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Post by mnkdfann on Jun 6, 2019 13:05:02 GMT -5
It is tricky to guess what Afrezza will cost because 1U of Afrezza is not the same as 1U of injected RAI, but if CMED does a unit for unit conversion, 1000 units of insulin will have a maximum pharmacy price of around $24. That $24 has to cover MNKD's selling price, cost of freight and duties, Biomm's costs and a distributor profit. Given typical expense and distributor profit rates in the industry, I would expect MNKD to receive about two-thirds of that or roughly $16 for 1000 units. If CMED allows a premium for the inhaler, the way they do for the Fiasp injector pen, the price could be up to 20% higher. I assume the exact figure is unknown to us but, in your estimation, what do you think Mannkind receives for 1000 units in the U.S.?
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Post by mnkdfann on Jun 6, 2019 2:04:31 GMT -5
The RIO TImes mentioned it doesn't require refrigeration! Wake up FDA! This is a huge differentiating factor that needs to be recognized. I'm not a diabetic, but is refrigeration really a big deal for most users of insulin? I just looked at the instructions for Humalog (Lispro), and they say to store "opened vials in the refrigerator or at room temperature below 86°F (30°C) for up to 28 days". That doesn't seem very onerous to me. Unless you live in a very hot climate with no air conditioning. I assume a vial is used up in far fewer than 28 days.
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Post by mnkdfann on Jun 6, 2019 1:57:21 GMT -5
The RIO TImes mentioned it doesn't require refrigeration! Wake up FDA! This is a huge differentiating factor that needs to be recognized. You have to wonder what MNKD said/did to convince Anvisa that it doesn’t require refrigeration. Of course this information could be coming from anywhere at the moment, and until we see the label, we won’t know what is reality. I'm not sure we know that Anvisa believes that, given what the article says. The statement is made with no precise attribution (just to unknown 'experts'). It may have come from the Biomm CEO. Or just be something the reporter read on the web, as part of the background for the article.
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Post by mnkdfann on Jun 5, 2019 23:57:15 GMT -5
10% - 1.5 million T1D in Brazil ! I reiterate my 5% market share for Afrezza I hope so, but without pricing information, predictions are premature. There are no guarantees Afrezza with be competitive or have enough resources will be allocated to train docs. There are also the statements: "In the case of type 2 diabetics, Afrezza would be recommended only for patients who are unable to control blood glucose by only using oral medication" and "most type 2 diabetics are treated with pills and not with insulin" to be taken into account.
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Post by mnkdfann on Jun 5, 2019 22:30:09 GMT -5
riotimesonline.com/brazil-news/brazil/anvisa-approves-first-inhaled-insulin-in-brazil/[More at the link.] According to experts, although it represents an alternative for treating diabetes and a benefit in quality of life by reducing the number of injections, Afrezza has limitations. It is unable to replace all daily insulin applications, it has a limited range of dosage and is unsuitable for patients with lung conditions and those under eighteen years of age. On the other hand, it is easier to carry and store as it does not require refrigeration and may reduce the number of needle pricks that the patient has to undergo daily. Inhaled insulin may only replace fast-acting or ultra-fast insulin applications, also called “bolus”. This type of insulin is typically used before each meal when the body needs a larger amount to compensate for sugar intake. The other type of insulin, “basal”, of slower action, is generally used only once daily and cannot be replaced by the inhaled drug, as explained by Lívia Porto, an endocrinologist at the Centro Especializado em Obesidade e Diabetes of Hospital Alemão Oswaldo Cruz, which specializes in treating obesity and diabetes. “If a diabetic patient is treated using this basal-bolus therapy, he or she typically takes at least four injections a day: one basal and three boluses, for breakfast, lunch, and dinner. Switching to an inhaler would reduce it from four daily doses to one. It would be a gain in quality of life, although it would not entirely replace the injection”, says the doctor. For Heraldo Marchezini, CEO of Biomm, the company responsible for product distribution in Brazil, Afrezza’s ease of handling and use represents an improvement in the quality of life of patients. “At mealtimes, the patient often needs to use insulin in a social environment outside the home. The inhalable solution can be faster and more discreet. The inhaler fits in the palm of your hand. It’s a great innovation in terms of use,” he says. He asserts that the product is suitable for type 1 and 2 diabetes patients. Nevertheless, considering that most type 2 diabetics are treated with pills and not with insulin, the main beneficiaries of the new product would be type 1 diabetic patients, who must obligatorily be treated with insulin. “In the case of type 2 diabetics, Afrezza would be recommended only for patients who are unable to control blood glucose by only using oral medication,” explains endocrinologist Freddy Eliaschewitz, scientific advisor to the Brazilian Society of Diabetes and director of the Clinical Research Center CPclin, a Brazilian institution that participated in studies on inhaled insulin. According to the specialist, of the approximately 15 million Brazilians suffering from diabetes, it is estimated that 10 percent suffer from type 1 diabetes and 90 percent from type 2.
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Post by mnkdfann on Jun 5, 2019 18:29:46 GMT -5
So mnkd finally received approval in Brazil. What is in store for the next six months as we reach the half way point in the year? (I am only including items that have a reasonable of occurring) The Good: 1. DF payoff (cash or shares? Has mnkd been using the atm to raise the funds?) 2. Second UTHR molecule 3. Second UTHR milestone payment for 2019 4. Mexico/Canada filings 5. Told we would hear more about RLS this year. 6. ADA Posters7.Results of One Drop Study 8. Publication in major journal(s) as promised 9. Progress report on Peds study 10. Percent exercise of $1.60 warrants 11. Scripts hit 900 by year’s end The Bad: 1. Dilution (How much? And when?) 2. DF milestone payment Clearly the good outweighs the bad imho. It will be a slow grind up but at least mnkd seems headed in the right direction. The items listed are all significant, but I'm not so sure that so many of them are unambiguously good. For instance, results and progress reports needn't be good (they could be serious downers), and publications may not be in 'major' journals. Regarding the latter point, the publication experience to date suggests that forthcoming articles might appear in second (or third) tier places. (I'm not saying these things are more likely to be bad than good, just that a lot of them could be sort of a wash / neutral.) The rather poor (all things considered) ADA pediatric study poster may have just proven my point.
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Post by mnkdfann on Jun 5, 2019 18:27:31 GMT -5
IMO a cough is a more likely with pediatric than adult. Kids are just going to breathe in the way they want to breathe. They're also less used to suppressing a cough, or breathing irritating air in general True. But this was the 13-18 age group. I don’t see the younger being better. I have a hard time seeing patients losing interest because of the cough. I tried a cigaret when I was 8, and never tried anything like it again. But, Afrezza is like that... Many people will smoke cigarettes and put up with a cough because of the immediate nicotine pleasure. Not to mention, they are addictive. Maybe Afrezza powder should have nicotine added, or be caffeinated? (Just joking, though it might help with retention.)
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Post by mnkdfann on Jun 4, 2019 15:48:27 GMT -5
"Bioom" It is Biomm. Though Bioom sounds better and snappier.
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Post by mnkdfann on Jun 4, 2019 13:58:54 GMT -5
6.7 Million Followers from just one poster. As I remarked before, that poster is a Brazilian daily newspaper that tweets different often random items about 1,000 times a day (I mean that literally, it really does tweet that much).
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Post by mnkdfann on Jun 4, 2019 11:50:09 GMT -5
Love it!! Didn’t someone just said they didn’t advertise? I think all the posted stuff is in response to news, not advertising. If memory serves, only two countries in the world (the U.S. being one of them) allow direct-to-consumer advertising of prescription drugs. Doesn't mean you can't have a website or PR efforts, but it's not like here. The U.S. is a veritable paradise for pharmaceutical companies given the unregulated pricing and advertising opportunities. Indeed. In fact, the tweet from the account with "6.7M followers..." actually came from a Brazilian daily newspaper, that tweets random items about 1,000 times a day. While all publicity is good, I hope people don't go deluding themselves about advertising prospects.
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Post by mnkdfann on Jun 3, 2019 23:27:42 GMT -5
So mnkd finally received approval in Brazil. What is in store for the next six months as we reach the half way point in the year? (I am only including items that have a reasonable of occurring) The Good: 1. DF payoff (cash or shares? Has mnkd been using the atm to raise the funds?) 2. Second UTHR molecule 3. Second UTHR milestone payment for 2019 4. Mexico/Canada filings 5. Told we would hear more about RLS this year. 6. ADA Posters 7.Results of One Drop Study 8. Publication in major journal(s) as promised 9. Progress report on Peds study 10. Percent exercise of $1.60 warrants 11. Scripts hit 900 by year’s end The Bad: 1. Dilution (How much? And when?) 2. DF milestone payment Clearly the good outweighs the bad imho. It will be a slow grind up but at least mnkd seems headed in the right direction. The items listed are all significant, but I'm not so sure that so many of them are unambiguously good. For instance, results and progress reports needn't be good (they could be serious downers), and publications may not be in 'major' journals. Regarding the latter point, the publication experience to date suggests that forthcoming articles might appear in second (or third) tier places. (I'm not saying these things are more likely to be bad than good, just that a lot of them could be sort of a wash / neutral.) I guess it is a case of 'Hope for the best, plan for the worst'.
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Post by mnkdfann on Jun 3, 2019 23:22:34 GMT -5
Are advertisement rules for medications different in Brazil than the United States? Wheres the black box warnings? Wheres the FDA police to not allow advertising? Instagram, Facebook and other websites do not stop at a country border. Can Mannkind now put out a lot of advertising (in Portuguese) without worrying about being slapped on the wrist by the FDA? Maybe they need to produce some ads for the English speaking Brazilians. According to what I have seen and read, the U.S. is one of the nations that allows the freest advertising (direct to consumer) of pharmaceutical drugs. Pharmas are not allowed to advertise (direct to consumer) at all, in most nations. E.g., see: en.wikipedia.org/wiki/Direct-to-consumer_advertisingBrazil appears to be more restrictive than the U.S.: "In 2008 a new resolution from ANVISA (Control Agency for Sanitary Vigilance), Resolution 96 from December 17 was released, with focus on medication advertisements. It allows direct-to-consumer advertising of non-prescription medication, with restrictions on the type of drug and words and images that can be used, among other things. Advertisements for prescription medications can only appear in scientific, medical, or health professional journals." Afrezza being prescription, don't expect to see much in the way of advertising for it in Brazil.
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Post by mnkdfann on Jun 3, 2019 17:47:02 GMT -5
Translation of medicafitdiabetica's comment:
I made a summary of this news! Read it calmly, but the excitement is inevitable, right? (I.e. . Afrezza®, an ultra-rapid inhaled insulin for pre-meal use, was registered today by ANVISA. . Commercialized in the United States since its approval by the FDA in 2015, it will be available in Brazil until the fourth quarter of this year. . Supplied with a small, discreet, easy-to-use inhaler, it is given at the beginning of the meal. Afrezza®️ dissolves rapidly after inhalation into the lung and immediately reaches the bloodstream. Maximum insulin levels are achieved within 12 to 15 minutes after administration and decline by approximately 180 minutes. . In addition, Afrezza®️ has, among all the insulins available on the market, the action profile that most resembles physiological insulin, since the absorption pathway (lung) and form (insulin monomers) allow absorption and action of insulin more quickly than the others. . It is worth noting that Afrezza® should be used in combination with long acting insulin in patients with type 1 diabetes. Afrezza® is not recommended for the treatment of diabetic ketoacidosis and for patients who smoke. It has not yet been tested on people under 18 years of age. . The main limitation is the low range of dosages available. There are only three presentations: 4, 8 or 12 units, while injectable insulins are offered in doses of 1 unit, which allows more combination and personalization. . It is not yet possible to estimate how much the product will cost in Brazil. In the United States, the lowest dose, 4 units, costs $ 3.80, or about $ 15.
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Post by mnkdfann on Jun 2, 2019 20:51:28 GMT -5
keep looking the secretarial staff has left the board It is your claim to support, or not, not mine.
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Post by mnkdfann on Jun 2, 2019 20:31:19 GMT -5
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