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Post by ltta on Jan 6, 2019 20:41:08 GMT -5
Thank you sayhey! When asking about HMOs, I was thinking Kaiser Permanente and other key payers. If Mankind could get them onboard would the dominoes likely start to fall? Mike C said in the last call: “The third topic here I want address is payers/patient access. We are continuing to see positive payer coverage as we start out 2019 as evidenced by our recent signing of the contract with Kaiser [ph] and ongoing discussions with other key payers.” [remainder clipped] Then it sure would have been nice for MannKind's Marketing and IR departments to have put out a PR to that effect. "MannKind Announces Agreement with Kaiser for Coverage of Afrezza Inhaled Insulin."
Yes... and how about a PR about this:
"Our STAT study helping change the recent ADA standards of care..."
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Post by sportsrancho on Jan 6, 2019 20:43:10 GMT -5
Is anybody home? To the Board of Directors, create some shareholder value!
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Post by mnholdem on Jan 6, 2019 20:54:58 GMT -5
It's the CEO's responsibility to manage the company, communicate his expectations and to hold accountable its officers and managers. A Board of Directors hold the CEO accountable for how s/he manages the company and they may use Key Performance Indicators to measure company performance but, IMO, it's not the role of the BoD to personally manage the company's employees themselves.
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Post by stevil on Jan 6, 2019 23:33:51 GMT -5
I have to disagree with the posts in opposition to bringing HbA1c down quickly. Let me admit that I'm not a doctor, but as the Founder of Vdex along with my very close physician friend, I get medical input on all aspects of Vdex, all the time. I have 3-4 different physicians that I can access quickly. All are in favor of attacking HbA1c levels aggressively. It is true when you bring someone from an A1c of 14 to 7 there is an adjustment period for their body, but that is brief. There can be some "symptoms" of hypoglycemia, but theses are transitory and not dangerous. It's just the body adapting to the new normal. However, the salutary benefits of a more rapid drop in HbA1c are huge. Some, such as much better sleep, really help reinforce the change and keep the patient motivated to improve. I think that in part explains the high compliance among Vdex patients. A subtle point is the issue of Afrezza's mode of action in reducing HbA1c. Because Afrezza attacks the post prandial excursions, or more accurately stated, preempts them, Vdex gets more bang for the buck with less danger. Here's why: the post prandial excursions where blood sugar levels skyrocket into the 300-400s and more for many patients, are what really drive up the HbA1c values. Since HbA1c is an average of lots of data points, if one eliminates the worst data one gets a bigger effect on the average than if one brought all data points down a small amount. In statistical terms, we're eliminating outlier data. Even if we don't address the basal data we still see a large effect on A1c. But, here's a key point: since we don't initially address the basal data, we haven't so dramatically changed the existing blood sugar state of the patient. I apologize for not making this clearer, but what I'm trying to explain is that there is a statistical effect that is not necessarily indicative of a physiologic effect. I've never seen this issue addressed in the literature but that may be because never had a product before that could do it. Just one more way Afrezza is ground-breaking How closely do you guys monitor electrolytes? I don’t understand how that aggressive of therapy wouldn’t throw them off...
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Post by vdexdiabetes on Jan 7, 2019 1:12:57 GMT -5
Stevil, we've had zero problems. I know that seems hard to believe, but I wouldn't misrepresent this situation. Rapid HbA1c reduction such as we've seen at Vdex really hasn't been seen before. Of course, there's never been a product like Afrezza before. I can't say that we, or anyone else outside of MNKD, fully understands the implications of the use of Afrezza. It's just so different. I've said many times, "Afrezza's at least as good as Al Mann said it was." Further, we discovered some things in our use of Afrezza that were unknown even to MNKD management.
What I'll say in overview, and these sentiments are shared by our Medical Advisory Team, is that the best way to manage blood sugar is the way the body does naturally. As all on this board know, that's what Afrezza does. IMO there's simply no argument for the existing ADA protocol once one understands Afrezza. We've had too many patients come in loaded up on orals, maybe along with GLPs and/or insulin, feeling terrible and apathetic about their condition. Some literally talk about just getting off everything and accepting their fate, which they know means death. You put those patients on aggressive doses of Afrezza and in short order change their lives. This is not hyperbole or salesmanship. You literally change their lives by giving them back control of their condition. Predictably, a whole host of physical and psychological benefits flow from this. This is not because Vdex is so wonderful but because Afrezza is.
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Post by Deleted on Jan 7, 2019 4:32:57 GMT -5
Stevil, we've had zero problems. I know that seems hard to believe, but I wouldn't misrepresent this situation. Rapid HbA1c reduction such as we've seen at Vdex really hasn't been seen before. Of course, there's never been a product like Afrezza before. I can't say that we, or anyone else outside of MNKD, fully understands the implications of the use of Afrezza. It's just so different. I've said many times, "Afrezza's at least as good as Al Mann said it was." Further, we discovered some things in our use of Afrezza that were unknown even to MNKD management. What I'll say in overview, and these sentiments are shared by our Medical Advisory Team, is that the best way to manage blood sugar is the way the body does naturally. As all on this board know, that's what Afrezza does. IMO there's simply no argument for the existing ADA protocol once one understands Afrezza. We've had too many patients come in loaded up on orals, maybe along with GLPs and/or insulin, feeling terrible and apathetic about their condition. Some literally talk about just getting off everything and accepting their fate, which they know means death. You put those patients on aggressive doses of Afrezza and in short order change their lives. This is not hyperbole or salesmanship. You literally change their lives by giving them back control of their condition. Predictably, a whole host of physical and psychological benefits flow from this. This is not because Vdex is so wonderful but because Afrezza is. Could not find your previous comment, but wanted ask what is "going nuclear"?
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Post by akemp3000 on Jan 7, 2019 5:39:37 GMT -5
Stevil, we've had zero problems. I know that seems hard to believe, but I wouldn't misrepresent this situation. Rapid HbA1c reduction such as we've seen at Vdex really hasn't been seen before. Of course, there's never been a product like Afrezza before. I can't say that we, or anyone else outside of MNKD, fully understands the implications of the use of Afrezza. It's just so different. I've said many times, "Afrezza's at least as good as Al Mann said it was." Further, we discovered some things in our use of Afrezza that were unknown even to MNKD management. What I'll say in overview, and these sentiments are shared by our Medical Advisory Team, is that the best way to manage blood sugar is the way the body does naturally. As all on this board know, that's what Afrezza does. IMO there's simply no argument for the existing ADA protocol once one understands Afrezza. We've had too many patients come in loaded up on orals, maybe along with GLPs and/or insulin, feeling terrible and apathetic about their condition. Some literally talk about just getting off everything and accepting their fate, which they know means death. You put those patients on aggressive doses of Afrezza and in short order change their lives. This is not hyperbole or salesmanship. You literally change their lives by giving them back control of their condition. Predictably, a whole host of physical and psychological benefits flow from this. This is not because Vdex is so wonderful but because Afrezza is. I would love to see the smile on Al Mann's face if he could be here to read this post. The genius of a man did many spectacular things in his life but Afrezza remained his favored child at the time of his passing. He knew it's global potential. It's wonderful that many in the world are finally slowly but gradually waking up to this as well. Great work VDex!
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Post by peppy on Jan 7, 2019 6:09:22 GMT -5
Stevil, we've had zero problems. I know that seems hard to believe, but I wouldn't misrepresent this situation. Rapid HbA1c reduction such as we've seen at Vdex really hasn't been seen before. Of course, there's never been a product like Afrezza before. I can't say that we, or anyone else outside of MNKD, fully understands the implications of the use of Afrezza. It's just so different. I've said many times, "Afrezza's at least as good as Al Mann said it was." Further, we discovered some things in our use of Afrezza that were unknown even to MNKD management. What I'll say in overview, and these sentiments are shared by our Medical Advisory Team, is that the best way to manage blood sugar is the way the body does naturally. As all on this board know, that's what Afrezza does. IMO there's simply no argument for the existing ADA protocol once one understands Afrezza. We've had too many patients come in loaded up on orals, maybe along with GLPs and/or insulin, feeling terrible and apathetic about their condition. Some literally talk about just getting off everything and accepting their fate, which they know means death. You put those patients on aggressive doses of Afrezza and in short order change their lives. This is not hyperbole or salesmanship. You literally change their lives by giving them back control of their condition. Predictably, a whole host of physical and psychological benefits flow from this. This is not because Vdex is so wonderful but because Afrezza is. Quote: We've had too many patients come in loaded up on orals, maybe along with GLPs and/or insulin, feeling terrible and apathetic about their condition. Some literally talk about just getting off everything and accepting their fate, which they know means death. You put those patients on aggressive doses of Afrezza and in short order change their lives.
Reply: Metformin, plus, SGLT2's just those two. The metformin stopping my liver from making glucose. the sglt2 sending glucose out my bladder by first increasing the threshold then preventing reabsorption of the glucose; so affecting the kidneys. Throw in some GLP's - Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.Back to your words, "feeling terrible and apathetic"The liver, the kidneys, the Krebs cycle of every cell in the body. All in the standards of care. What changed with the standards care this year to my eyeballs, is warnings to be less aggressive with HbA1c, secondary to hypoglycemia. you take metformin, A SGLT-2 www.screencast.com/t/hNmWaLLjN5FLA GLP You end up feeling like Chit.
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Post by mango on Jan 7, 2019 7:55:02 GMT -5
Stevil, we've had zero problems. I know that seems hard to believe, but I wouldn't misrepresent this situation. Rapid HbA1c reduction such as we've seen at Vdex really hasn't been seen before. Of course, there's never been a product like Afrezza before. I can't say that we, or anyone else outside of MNKD, fully understands the implications of the use of Afrezza. It's just so different. I've said many times, "Afrezza's at least as good as Al Mann said it was." Further, we discovered some things in our use of Afrezza that were unknown even to MNKD management. What I'll say in overview, and these sentiments are shared by our Medical Advisory Team, is that the best way to manage blood sugar is the way the body does naturally. As all on this board know, that's what Afrezza does. IMO there's simply no argument for the existing ADA protocol once one understands Afrezza. We've had too many patients come in loaded up on orals, maybe along with GLPs and/or insulin, feeling terrible and apathetic about their condition. Some literally talk about just getting off everything and accepting their fate, which they know means death. You put those patients on aggressive doses of Afrezza and in short order change their lives. This is not hyperbole or salesmanship. You literally change their lives by giving them back control of their condition. Predictably, a whole host of physical and psychological benefits flow from this. This is not because Vdex is so wonderful but because Afrezza is. Quote: We've had too many patients come in loaded up on orals, maybe along with GLPs and/or insulin, feeling terrible and apathetic about their condition. Some literally talk about just getting off everything and accepting their fate, which they know means death. You put those patients on aggressive doses of Afrezza and in short order change their lives.
Reply: Metformin, plus, SGLT2's just those two. The metformin stopping my liver from making glucose. the sglt2 sending glucose out my bladder by first increasing the threshold then preventing reabsorption of the glucose; so affecting the kidneys. Throw in some GLP's - Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.Back to your words, "feeling terrible and apathetic"The liver, the kidneys, the Krebs cycle of every cell in the body. All in the standards of care. What changed with the standards care this year to my eyeballs, is warnings to be less aggressive with HbA1c, secondary to hypoglycemia. you take metformin, A SGLT-2 www.screencast.com/t/hNmWaLLjN5FLA GLP You end up feeling like Chit. Those do nothing to restore the deficient Ca2+ signaling that is causing diminished insulin secretion and worsening first & second phase release. Bunk Ca2+ signalling will cause beta cell failure. Metformin is an energy disruptor. How does it help restore Ca2+ homeostasis in beta cells?
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Post by mnholdem on Jan 7, 2019 9:25:01 GMT -5
Stevil, As a follow up to VDex’s response to your question, you may want to send a PM to spiro (one of the PB moderators). Within a year of beginning his Afrezza therapy (not with VDex) his personal Doctor was able to take him off his alphabet soup of medications for liver problems that were likely the result of metformin and other diabetes meds he had been taking for years. He might fill you in. Best wishes!
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Post by travis1953 on Jan 7, 2019 9:36:08 GMT -5
Stevil, we've had zero problems. I know that seems hard to believe, but I wouldn't misrepresent this situation. Rapid HbA1c reduction such as we've seen at Vdex really hasn't been seen before. Of course, there's never been a product like Afrezza before. I can't say that we, or anyone else outside of MNKD, fully understands the implications of the use of Afrezza. It's just so different. I've said many times, "Afrezza's at least as good as Al Mann said it was." Further, we discovered some things in our use of Afrezza that were unknown even to MNKD management. What I'll say in overview, and these sentiments are shared by our Medical Advisory Team, is that the best way to manage blood sugar is the way the body does naturally. As all on this board know, that's what Afrezza does. IMO there's simply no argument for the existing ADA protocol once one understands Afrezza. We've had too many patients come in loaded up on orals, maybe along with GLPs and/or insulin, feeling terrible and apathetic about their condition. Some literally talk about just getting off everything and accepting their fate, which they know means death. You put those patients on aggressive doses of Afrezza and in short order change their lives. This is not hyperbole or salesmanship. You literally change their lives by giving them back control of their condition. Predictably, a whole host of physical and psychological benefits flow from this. This is not because Vdex is so wonderful but because Afrezza is. Why not go ahead and do a study describing your methodology and write it up for a diabetes journal?
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Post by uvula on Jan 7, 2019 10:02:11 GMT -5
Mr. VDEX, would you be able to adress these questions:
Are your patients type 1 or 2 or both?
For type 2, how can mnkd get insurance companies to cover afrezza when it is so much more expensive than melformin? Do we first have to convince doctors to put pressure on the insurance companies?
Thank you
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Post by stocker on Jan 7, 2019 20:24:18 GMT -5
sayhey, I highly regard your input…. What do you think about HMOs and Afrezza? Less Endos, less cost - less hypos, less cost - less diabetic complications, less cost - etc. If Afrezza can save them money, will they ever see the light? and how? I tried working with a large company whose insurance is self-funded but managed through Aetna. I actually made some progress or so I thought. I don't know all of what happened but I can tell you the "wellness" company which was also contracted and started understanding the benefits of afrezza got fired.
Why they got fired I am not really sure. I am sure there were other issues. What I do know is they had been tasked with ways to reduce costs and they told me diabetes was the biggest health cost driver. I was able to leverage some of the earlier VDex success stories plus a simple tag line; if you don't believe what VDex has in their white paper, try it yourself.
IMO, doctors are not going to change. They will add some new "exotic" drug like a GLP1 or SGLT2 which requires the PWD to ask more questions and have more reliance on the doctor and make the doctor feel more important and pay more money. Having them use afrezza and getting near non-diabetic results provides no value for the doctor. Its not a value proposition. Getting some free hand-outs from their old BP sales friends is.
The only thing which will get their attention is if you can hit them in the pocket. HMOs don't write the scripts the doctors do.
HMOs don’t write the scripts the doctors do.... and VDEX has doctors.
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Post by vdexdiabetes on Jan 8, 2019 10:23:40 GMT -5
Uvula, we treat both Type 1 and 2 patients, obviously many more twos than one.
Getting insurance coverage is difficult, and we certainly don't so much get coverage in place of metaformin, but in addition to it. Virtually all patients who come to us are uncontrolled (HbA1c well above 7) and on medication. Most patients are on metaformin and many of those are taking the maximum daily dose, 2000mg. In that case, because the patient is still uncontrolled, the physician needs another tool. We then have to work through the prior authorization process to get the Afrezza approved. Sometimes we succeed. Sometimes the insurance plan wants us to try some interim step like maybe a GLP. The physician has to fight for Afrezza.
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Post by uvula on Jan 8, 2019 10:39:24 GMT -5
Wow. So even if a doctor wants to put a "new" T2D on Afrezza, the insurance company will not allow it. Probably the only way to start a patient on Afrezza as the first medicine (with insurance coverage) is if the SOC puts Afrezza first. This will take a huge clinical study that MNKD will never be able to pay for by itself.
Places like VDEX can still be profitable because eventually all T2Ds will be eligible for Afrezza. But this certainly isn't best for the patients.
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