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Post by otherottawaguy on Feb 26, 2018 13:50:21 GMT -5
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Post by otherottawaguy on Feb 26, 2018 13:58:06 GMT -5
2018-02-26 UK: showing nothing of interest. EU:showing nothing of interest. Can: Query the site for "Afrezza" get the following: About 2 search results for "afrezza\" What's New - Drug Products - Canada.ca www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html2 days ago ... Latest Health Canada content on drug products including weekly drug Notice of Compliance (NOC) updates, Summary Basis of Decisions (SBD), fact sheets and newsletters. MARC21 publications.gc.ca/site/eng/9.616099/marcXml.html?MODS=1590, |a02-39|b2002-09-27. 690, 07|aAnalysis|2gcpds. 690, 07|aFish|2gcpds. 690 , 07|aHabitats|2gcpds. 690, 07|aLakes|2gcpds. 690, 07|aModelling|2gcpds. 720, 1 |aFrezza, T. 720, 1 |aMinns, Charles K. 830, #0|aCanadian technical report of fisheries and aquatic sciences, |x0706-6457|v2600|w(CaOODSP)9.514691. The bottom on is referencing someone by the name of A. Frezza, so its a dead end. But the first reference returned remains of interest, just can't find where afrezza is mentioned or why the post was returned. The first reference has been returned for some months now, so don't think that something new has been added recently. OOG
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Post by lakers on Feb 26, 2018 15:30:54 GMT -5
Mnkd will file by itself in Canada this year. Hope the approval won’t take too long (<9 mos) for Ottawa. By EOY, hopefully A will have been available in Brazil, Canada. What’s the latest PWD population in these countries?
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Post by mnkdfann on Feb 26, 2018 16:04:06 GMT -5
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Post by casualinvestor on Feb 27, 2018 9:22:33 GMT -5
The thing is, if nationalized health care can be convinced that Afrezza significantly reduces the overall cost of diabetic care, they should be the first ones to want to use it. Much the same as the VA and medicare, they are paying for the health care of the individual for the rest of that persons life. Amputations, eye problems, neuropathy and all.
I don't think that proving that Afrezza significantly reduces the average cost of Diabetic care for individuals has been done, and I'm not sure it can be done without some very large studies. Heck, I'm not even sure that it's true for the average diabetic unless they get good coaching.
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Post by boca1girl on Feb 27, 2018 9:51:12 GMT -5
The thing is, if nationalized health care can be convinced that Afrezza significantly reduces the overall cost of diabetic care, they should be the first ones to want to use it. Much the same as the VA and medicare, they are paying for the health care of the individual for the rest of that persons life. Amputations, eye problems, neuropathy and all. I don't think that proving that Afrezza significantly reduces the average cost of Diabetic care for individuals has been done, and I'm not sure it can be done without some very large studies. Heck, I'm not even sure that it's true for the average diabetic unless they get good coaching. Agree with most of your post but I believe real life results of current users could influence decisions “without some very large studies”.
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Post by otherottawaguy on Feb 27, 2018 13:38:08 GMT -5
Politicians here are starting to talk about a "National" prescription plan in this years budget. Seems that we are one of a few countries that have health care but no prescription care plans.
We have a population of 36 million, which means that we probably have close to 3.6M diabetics (360K Type 1 and 3.2M Type 2).
Danbury could just point one (maybe 2) of their production lines at Canada with bilingual labeling and bang, MNKD is running at break even...but first they have got to get it by Health Canada.
I had a friend look at the product, its literature in the demo box (monogragh???), opinion was that it looked like they had every required to make a submission.
This person used to work at Health in the drug approvals division, albeit not in diabetes area. They also offered to call contacts at Health Canada to see if anything was in the works, but alas did not have any luck on that front.
OOG
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Post by mnkdfann on Feb 27, 2018 13:41:25 GMT -5
Politicians here are starting to talk about a "National" prescription plan in this years budget. Seems that we are one of a few countries that have health care but no prescription care plans. www.cbc.ca/news/health/hoskins-pharmacare-1.4552739CBC News has learned former Ontario health minister Eric Hoskins will chair a federal government advisory council with a goal of creating a national pharmacare plan. Hoskins announced his resignation as minister this afternoon without providing any details. A federal government source has told CBC News the council's mandate will be to "consult a wide range of stakeholders, provinces, territories, Indigenous groups and experts" and then provide the government with options on how to proceed with a national pharmacare program. The advisory council has until 2019 to complete its job. It's expected the federal government will make the announcement during Tuesday's budget.
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Post by mnkdfann on Feb 27, 2018 13:46:49 GMT -5
The thing is, if nationalized health care can be convinced that Afrezza significantly reduces the overall cost of diabetic care, they should be the first ones to want to use it. I agree in theory, but I think the real world practice is different. I think shorter term budgetary constraints will trump long term savings of the sort you describe. One article I linked to earlier talks about how life saving drugs in New Zealand cost 10 times less than in Canada. I think that is the sort of savings the Canadian system is targetting. Savings through better negotiation, and hard bargaining. IMO, that actually bodes a little ill for Afrezza's chances in Canada.
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Post by mnkdfann on Feb 27, 2018 23:01:22 GMT -5
MARC21 publications.gc.ca/site/eng/9.616099/marcXml.html?MODS=1590, |a02-39|b2002-09-27. 690, 07|aAnalysis|2gcpds. 690, 07|aFish|2gcpds. 690 , 07|aHabitats|2gcpds. 690, 07|aLakes|2gcpds. 690, 07|aModelling|2gcpds. 720, 1 |aFrezza, T. 720, 1 |aMinns, Charles K. 830, #0|aCanadian technical report of fisheries and aquatic sciences, |x0706-6457|v2600|w(CaOODSP)9.514691. The bottom on is referencing someone by the name of A. Frezza, so its a dead end. But the first reference returned remains of interest, just can't find where afrezza is mentioned or why the post was returned. The first reference has been returned for some months now, so don't think that something new has been added recently. OOG No biggie, but the name is actually T. Frezza (with co-author Charles K. Minns): publications.gc.ca/site/eng/236393/publication.htmlThe lower cases "a" in aFrezza appears to be some delimiter.
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Post by lakers on Mar 2, 2018 1:05:38 GMT -5
Approximately 11 million Canadians live with diabetes or prediabetes and that number may to increase to more than 13 million by 2026. Fiasp was approved by Health Canada on January 6, 2017 for the treatment of adult patients with diabetes mellitus who require mealtime insulin for the control of hyperglycemia. asweetlife.org/fiasp-new-fast-acting-insulin-now-available-in-canada/March 27, 2017 By ASweetLife Team Novo Nordisk Canada Inc. announced that Fiasp (insulin aspart), a faster acting mealtime insulin, is now approved and available in Canada. This shows Afrezza can be fast tracked in Canada.
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Post by silentknight on Mar 2, 2018 7:03:44 GMT -5
Approval in Canada, heck approval anywhere else, would be beneficial but I'm skeptical that MNKD can succeed in convincing Health Canada or any other socialized medicine system of the benefits of Afrezza. MNKD, despite all its efforts, has done a pretty poor job of convincing U.S. doctors and diabetics of the benefits of Afrezza, as evidenced by the poor script numbers. Given that, I find it hard to believe that they could do it any better in Canada.
Perhaps they'd have better success under a system of nationalized medicine as opposed to the U.S. healthcare system, but in terms of carrying the message far and wide that Afrezza is better than other insulin, their actions to date have been extremely underwhelming. Perhaps Dr. Kendall can help with that, but they haven't done a very good job of getting the word out over the last few years.
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Post by compound26 on Mar 5, 2018 14:45:26 GMT -5
India and China: here comes Afrezza! Based on what Mike stated in the last CC, it appears the two countries that he referred to have term sheets (one signed and the other is being finalized) are India and China. Evidence 1: investors.mannkindcorp.com/static-files/76875d41-2743-4a29-a76a-bc00f6d1ea33On the slide of international expansion (Slide No. 30), India and China are the only countries have additional notation. You would think there are some reasons why Mannkind did that. Evidence 2: Mike said on the call "I believe with the 80 million to 100 million people in some of these markets, who have and AIC at 10 [ph] just a minor share in these segments will offset a tremendous difference in people's lives." That is referring to India. On the slide for international expansion, the notation for India is : 80 million people in India with diabetes; average A1C is 10. Evidence 3: Someone in stocktwits mentioned that Mannkind IR is saying they are negotiating for a China licensing deal. stocktwits.com/pmhaps/message/113712041Evidence 4: In the interview that Mike did last October (interview with SiriusXM Business Radio Powered by The Wharton School), Mike talking about filing in the next 12 month in regions that will cover 50% of the world population. To achieve that, Mannkind got to expand to both China and India this year. seekingalpha.com/article/4151494-mannkinds-mnkd-ceo-michael-castagna-q4-2017-results-earnings-call-transcript?part=singleAdditionally, we have a [signed] term sheet for a large market outside the U.S. and we're in the process of finalizing a second term sheet. One of both is we hope to announce in the first of this year, but as you know, these things take time. We do expect these deal structures will have a combination of upfront milestones royalties and more importantly we need to continue to serve patients around the world - while we know these markets may not generate a lot of cash, they will tremendously make a difference for society, and I believe with the 80 million to 100 million people in some of these markets, who have and AIC at 10 [ph] just a minor share in these segments will offset a tremendous difference in people's lives. In the end, we have a large manufacturing plant that we continue to maintain and these markets will continue queue up some of the purchase commitment in the earlier while we delivered sustained growth for the company here in the U.S. and other markets. Note: seeking alpha had it as a [fine] term sheet. But one listened to the CC, Mike clearly said [signed] term sheet.
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Post by pat on Mar 5, 2018 14:53:39 GMT -5
Complete speculation on my part but Mike made reference to high fixed cost (manufacturing line sunk cost) and very low subsequent marginal cost for production. If we can sell product to either country at something at or above cost - should improve overall profitability quite a bit as we ramp sales in the US.
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Post by compound26 on Mar 5, 2018 15:02:55 GMT -5
pat agree with your analysis. Mannkind will probably sell at or just above fixed cost to these countries. By the way, Mike also confirmed that the big insurance from whom they won a contract is CVS, which confirmed my speculation back in January. mnkd.proboards.com/post/137394 (Is the big PBM Mike referred to in the presentation CVS?)
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