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Post by bioexec25 on Jun 1, 2017 17:54:56 GMT -5
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Post by mytakeonit on Jun 1, 2017 18:20:56 GMT -5
Thanks bioexec25 ... so 2015 report says 10.4% of population age 20 - 79 is diabetic in Brazil. Kids don't count ... just like in the US studies. Also 4th leading cause of death in Brazil ... because you may be suffering from diabetes and terminal, but you die from a stroke. Then, you died because of stroke. Same as in the US studies. Only recently have they figured out that diabetes is 2nd only to cancer as reason for deaths. So, the 15M figure is probably low ... but, not having money to eat poor quality food and dancing like crazy ... yeah I can see the reason for a lower number than in the US. And for all you music lovers ... btw, I have this album ... www.youtube.com/watch?v=N6dbjMPhcEE
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Post by mountain74 on Jun 1, 2017 18:43:42 GMT -5
If I'm reading it right, they raised about 31 million reals (= about 10 million dollars) and the offering closed about 2 weeks ago.
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Post by brotherm1 on Jun 1, 2017 21:20:42 GMT -5
In other words, 10 million dollars could go over 3x as far in Brazil than it would in the US
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Post by brotherm1 on Jun 1, 2017 21:30:22 GMT -5
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Post by brotherm1 on Jun 1, 2017 21:34:27 GMT -5
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Post by brotherm1 on Jun 1, 2017 22:05:26 GMT -5
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Post by mountain74 on Jun 2, 2017 8:10:43 GMT -5
They appear to have had only 10 million American dollars in cash at the end of the first quarter. They have a strange website -- www.biomm.com -- which doesn't seem to say much of anything specific about what they do. Reading the annual report says they have been building some sort of large factory in Minas Gerais since 2014 for the production of various insulins, and that it's supposed to go into operation sometime next year. I think it also says that Brazil currently imports all of its insulin.
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Post by mnkdfann on Jun 2, 2017 8:34:29 GMT -5
Reading the annual report says they have been building some sort of large factory in Minas Gerais since 2014 for the production of various insulins, and that it's supposed to go into operation sometime next year. I think it also says that Brazil currently imports all of its insulin. I cannot read the language of the report, but what you are saying now seems odd. Unless Novo shuttered its insulin plants in Brazil. www.manufacturingchemist.com/news/article_page/Novo_Nordisk_inaugurates_Latin_Americas_largest_insulin_plant_in_Brazil/39300Could it be that the company was participating with Novo on its plant(s), by contributing technologies?
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Post by hellodolly on Jun 2, 2017 9:06:49 GMT -5
Where does it say that Afrezza has not been approved or is required to go through this? temperature and humidity testing with the FDA has not been done. Afrezza storage instructions. Not in Use: Refrigerated Storage 2-8ºC (36-46ºF)
In Use: Room Temperature Storage 25ºC (77ºF), excursions permitted 15-30ºC (59-86ºF) Sealed (Unopened) Blister Cards + Strips Must be used within 10 days www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf pg 20
Apidra storage instructions: www.accessdata.fda.gov/drugsatfda_docs/label/2008/021629s015lbl.pdf pg 43 • Store all unopened APIDRA in a refrigerator (not the freezer) between 36°F to 46°F (2°C to 8°C). Do not allow it to freeze. Do not use APIDRA if it has been frozen. • Keep APIDRA out of direct heat and light. • Do not use APIDRA if it has been overheated. • Do not use APIDRA if it is cloudy, colored, or if you see particles.
Opened APIDRA: Cartridge: • Store the opened cartridge system below 77°F (25°C) and away from direct heat and light. • Throw away the cartridge system 28 days after the first use even if it still contains APIDRA. • Do not store an opened cartridge system or OptiClik® insulin Pen in a refrigerator. • Do not use APIDRA if it is cloudy, colored, or if you see particles.
Sorry, but again...the first link by comny does not specify that Afrezza has not gotten approval, based on Brazil's requirements? That's all I'm asking...where is it represented in his link. It's only Brazils process...nothing in there about Afrezza, which seems that there was some misinformation
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Post by agedhippie on Jun 2, 2017 9:32:43 GMT -5
If I'm reading it right, they raised about 31 million reals (= about 10 million dollars) and the offering closed about 2 weeks ago. Odds are that is to fund their new factory. Originally it was meant to come on line this year but the shareholders made them fund it in stages. The factory will go live 2018 rather than 2017 because of the the staging of the build. In other words what you are looking at is a capital raise to pay for the next stage of the build, this is also why you have seen periodic raises in the past. The factory will produce Regular insulin. In the past that might have been an interesting link to Mannkind as an API but that door was shut with the renegotiated Amphastar agreement.
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Post by kc on Jun 2, 2017 11:19:48 GMT -5
When they are selling it wholesale to the Brazilian company we don't have to worry about anything more than supplying the Afrezza. Drugs sold in other countries are sometimes 90% cheaper than the USA. You want to get the Afrezza moving you need to sign a few deals like this one for supplying the product. Universal Health Care country then it might sell very cheap on the wholesale side but builds up production and that is good for MannKind long term.
Brazil has a problem. Poor country lots of diabetes cases to treat. Afrezza is the perfect product to help an entire nation with limited numbers of Doctors, Hospitals and treatment facilities help their patients. Again Telemed with Afrezza and titration will prove the story about early treatment with Afrezza will save lives and complications that cost a Gov Universal plan big treatment dollars from Diabetes complications.
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Post by agedhippie on Jun 2, 2017 12:01:45 GMT -5
When they are selling it wholesale to the Brazilian company we don't have to worry about anything more than supplying the Afrezza. Drugs sold in other countries are sometimes 90% cheaper than the USA. You want to get the Afrezza moving you need to sign a few deals like this one for supplying the product. Universal Health Care country then it might sell very cheap on the wholesale side but builds up production and that is good for MannKind long term.
Brazil has a problem. Poor country lots of diabetes cases to treat. Afrezza is the perfect product to help an entire nation with limited numbers of Doctors, Hospitals and treatment facilities help their patients. Again Telemed with Afrezza and titration will prove the story about early treatment with Afrezza will save lives and complications that cost a Gov Universal plan big treatment dollars from Diabetes complications. There is a reason that BIOMM is building a Regular insulin plant rather than an RAA plan and it's pricing. Brazil will use Regular insulin to treat it's diabetics in their health system as far as possible because the pricing for anything else will simply blow up their budget. The UK is looking at moving away from Lantus/Levemir/Tresiba for Type 2 diabetics and using NPH instead for the same cost control reasons. My feeling is that in Brazil the market for Afrezza is going to be the private sector where it will compete with the existing RAA insulins.
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Post by cedafuntennis on Jun 2, 2017 17:42:08 GMT -5
Hippie, I see it a bit differently. In Brasil as in the UK and many other countries with single payer HI, governments will want to reduce cost as you said. But you need to look at TCO (a parallel if you will). Treating diabetes cost is like an iceberg. You see the cost of Afrezza which is the tip of the iceberg, but most of the costs lie with treatments of problems caused by not having diabetes under control. Those costs are far greater that the cost of Afrezza which is not much more expensive than regular injectables anyway.
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Post by agedhippie on Jun 2, 2017 18:55:42 GMT -5
Hippie, I see it a bit differently. In Brasil as in the UK and many other countries with single payer HI, governments will want to reduce cost as you said. But you need to look at TCO (a parallel if you will). Treating diabetes cost is like an iceberg. You see the cost of Afrezza which is the tip of the iceberg, but most of the costs lie with treatments of problems caused by not having diabetes under control. Those costs are far greater that the cost of Afrezza which is not much more expensive than regular injectables anyway. Certainly the UK system takes that approach and NICE evaluates several parameters including quality of life. The problem is going to be that NICE is purely evidence based so they are going to take the trial data and base their decision off that. I think if the cost in use is equivalent to RAA then they will pass it. If the cost is higher than RAA then they will follow the same path as with Exubera and make it registered needle-phobics only. If Afrezza is EMA approved then people could buy it in the UK outside the NHS regardless of any NICE finding as NICE has no remit outside the NHS. It would obviously limit the market (insulin is free in the UK) but there will still be some people prepared to pay out of pocket.
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