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Post by veritasfiliatemporis on Dec 29, 2018 17:03:33 GMT -5
Europe is pay to play. Big Money has to be paid to Europe to be approved. When approved, it will not be covered by European health insurance. Sanofi and NovoNordisk both based in Europe. Europe is a bit protectionist. No Target Stores or Walmarts in Europe and a can of coca-cola will cost the same as a bottle of wine. I am European. Why should Afrezza not be covered in Europe ? There is no reason why it shouldn't. A can of Coke doesn't cost the same as wine. Please explain what You are trying to tell us here..... Yep... Good wine is normally expensive, good coke normally cheap, he got cheap wine or he paid too much for a coke.
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Post by peppy on Dec 30, 2018 2:04:32 GMT -5
Europe is pay to play. Big Money has to be paid to Europe to be approved. When approved, it will not be covered by European health insurance. Sanofi and NovoNordisk both based in Europe. Europe is a bit protectionist. No Target Stores or Walmarts in Europe and a can of coca-cola will cost the same as a bottle of wine. I am European. Why should Afrezza not be covered in Europe ? There is no reason why it shouldn't. A can of Coke doesn't cost the same as wine. Please explain what You are trying to tell us here..... quote: Why should Afrezza not be covered in Europe ? There is no reason why it shouldn't. agedhippie reply: oh goody. good to know. coca-cola, I paid 5 US dollars for a can of cocacola in Rome in the 1990's. A bottle of wine cost that in Rome, at the time.
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Post by agedhippie on Dec 30, 2018 8:37:30 GMT -5
I am European. Why should Afrezza not be covered in Europe ? There is no reason why it shouldn't. A can of Coke doesn't cost the same as wine. Please explain what You are trying to tell us here..... quote: Why should Afrezza not be covered in Europe ? There is no reason why it shouldn't. agedhippie reply: oh goody. good to know. coca-cola, I paid 5 US dollars for a can of cocacola in Rome in the 1990's. A bottle of wine cost that in Rome, at the time. Afrezza is not covered in Europe because it is not approved. EU insulin prices are around 10% of US insulin prices so Afrezza would need to be priced the same as Humalog on a cost to treat basis (if you need more Afrezza than RAA then the cost of Afrezza would be correspondingly lowered). The NHS pays £29.46 (about $38.25) for a pack of five pens, or £16.61 for a 1000u vial, in the US those prices are an order of magnitude higher. At this time the ROI is not there for Mannkind to put in the time, effort, and money needed.
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Post by #NoMoreNeedles on Jan 3, 2019 11:22:15 GMT -5
Then why did Mike shade in the map for Europe?
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Post by mytakeonit on Jan 3, 2019 13:41:43 GMT -5
I think Baba did that with his crayons.
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Post by agedhippie on Jan 3, 2019 13:51:42 GMT -5
Then why did Mike shade in the map for Europe? Because it looked good? Because they will sell Afrezza in Europe at some point. Before that happens though they have to get better traction in the US which is ten times (literally) as profitable.
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Post by jmkopp on May 17, 2019 8:29:09 GMT -5
I wouldn’t worry about it (at this point) we have bigger problems... Lets see if we can get approved in Brazil, and see what Afrezza’s sales look like there first. Why not those other countries? We’re a bit strapped for cash... (Quote from old article on Brazil) Oct. 23, 2017 MannKind (NASDAQ:MNKD) and Biomm SA (B3:BIOM3) announced today that Afrezza has been submitted to ANVISA in Brazil for approval. Earlier this year, MannKind had stated that it anticipated filing in Brazil in Q4, and that it anticipated a decision from the South American nation by Q4 2018. Brazil is the 5th most populated country in the word and in the top 10 when it comes to people with diabetes. In the early summer of this year, MannKind announced that it had entered into an agreement with BIOMM SA. The deal brought no up-front cash, and terms of the relationship have never been disclosed. The absence of a "material event" filing has left many investors wondering what the possible terms could be. The news release today offered no additional information. What we know is that Biomm SA was responsible for submitting the drug to the regulatory body for distributing, promoting, and selling. MannKind would be responsible for the manufacture and supply of Afrezza. Brazil, with universal healthcare, has strict cost controls on the drugs that it approves. Pricing is controlled by CMED. Perhaps one reason that there is not much transparency regarding the terms of the deal is that, as yet, the pricing structure is unknown. I know this sounds a little crazy conspiracy(ish), but this stock over the last 7-8 years has made me a little sensitive. Is anyone concerned that the money raise was secondary to some potentially bad news out of Brazil; like a delay in the approval? I am a little nervous about big pharma money being funneled to some of the decision makers to persuade a delay the approval. It seems to happen in other areas like bidding for World Cups and Olympics. Would that be unheard of in a drug approval? I would hope that wouldn't be the case, but again, it seems like there have been so many potentially nefarious people/incidents involved in stopping the success of Afrezza. Check out this link on the corruption in Brazil finance.yahoo.com/news/exclusive-fbi-targets-johnson-johnson-100519603.html
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Post by matt on May 17, 2019 9:58:00 GMT -5
Europe is a bit more complicated than this. The approval process via the Europeans Medicines Agency is similar to the FDA and approval under that mechanism lets a company sell anywhere in the EU countries plus Lichtenstein, Iceland, Norway, and Switzerland who are EFTA but not EU members. It is also possible to get approval country by country but that procedure is rarely used anymore.
Regulatory approval is one thing; reimbursement is another. Approval is centralized, payment is decentralized. Wealthy countries, like Germany and Norway, cover more medicines at higher prices than countries with less money, like Portugal and Greece. Pharmas used to price drugs at different price points, higher in Germany and lower in Portugal for example, but this created a gray market where German pharmacies would buy from Portuguese wholesalers to get lower prices, and the EU courts ruled that this was a legal way to do business. Most companies have gone to a model where they will only supply their drugs at a single EU price which means that in many countries drug have regulatory approval but patients have essentially no access to the drug. There are 29 separate markets to deal with and 29 different sets of rules; there is no "European" market. In some places the reimbursement depends on the provincial government so it gets even more complicated within a country as there is not a single payor is these places. Madrid, for example, pays its bills in about 180 days and they are the fastest local government in Spain, in other regions payment does not happen for over 500 days. In short, it gets messy.
Since Afrezza is inherently more expensive than every other insulin product, there may be a limited market in Germany, Austria, Switzerland, Netherlands, perhaps Belgium, and some of the Nordic countries. However, UK, France, Spain, Italy, southern / Mediterranean Europe, and newer members that used to be part of the East Bloc do not have sufficiently generous healthcare systems. As always, there are pockets of wealthy private pay patients that don't care about the cost but it is hard to build a market on the backs of those individuals.
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