Tinkerbell
Researcher
Watcher of the Skies
Posts: 143
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Post by Tinkerbell on Aug 9, 2017 15:40:38 GMT -5
I am afraid for exactly the reasons stated above that FDA and all of it's "supporting characters" will not be easily handing out requested label changes. BP interests are clearly not aligned with insurers. I hope I am wrong and FDA does the right thing. I hope I'm right and those at the FDA who are overseeing the label change request from MannKind are aware of the significant momentum around Afrezza and what it may look like on them if they don't award the correct label to it. The current label is wholly insufficient and does not describe Afrezza appropriately. So what's been happening of late which the FDA might be aware of (though it should not influence their decision): 1) Meetings to discuss the JDRF and Afrezza pediatric protocol design; 2) Recent testimony in Congress of Afrezza's impact (Jeff Sparks) and importance of keeping diabetes research alive; 3) The white paper from VDEX - a business entity hell bent on taking patients away from Endos/Primary Care Physicians who ignore Afrezza. 4) Charles Mattocks - a TV chef intends to outshine the AMA/AACE with respect to diabetes care and what it takes to treat them. Frankly, Afrezza would be easier and way cheaper. 5) Dash Diabetes Network - Dr. Dash prescribing VDEX to people who don't want to even put up with the shenanigans of MDs bought by Big Pharma. 6) Afrezza and One Drop partnership - Amazon drop ships. Try to stop that with Trump in office. If those responsible for overseeing the label change don't see what's happening around them IN ADDITION TO the fact that Afrezza's unique PK/PD profile is the only one of it's kind for diabetics? All I can say is if Trump gets wind of the FDA squashing such for an innovative American company like MannKind and FOR NO GOOD REASON? Well I would not want to be the FDA Commissioner that day. That's all.....
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Post by buyitonsale on Aug 9, 2017 16:01:12 GMT -5
Thinking that FDA is not aware of anything is naive.
Thinking that FDA is not influenced by what it's aware of is naive.
Thinking that FDA is always going to do the right thing and not be influenced by anything or anybody is naive.
Bureaucracy is alive and well.
Lobbying is alive and well
I often think about Martin Shkreli and his infamous letters to FDA... Who made the decision to put up roadblocks for Afrezza? The person sending the letters or FDA or someone else? In my mind Shkreli is just a scape goat...
Management is putting a lot of emphasis on this label change and rightfully so. I sure hope that they use all connections and resources to make that label change happen.
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Post by letitride on Aug 9, 2017 19:39:23 GMT -5
The insurance is the greatest holds, because people don't want to pay for their health from their pocket. But at the same time they are more then ready to pay for their pleasure - 500,000 preorders for new budget Tesla, (36k-45k) which to wait months if not years. I was presenting afrezza to a GP the other day and she was really impressed and she concluded with and insurance is the problem. And I said not really when you consider I'm not a wealthy guy and I had a 300 dollar a week nut to cover for a bar tab for years to destroy my health how much more should I be willing to pay to save it. And I got to tell you that may also be the problem I don't want to know what it cost to fix my health I just want to continue to have fun with whats left of my health.
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Post by straightly on Aug 9, 2017 21:15:03 GMT -5
The insurance is the greatest holds, because people don't want to pay for their health from their pocket. But at the same time they are more then ready to pay for their pleasure - 500,000 preorders for new budget Tesla, (36k-45k) which to wait months if not years. I do not want to pay for my health from my pocket, that's why I buy insurance instead. What's wrong with budget Tesla? I reserved one and am patiently waiting. If it turned out to be anything like the model S at all, it will be a pleasure. I did not do it for pleasure, though. I am sure you know what I mean.
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Post by straightly on Aug 9, 2017 21:18:28 GMT -5
The insurance is the greatest holds, because people don't want to pay for their health from their pocket. But at the same time they are more then ready to pay for their pleasure - 500,000 preorders for new budget Tesla, (36k-45k) which to wait months if not years. I do not want to pay for my health from my pocket, that's why I buy insurance instead. What's wrong with budget Tesla? I reserved one and am patiently waiting. If it turned out to be anything like the model S at all, it will be a pleasure. I did not do it for pleasure, though. I am sure you know what I mean. Oh, forgot to mention, I could have bought my model S, when my waiting was up, if it were not for this stock. Sad me.
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Post by sportsrancho on Aug 10, 2017 6:11:16 GMT -5
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Post by peppy on Aug 10, 2017 7:59:48 GMT -5
The physicians sure threw out every other medication. how about this one? and this one?
The physicians did present a smorgasbord of alternatives. Why do you insist on heaven? We have many options in hell.
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Post by dreamboatcruise on Aug 10, 2017 10:59:26 GMT -5
Thank SNY for that. Wasted time in not even being able to apply in EU. Would seem hard to generate political pressure through the media in UK given that health service there can simply say "the manufacturer hasn't yet applied for approval." Though I wish him the best and encourage him to try.
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Post by MnkdWASmyRtrmntPlan on Aug 10, 2017 11:18:38 GMT -5
I do not want to pay for my health from my pocket, that's why I buy insurance instead. What's wrong with budget Tesla? I reserved one and am patiently waiting. If it turned out to be anything like the model S at all, it will be a pleasure. I did not do it for pleasure, though. I am sure you know what I mean. Oh, forgot to mention, I could have bought my model S, when my waiting was up, if it were not for this stock. Sad me. I know what you mean, straightly. I will be needing a new car fairly soon and I would love a model 3, but I will now have to stretch money from somewhere for that ... but ... I could have bought 3 of them with cash if it weren't for MNKD.
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Post by sportsrancho on Aug 13, 2017 19:15:49 GMT -5
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Post by sportsrancho on Aug 14, 2017 13:34:32 GMT -5
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Post by sportsrancho on Aug 14, 2017 13:39:11 GMT -5
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Post by sportsrancho on Aug 14, 2017 13:43:11 GMT -5
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Post by sportsrancho on Aug 16, 2017 17:25:58 GMT -5
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Post by hillsave on Aug 16, 2017 17:31:17 GMT -5
Love the "Pancreas in your Pocket" slogan
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