prostacyclin analogs market during the forecast period from 2014 to 2020. Endothelin receptor antagonists (ERAs) that inhibit the interaction between endothelin and endothelin receptors have emerged as one of the mainstays in the treatment of PAH. Tracleer (bosentan) is the first U.S. FDA approved ERA that is being used to treat PAH. Letairis/Volibris (ambrisentan) and Opsumit (macitentan) are the other approved ERAs for treating PAH. Of these, Opsumit was approved by the U.S. FDA and the European Commission in December 2013. Opsumit is expected to emerge as the most selling PAH drug by the end of 2020. Tracleer is set to go off-patent in the U.S. and Europe in 2015 and 2017, respectively. Patent expiry of Tracleer is likely to cause a huge set back in growth of the ERAs market during the forecast period from 2014 to 2020. Revatio (sildenafil) from Pfizer, Inc. and Adcirca (tadalafil) from Eli Lilly/United Therapeutics Corporation are the two U.S. FDA approved PDE-5 inhibitors that are used to treat PAH. Adempas (riociguat) is the only approved sGC stimulator for the treatment of PAH. Adempas is designed to treat PAH by stimulating the nitric oxide receptor sGC, which induces vasodilation. Adempas was first approved by the U.S. FDA in October 2013. During the forecast period between 2014 and 2020, riociguat would face stiff competition from drugs such as macitentan and treprostinil (extended release tablet), as they all are meant for oral administration. The novel mode of action of riociguat would also play a key role in driving growth of this segment during the forecast period. The global pulmonary arterial hypertension (PAH) market was dominated by players such as Actelion Pharmaceuticals, Ltd., Gilead Sciences, Inc., GlaxoSmithKline plc, Pfizer, Inc., and United Therapeutics Corporation in 2013. Actelion Pharmaceuticals, Ltd. accounted for the largest share of the overall PAH market in 2013, as one of its products, Tracleer (bosentan), was the bestselling PAH drug in 2013. During the forecast period from 2014 to 2020, Bayer HealthCare, which recently launched a new drug Adempas (riociguat), is likely to witness substantial growth in the PAH space. Arena Pharmaceuticals, Inc., Dong-A ST Co., Ltd., Reata Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novartis International AG, and Aires Pharmaceuticals, Inc. are some major companies with PAH drugs in their clinical pipeline.The global PAH market is segmented as follows: Global Pulmonary Arterial Hypertension Market, by Drug Class Prostacyclin and Prostacyclin Analogs Endothelin Receptor Antagonists (ERAs) Phosphodiesterase-5 (PDE-5) Inhibitors Soluble Guanylate Cyclase (sGC) Stimulators 8:00 Tools on line now. Important to be putting information out there; mentioned the Afrezza Coach program. Referring to treatment of diabetes and medicine in general, Matt said, "Making a fundamental change is difficult." Touched on TS platform; consider it the future of the company as the basis for new products. Matt now regrets “embarrassment of riches” comment. He had meant that TS could be used for many API / drug entities and the future was wide open for other TS / drug combinations. 9:00 Looking at drugs which take advantage of TS features besides just eliminating the injection. Not practical to develop new chemical entities so working for next product to be a known drug. Occasionally look at NCE’s which are nice to look at but it would be a 10 year process. 10:00 Spent a lot of time and money on the consulting process to select 2 new applications / drug candidates. First indication would be pulmonary hypertension. This is a serious effort on the company’s behalf. The R&D activities are fully staffed and preclinical work has been/is being done. We can look forward to hearing more news about this soon but not at the moment. Licensing tech to other companies - have to be careful not create competitors to ourselves. Read more: mnkd.proboards.com/thread/3641/mnkd-present-aegis-capital#ixzz3oab04N3x A partner owning a commercial PAH drug must have signed NDA w/ Mnkd to develop TS-based PAH. No wonder PAH was fast tracked ahead of Pain Med. Hakan alluded to this. GSK owns Flolan, a leading PAH - inhaled TS-based Flolan. PFizer owns Viagra - Inhaled TS-based Viagra.In 2003, Eli Lilly introduced Cialis (tadalafil), a competitor to Pfizer's blockbuster Viagra for erectile dysfunction. Cialis maintains an active period of 36 hours, causing it sometimes to be dubbed the "weekend pill". Cialis was developed in a partnership with biotechnology company Icos Corporation - Inhaled TS-based Cialis. |
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Post by stevil on Oct 14, 2015 19:18:29 GMT -5
I'd heard Al wouldn't do Viagra because it was too dangerous to dilate the blood vessels through an inhalant. But if they could somehow do it, THAT would be our blockbuster for sure. This would fund every single other application we could dream of. I think the protocol now calls for an hour before sexual activity, unless you're on the 5mg once daily Cialis. Don't know much about that one. But if you could take a puff and then get frisky immediately, MNKD would be swimming in cash.
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Post by liane on Oct 14, 2015 19:28:58 GMT -5
Al definitely has said Viagra on the Technoshere platform might cause a dangerous drop in blood pressure, but the dosing of sildenifil for PAH is only 20 mg vs 50mg for ED. Still - no way of knowing the effect without studies.
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Post by traderdennis on Oct 14, 2015 21:41:52 GMT -5
Al definitely has said Viagra on the Technoshere platform might cause a dangerous drop in blood pressure, but the dosing of <gs id="263bd6bc-9db9-4657-a53d-a056f5308daa" ginger_software_uiphraseguid="4fe49c2e-85bd-4418-8745-4728d3c33f77" class="GINGER_SOFTWARE_mark">sildenifil</gs> for PAH is only 20 mg <gs id="68df0e6c-59f2-4e8e-bf25-a9650feb2027" ginger_software_uiphraseguid="4fe49c2e-85bd-4418-8745-4728d3c33f77" class="GINGER_SOFTWARE_mark">vs</gs> 50mg for ED. Still - no way of knowing the effect without studies. If this was possible, I believe Phizer or a different ED provider would of been our <gs id="e3d34129-a05c-449a-b093-5af63971e1bf" ginger_software_uiphraseguid="65c4ee44-e7bc-410f-9026-b675271a13f2" class="GINGER_SOFTWARE_mark">partner</gs>. Just cutting down the 1-2 hour wait <gs id="d55d62a1-721a-4683-891d-ba24c2d8bc8e" ginger_software_uiphraseguid="263ade2a-0a12-4442-b6f3-fa1987ec30f6" class="GINGER_SOFTWARE_mark">to</gs> 15 minutes would of been a huge selling point and possible new patent. Plus the Ed makers have diabetic portfolios. |
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