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Post by mango on Sept 16, 2022 7:57:33 GMT -5
The Afrezza Trilemma
The “lemma” is a play on words with the unique situation we find ourselves in today. Afrezza faces difficult opposition and acceptance in the diabetes market. The below 3 effects are what I call the Afrezza Trilemma—three manifestations that will counteract the opposition and barriers we face. It will take time for these 3 to become successful, but when it happens they will together create a powerful, unstoppable force, each complimentary to one another, yet completely distinct from each other as well.
Heretofore you have heard of a dilemma, it’s time you are introduced to the trilemma. Here, we examine the three point system in the Afrezza market place that will eventually lead to ever increasing Afrezza Users over the long term.
1. Pediatrics. Afrezza Pediatrics Phase 3 clinical trial is ongoing and the estimated Primary Completion Date is April 2023 and the estimated Study Completion Date is April 2024. That means we have a good probability of FDA approval in late 2024. The FDA approval for Afrezza Pediatrics will immediately put us into an advantageous position previously unattainable to us. This will create a powerful uptick in Afrezza scrips as well as life long Afrezza Users.
2. CGMs. CGMs are the Achilles Heel of The Insulin Cartel. There is no hiding from real time blood sugar manipulation with insulin revealed by the CGM. CGM adoption will continue to grow as time in range becomes the new Gold Standard in assessing glucose homeostasis. With more Afrezza Users comes more CGM data posted to social media and beyond. CGMs don’t lie and The Insulin Cartel won’t be able to hide behind A1C for much longer.
3. Celebrities and Influencers. Nothing drives change and ideas like good advertising. The backbone of Afrezza advertisement will rely on the tried and true principle of word-of-mouth advertising—a key utility to organic growth that even VDex founder Bill McCullough advocates and believes in because of the success it is responsible for creating with his hair implant business. Having influential real-life Afrezza Users being a walking advertisement for Afrezza is as real as it gets. Currently, Afrezza is growing traction in this field of advertisement and I suspect it will grow in momentum and scale over time.
After Pediatric approval I believe we will witness a synergistic exchange amongst these three “lemmas,” each being very effective individually, but when fused together, creatd what will become known as the Afrezza Trilemma. Beginning in 2025 we will witness a dramatic rise in Afrezza scrips and have finally pivoted ourselves into an advantageous position in the diabetes market. The landscape for Afrezza will forever change beginning 2025.
Stay tuned 😎
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Post by cretin11 on Sept 16, 2022 9:08:53 GMT -5
TGIF
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Post by peppy on Sept 16, 2022 9:18:44 GMT -5
The Afrezza TrilemmaThe “lemma” is a play on words with the unique situation we find ourselves in today. Afrezza faces difficult opposition and acceptance in the diabetes market. The below 3 effects are what I call the Afrezza Trilemma—three manifestations that will counteract the opposition and barriers we face. It will take time for these 3 to become successful, but when it happens they will together create a powerful, unstoppable force, each complimentary to one another, yet completely distinct from each other as well. Heretofore you have heard of a dilemma, it’s time you are introduced to the trilemma. Here, we examine the three point system in the Afrezza market place that will eventually lead to ever increasing Afrezza Users over the long term. 1. Pediatrics. Afrezza Pediatrics Phase 3 clinical trial is ongoing and the estimated Primary Completion Date is April 2023 and the estimated Study Completion Date is April 2024. That means we have a good probability of FDA approval in late 2024. The FDA approval for Afrezza Pediatrics will immediately put us into an advantageous position previously unattainable to us. This will create a powerful uptick in Afrezza scrips as well as life long Afrezza Users. 2. CGMs. CGMs are the Achilles Heel of The Insulin Cartel. There is no hiding from real time blood sugar manipulation with insulin revealed by the CGM. CGM adoption will continue to grow as time in range becomes the new Gold Standard in assessing glucose homeostasis. With more Afrezza Users comes more CGM data posted to social media and beyond. CGMs don’t lie and The Insulin Cartel won’t be able to hide behind A1C for much longer. 3. Celebrities and Influencers. Nothing drives change and ideas like good advertising. The backbone of Afrezza advertisement will rely on the tried and true principle of word-of-mouth advertising—a key utility to organic growth that even VDex founder Bill McCullough advocates and believes in because of the success it is responsible for creating with his hair implant business. Having influential real-life Afrezza Users being a walking advertisement for Afrezza is as real as it gets. Currently, Afrezza is growing traction in this field of advertisement and I suspect it will grow in momentum and scale over time. After Pediatric approval I believe we will witness a synergistic exchange amongst these three “lemmas,” each being very effective individually, but when fused together, creatd what will become known as the Afrezza Trilemma. Beginning in 2025 we will witness a dramatic rise in Afrezza scrips and have finally pivoted ourselves into an advantageous position in the diabetes market. The landscape for Afrezza will forever change beginning 2025. Stay tuned 😎 Health care insurance coverage. Quadlemma. |
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Post by letitride on Sept 16, 2022 19:49:14 GMT -5
I believe before we get to a quadlemma there will be a buyout endalemmas.
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Post by prcgorman2 on Sept 19, 2022 13:33:06 GMT -5
The Afrezza TrilemmaThe “lemma” is a play on words with the unique situation we find ourselves in today. Afrezza faces difficult opposition and acceptance in the diabetes market. The below 3 effects are what I call the Afrezza Trilemma—three manifestations that will counteract the opposition and barriers we face. It will take time for these 3 to become successful, but when it happens they will together create a powerful, unstoppable force, each complimentary to one another, yet completely distinct from each other as well. Heretofore you have heard of a dilemma, it’s time you are introduced to the trilemma. Here, we examine the three point system in the Afrezza market place that will eventually lead to ever increasing Afrezza Users over the long term. 1. Pediatrics. Afrezza Pediatrics Phase 3 clinical trial is ongoing and the estimated Primary Completion Date is April 2023 and the estimated Study Completion Date is April 2024. That means we have a good probability of FDA approval in late 2024. The FDA approval for Afrezza Pediatrics will immediately put us into an advantageous position previously unattainable to us. This will create a powerful uptick in Afrezza scrips as well as life long Afrezza Users. 2. CGMs. CGMs are the Achilles Heel of The Insulin Cartel. There is no hiding from real time blood sugar manipulation with insulin revealed by the CGM. CGM adoption will continue to grow as time in range becomes the new Gold Standard in assessing glucose homeostasis. With more Afrezza Users comes more CGM data posted to social media and beyond. CGMs don’t lie and The Insulin Cartel won’t be able to hide behind A1C for much longer. 3. Celebrities and Influencers. Nothing drives change and ideas like good advertising. The backbone of Afrezza advertisement will rely on the tried and true principle of word-of-mouth advertising—a key utility to organic growth that even VDex founder Bill McCullough advocates and believes in because of the success it is responsible for creating with his hair implant business. Having influential real-life Afrezza Users being a walking advertisement for Afrezza is as real as it gets. Currently, Afrezza is growing traction in this field of advertisement and I suspect it will grow in momentum and scale over time. After Pediatric approval I believe we will witness a synergistic exchange amongst these three “lemmas,” each being very effective individually, but when fused together, creatd what will become known as the Afrezza Trilemma. Beginning in 2025 we will witness a dramatic rise in Afrezza scrips and have finally pivoted ourselves into an advantageous position in the diabetes market. The landscape for Afrezza will forever change beginning 2025. Stay tuned 😎 Nice, well-reasoned post.
What you described should help with reducing prescriber reluctance. The timing of FDA approval of Afrezza for pediatric use and possible (probable?) uptick in sales, especially for very young, needle averse T1 children (and their parents) sounds about right to me. The two biggest headwinds are prescriber reluctance and insurer reluctance. Fingers crossed 2025 sees significant improvement in both of those areas, and in sales as result. |
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Post by sayhey24 on Sept 19, 2022 15:05:28 GMT -5
Mango - I see things a little different. Afrezza adoption will go hand and hand with changes to the ADA's SoCs. As the SoCs change so will provider adoption and insurance adoption. Its also important to remember there are two separate markets for afrezza and two separate SoCs.
For the T1s I agree the kids are going to drive this. If afrezza can show that kids are getting results as good as their pumps and its as safe what mom is not going to want afrezza for their kid? Few kids want to be connected all day to a pump and then fuss with post prandial control. As the mom's drive afrezza usage the SoC will be required to change as results come in and the community has no choice to but recognize afrezza's value. When that happens insurance is no longer an issue and those cautious endo's will now prescribe. Let's keep in mind there are only about 2000 well defined prescribing endos.
For the T2s its a very different ball game. The market is 10x larger and its mostly GPs writing antiglycemic scripts. These GPs are blindly following the ADA's T2 SoC. Mike has to figure out his game plan here. CGMs can show all day long that none of the antiglycemics can address the principle issue T2s have and thats post prandial control. GLP1s can mask some of the spike by having the PWD eating a lot less and lengthening the digestive time but they are still only masking the issue. SGLT2 can't do a damn thing about the spike and we can see that all day long on the CGM. Sadly the pediatric results will have no impact here with the T2s. Neither will any celebrities. Its all about the T2 SoC. Thats what the GPs are taught in medical school and that is how they prescribe. Right now we/Mike have no T2 plan and the Trilemma is not going to help.
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Post by Chris-C on Sept 20, 2022 13:20:49 GMT -5
Mango - I see things a little different. Afrezza adoption will go hand and hand with changes to the ADA's SoCs. As the SoCs change so will provider adoption and insurance adoption. Its also important to remember there are two separate markets for afrezza and two separate SoCs. For the T1s I agree the kids are going to drive this. If afrezza can show that kids are getting results as good as their pumps and its as safe what mom is not going to want afrezza for their kid? Few kids want to be connected all day to a pump and then fuss with post prandial control. As the mom's drive afrezza usage the SoC will be required to change as results come in and the community has no choice to but recognize afrezza's value. When that happens insurance is no longer an issue and those cautious endo's will now prescribe. Let's keep in mind there are only about 2000 well defined prescribing endos. For the T2s its a very different ball game. The market is 10x larger and its mostly GPs writing antiglycemic scripts. These GPs are blindly following the ADA's T2 SoC. Mike has to figure out his game plan here. CGMs can show all day long that none of the antiglycemics can address the principle issue T2s have and thats post prandial control. GLP1s can mask some of the spike by having the PWD eating a lot less and lengthening the digestive time but they are still only masking the issue. SGLT2 can't do a damn thing about the spike and we can see that all day long on the CGM. Sadly the pediatric results will have no impact here with the T2s. Neither will any celebrities. Its all about the T2 SoC. Thats what the GPs are taught in medical school and that is how they prescribe. Right now we/Mike have no T2 plan and the Trilemma is not going to help. For all diabetics, as discussed here on occasion, a key variable for disease management is Time in Range (TIR). We are only seeing the crude beginnings of wearable biosensors and the Internet of Things (aka ubiquitous connectivity). With smarter and better CGMs, their use will increase and more Time in range comparisons and studies will be done. These will continue to show how problematic uncontrolled spikes and out of range excursions (including TBR) are for diabetes management. Two meta-analyses published in 2020 in the journal Diabetes demonstrated the value of GGMs in improving all Range relevant measures of glycemic control. A 2019 study by Beck in Diabetes Care concluded that TIR is strongly associated with reducing microvascular complications leading to Kidney disease, neuropathy leading to amputations and retinopathy leading to blindness. As long as people keep eating junk food and living on their couches, the incidence of diabetes and its preventable complications will increase. Meantime, it will be increasingly easier for folks to wear devices that can help them stay in range. Afrezza’s fast acting and short duration profile gives it an advantage over current insulin analogs. This makes achieving TIR goals easier and reduces the problem of hypos. Knowledge uptake will eventually result in recognition of the advantages of Afrezza and I heartily agree with those who advocate for the use of CGMs, especially as they come down in price. Who knows? The Apple Watch of 2025 may have an optional GGM feature! This technology will appear, the only question is when? Regards to all Chris C |
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Post by sayhey24 on Sept 20, 2022 17:42:42 GMT -5
Mango - I see things a little different. Afrezza adoption will go hand and hand with changes to the ADA's SoCs. As the SoCs change so will provider adoption and insurance adoption. Its also important to remember there are two separate markets for afrezza and two separate SoCs. For the T1s I agree the kids are going to drive this. If afrezza can show that kids are getting results as good as their pumps and its as safe what mom is not going to want afrezza for their kid? Few kids want to be connected all day to a pump and then fuss with post prandial control. As the mom's drive afrezza usage the SoC will be required to change as results come in and the community has no choice to but recognize afrezza's value. When that happens insurance is no longer an issue and those cautious endo's will now prescribe. Let's keep in mind there are only about 2000 well defined prescribing endos. For the T2s its a very different ball game. The market is 10x larger and its mostly GPs writing antiglycemic scripts. These GPs are blindly following the ADA's T2 SoC. Mike has to figure out his game plan here. CGMs can show all day long that none of the antiglycemics can address the principle issue T2s have and thats post prandial control. GLP1s can mask some of the spike by having the PWD eating a lot less and lengthening the digestive time but they are still only masking the issue. SGLT2 can't do a damn thing about the spike and we can see that all day long on the CGM. Sadly the pediatric results will have no impact here with the T2s. Neither will any celebrities. Its all about the T2 SoC. Thats what the GPs are taught in medical school and that is how they prescribe. Right now we/Mike have no T2 plan and the Trilemma is not going to help. For all diabetics, as discussed here on occasion, a key variable for disease management is Time in Range (TIR). We are only seeing the crude beginnings of wearable biosensors and the Internet of Things (aka ubiquitous connectivity). With smarter and better CGMs, their use will increase and more Time in range comparisons and studies will be done. These will continue to show how problematic uncontrolled spikes and out of range excursions (including TBR) are for diabetes management. Two meta-analyses published in 2020 in the journal Diabetes demonstrated the value of GGMs in improving all Range relevant measures of glycemic control. A 2019 study by Beck in Diabetes Care concluded that TIR is strongly associated with reducing microvascular complications leading to Kidney disease, neuropathy leading to amputations and retinopathy leading to blindness. As long as people keep eating junk food and living on their couches, the incidence of diabetes and its preventable complications will increase. Meantime, it will be increasingly easier for folks to wear devices that can help them stay in range. Afrezza’s fast acting and short duration profile gives it an advantage over current insulin analogs. This makes achieving TIR goals easier and reduces the problem of hypos. Knowledge uptake will eventually result in recognition of the advantages of Afrezza and I heartily agree with those who advocate for the use of CGMs, especially as they come down in price. Who knows? The Apple Watch of 2025 may have an optional GGM feature! This technology will appear, the only question is when? Regards to all Chris C TIR is nice but most T2s have never been told to even measure their BG once a day by their GP. I have gone to too many educational sessions for T2s. Its the same answer all the time that most have never even been told by their GP to do daily measurements. Heck - most don't even own a meter and these are people who are voluntarily signing up for a night course on their own time because they want to learn more about T2. By now I would have hoped all new T2s were put on a CGM. To me that sounds like a sensible thing to do as step 1. Nope - Section 7 of the SoC says - " In people with type 2 diabetes not using insulin, routine glucose monitoring may be of limited additional clinical benefit. By itself, even when combined with education, it has showed limited improvement in outcomes". Of course that is true because the antiglycemics can't stop the post meal spike. They can't replace the insulin the body is not making. The body needs insulin, it does not need the body pissing out excess sugar once their BG level is through the roof. Heck - if T2s are given CGMs and they start seeing whats happening they are going to start asking questions and that is the last thing the community wants. The community needs T2s to be kept in the dark or they will see their antiglycemics are a waste of time. When I first met Mike I told him CGMs and technology would save afrezza. We are seeing this play out with the kids and T1s. I think we have been talking about TIR and connected care on this board before most even heard of it. What we have know for a long time is junk food does not cause diabetes. What causes high BG is the body is not making enough insulin for its needs. What the tech diet companies have seen and shocked a little is that the "diabetic weight" happens after their client loses post prandial control. Can you starve this new T2 diabetic - sure. We do it with GLP1s today but we also see after about 18 months their BG levels start to rise if they stay on the GLP1 that long as most don't. In the next few years CGMs for the T2 community will not change the T2 SoC. If Apple comes out with their Apple "CGM" watch and watching post meal BG becomes ubiquitous then the conversation will change and everyone will become an overnight expert in post prandial BG. Everyone will know that spiking way past 140 is not good. They will see their metformin is doing nothing to stop the spike. The reality is this is not happening for a long time. I wish I was wrong. For the foreseeable future the T2 SoC is going to drive what GPs prescribe for the T2s. To sell afrezza into this HUGE market Mike needs a plan. Waiting for the results of the India study is not going to do it. We already have the Affinity-2 results and I would be shocked if the India results do little more than mimic these results showing afrezza being superior over current treatments. Maybe step 1 in changing the T2 SoC is getting it to say all new T2s should be put on a CGM day 1. I am sure DXCM and Abbott would be OK with that. Pfizer, Novo Nordisk and Merck won't be too happy. |
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Post by centralcoastinvestor on Sept 20, 2022 20:06:03 GMT -5
For all diabetics, as discussed here on occasion, a key variable for disease management is Time in Range (TIR). We are only seeing the crude beginnings of wearable biosensors and the Internet of Things (aka ubiquitous connectivity). With smarter and better CGMs, their use will increase and more Time in range comparisons and studies will be done. These will continue to show how problematic uncontrolled spikes and out of range excursions (including TBR) are for diabetes management. Two meta-analyses published in 2020 in the journal Diabetes demonstrated the value of GGMs in improving all Range relevant measures of glycemic control. A 2019 study by Beck in Diabetes Care concluded that TIR is strongly associated with reducing microvascular complications leading to Kidney disease, neuropathy leading to amputations and retinopathy leading to blindness. As long as people keep eating junk food and living on their couches, the incidence of diabetes and its preventable complications will increase. Meantime, it will be increasingly easier for folks to wear devices that can help them stay in range. Afrezza’s fast acting and short duration profile gives it an advantage over current insulin analogs. This makes achieving TIR goals easier and reduces the problem of hypos. Knowledge uptake will eventually result in recognition of the advantages of Afrezza and I heartily agree with those who advocate for the use of CGMs, especially as they come down in price. Who knows? The Apple Watch of 2025 may have an optional GGM feature! This technology will appear, the only question is when? Regards to all Chris C TIR is nice but most T2s have never been told to even measure their BG once a day by their GP. I have gone to too many educational sessions for T2s. Its the same answer all the time that most have never even been told by their GP to do daily measurements. Heck - most don't even own a meter and these are people who are voluntarily signing up for a night course on their own time because they want to learn more about T2. By now I would have hoped all new T2s were put on a CGM. To me that sounds like a sensible thing to do as step 1. Nope - Section 7 of the SoC says - " In people with type 2 diabetes not using insulin, routine glucose monitoring may be of limited additional clinical benefit. By itself, even when combined with education, it has showed limited improvement in outcomes". Of course that is true because the antiglycemics can't stop the post meal spike. They can't replace the insulin the body is not making. The body needs insulin, it does not need the body pissing out excess sugar once their BG level is through the roof. Heck - if T2s are given CGMs and they start seeing whats happening they are going to start asking questions and that is the last thing the community wants. The community needs T2s to be kept in the dark or they will see their antiglycemics are a waste of time. When I first met Mike I told him CGMs and technology would save afrezza. We are seeing this play out with the kids and T1s. I think we have been talking about TIR and connected care on this board before most even heard of it. What we have know for a long time is junk food does not cause diabetes. What causes high BG is the body is not making enough insulin for its needs. What the tech diet companies have seen and shocked a little is that the "diabetic weight" happens after their client loses post prandial control. Can you starve this new T2 diabetic - sure. We do it with GLP1s today but we also see after about 18 months their BG levels start to rise if they stay on the GLP1 that long as most don't. In the next few years CGMs for the T2 community will not change the T2 SoC. If Apple comes out with their Apple "CGM" watch and watching post meal BG becomes ubiquitous then the conversation will change and everyone will become an overnight expert in post prandial BG. Everyone will know that spiking way past 140 is not good. They will see their metformin is doing nothing to stop the spike. The reality is this is not happening for a long time. I wish I was wrong. For the foreseeable future the T2 SoC is going to drive what GPs prescribe for the T2s. To sell afrezza into this HUGE market Mike needs a plan. Waiting for the results of the India study is not going to do it. We already have the Affinity-2 results and I would be shocked if the India results do little more than mimic these results showing afrezza being superior over current treatments. Maybe step 1 in changing the T2 SoC is getting it to say all new T2s should be put on a CGM day 1. I am sure DXCM and Abbott would be OK with that. Pfizer, Novo Nordisk and Merck won't be too happy. Great write up. I think you are spot on. I would add, that I believe that Mike is taking the best approach in going after T1s, particularly Peds after approval. MannKind cannot fight the whole Diabetes Industrial Complex when it comes to T2s. We would go bankrupt attempting to do so. So I like our current approach. Get Peds approval and become the insulin of choice for T1s. Then Apple comes out with a watch that measures BG and we are off to the races. How long that will take? Who knows. |
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Post by sayhey24 on Sept 21, 2022 17:54:28 GMT -5
I think Mike could and should be doing more in the T2 space. Maybe he is and I hope he is but Al Mann invested his $1B in afrezza because he saw it as a near cure for T2s. Crazy as I may be, I think Al was correct.
Lets face it, Mike going into an ADA meeting and demanding afrezza should be step 1 in the T2 SoC is not going to work. Dave Kendall thought this was going to be easily done. Mike also spent $6M on the epic "Seeing is Believing" campaign. What they spent the money on and exactly what they tried to do is a closely held secret. What we do know is it was an epic fail and Mike pulled the plug. What we also know is Mike never took me up on my offer to take my megaphone to ADA2022 and MC live "Seeing if Believing" demos. I even offered to buy my own ticket.
Chris C says TIR is going to save the day. OK, to do that you have to measure BG. The best way to do that is with a CGM. However the current SOC says "In people with type 2 diabetes not using insulin, routine glucose monitoring may be of limited additional clinical benefit. By itself, even when combined with education, it has showed limited improvement in outcomes". Is that true if CGMs are used and maybe a "coach" is added? Is the SoC provably wrong on this point?
Can Mike do something with that on the cheap? I am seeing DXCM TV commercials with T2s saying using a CGM lowered their A1C significantly. Are these commercials correct or is the SoC correct? I sure think it would be to DXCMs benefit if the SoC said all new T2s should be monitored with a CGM for some period of time. Maybe Mike can pick up the phone and try and get Kevin Sayer to fund a CGM study which defends his TV commercial and which can be taken to the ADA to change the SoC. Maybe as one arm of that study afrezza is included. I bet the afrezza arm will outperform the CGM only arm. Is that something which can be done right now which would cost MNKD nothing but which may have huge benefits in moving afrezza into the SoC? Can we do that while we wait for the kids and the India results?
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Post by agedhippie on Sept 22, 2022 10:21:17 GMT -5
... Chris C says TIR is going to save the day. OK, to do that you have to measure BG. The best way to do that is with a CGM. However the current SOC says "In people with type 2 diabetes not using insulin, routine glucose monitoring may be of limited additional clinical benefit. By itself, even when combined with education, it has showed limited improvement in outcomes". Is that true if CGMs are used and maybe a "coach" is added? Is the SoC provably wrong on this point? ... Maybe Mike can pick up the phone and try and get Kevin Sayer to fund a CGM study which defends his TV commercial and which can be taken to the ADA to change the SoC. Maybe as one arm of that study afrezza is included. I bet the afrezza arm will outperform the CGM only arm. Is that something which can be done right now which would cost MNKD nothing but which may have huge benefits in moving afrezza into the SoC? Can we do that while we wait for the kids and the India results? Dexcom are campaigning heavily for TIR and also Type 2 (but only for insulin users). Dexcom have the results from the MOBILE trial to support the use of a CGM over a meter for insulin using Type 2 (including those using just basal) and that provides the supporting evidence for the commercials by Type 2. I cannot see Dexcom funding an Afrezza arm in a trial, there is no benefit for them and it would just confuse the trial objective not to mention being added expense for Dexcom. |
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Post by prcgorman2 on Sept 22, 2022 12:08:34 GMT -5
Maybe Consumer Reports should do an evaluation of CGMs and insulins...
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Post by sayhey24 on Sept 22, 2022 13:44:38 GMT -5
... Chris C says TIR is going to save the day. OK, to do that you have to measure BG. The best way to do that is with a CGM. However the current SOC says "In people with type 2 diabetes not using insulin, routine glucose monitoring may be of limited additional clinical benefit. By itself, even when combined with education, it has showed limited improvement in outcomes". Is that true if CGMs are used and maybe a "coach" is added? Is the SoC provably wrong on this point? ... Maybe Mike can pick up the phone and try and get Kevin Sayer to fund a CGM study which defends his TV commercial and which can be taken to the ADA to change the SoC. Maybe as one arm of that study afrezza is included. I bet the afrezza arm will outperform the CGM only arm. Is that something which can be done right now which would cost MNKD nothing but which may have huge benefits in moving afrezza into the SoC? Can we do that while we wait for the kids and the India results? Dexcom are campaigning heavily for TIR and also Type 2 (but only for insulin users). Dexcom have the results from the MOBILE trial to support the use of a CGM over a meter for insulin using Type 2 (including those using just basal) and that provides the supporting evidence for the commercials by Type 2. I cannot see Dexcom funding an Afrezza arm in a trial, there is no benefit for them and it would just confuse the trial objective not to mention being added expense for Dexcom. If its only for insulin users, you could have fooled me - here is the commercial they are running www.ispot.tv/ad/q93a/dexcom-g6-too-many-times-sampleI never hear the word insulin. Will a CGM provide the results these people are claiming if they are not on insulin? I don't know. Dexcom sure says they are but the SoC says "routine glucose monitoring may be of limited additional clinical benefit". What is clear is that if the SoC said all new T2s should be put on a CGM that would be huge for Kevin Sayer. Now you ask why would Sayer fund an afrezza arm? Why should he. Why can't Mike offer to fund it. I bet afrezza would kick butt when paired with the G6. We know what Kevin said about afrezza when interviewed years ago - "I have never seen anything like it". My guess is he has still never seen anything like it. He also should at some point throw MNKD a bone. Kevin was there when afrezza was first developed by Al Mann and Sol. Al invented the CGM which Kevin is now selling. If Martine can throw MNKD a bone and a hand-up, I think Kevin can throw them 2 or 3 and give them a big huge. |
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Post by prcgorman2 on Sept 22, 2022 15:10:57 GMT -5
I remember proposing an idea for "The Afrezza Challenge" to Rose Alinaya where two groups of physicians and diabetics would compete for best results using appropriate protocols. One group was the Afrezza group. Didn't care who the non-Afrezza group would be, they would get smoked regardless. A nice prize would be handed out to the winners. Something like longer life and less neuropathy and deaths from hypos. (Just kidding about that last part.)
I get the FDA would never approve of that as a valid trial, but is the FDA's approval required? It's basically the "Seeing is believing" promotion the way sayhey wanted to do it.
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Post by agedhippie on Sept 22, 2022 15:57:41 GMT -5
Dexcom are campaigning heavily for TIR and also Type 2 (but only for insulin users). Dexcom have the results from the MOBILE trial to support the use of a CGM over a meter for insulin using Type 2 (including those using just basal) and that provides the supporting evidence for the commercials by Type 2. I cannot see Dexcom funding an Afrezza arm in a trial, there is no benefit for them and it would just confuse the trial objective not to mention being added expense for Dexcom. If its only for insulin users, you could have fooled me - here is the commercial they are running www.ispot.tv/ad/q93a/dexcom-g6-too-many-times-sampleI never hear the word insulin. Will a CGM provide the results these people are claiming if they are not on insulin? I don't know. Dexcom sure says they are but the SoC says "routine glucose monitoring may be of limited additional clinical benefit". What is clear is that if the SoC said all new T2s should be put on a CGM that would be huge for Kevin Sayer. Now you ask why would Sayer fund an afrezza arm? Why should he. Why can't Mike offer to fund it. I bet afrezza would kick butt when paired with the G6. We know what Kevin said about afrezza when interviewed years ago - "I have never seen anything like it". My guess is he has still never seen anything like it. He also should at some point throw MNKD a bone. Kevin was there when afrezza was first developed by Al Mann and Sol. Al invented the CGM which Kevin is now selling. If Martine can throw MNKD a bone and a hand-up, I think Kevin can throw them 2 or 3 and give them a big huge. Have a look at the link that they are pushing you to in the advert ( www.dexcom/BetterWay around 20 seconds in). This is not to say that you couldn't get a doctor to prescribe you a Dexcom, but if you did and were not on MDI you are not going struggle to get insurance cover and Dexcom know that hence the focus of the page they point you at. Kevin Sayer would love all Type 2 to be on a Dexcom and he is working towards that. It used to be that insulin using Type 2 could not get a CGM, now they can. They are working on getting the SoC widened but it's an incremental (Type 1 hypo unaware -> all Type 1 -> all Type 2 MDI -> Type 2 basal only -> ...), but it takes large scale trial data at each step of the way and that takes time. The benefit from Kevin's point of view to this approach is that the insurers have to follow - no trial data == no insurance coverage. There is no way Kevin Sayer can place the interests of Mannkind over his own shareholders, that's a lawsuit waiting to happen. Likewise Martine didn't throw Mannkind a bone (or I missed it). Rather she struck a commercial deal with Mannkind and side stepped the need to have to develop or buy a DPI maker. Al Mann sold the technology, along with his company, to Medtronics for a very good price. Dexcom was set up in competition to Medtronics and I seriously doubt they feel any debt to Mannkind. |
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