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Post by sayhey24 on Sept 30, 2022 11:17:54 GMT -5
... The thing with VDex is you are not following the ADA's SoC. You are following the VDex SoC. This is clearly a better SoC based on your PWD's results. How do we get other doctors to use your SoC? Can anything be done to pick-up the pieces from the failed "Seeing is Believing" campaign? Mostly you won't get doctors to change because the ADA SoC is seen as a very well sourced consensus view (which it is). It provides a panel of experts in the field all saying this is what you should do. However, doctors are at liberty to modify or ignore the SoC if they think they have a better treatment - it just tends to be very rare. What you are saying is true but at one time the earth being flat was also a well sourced consensus view. If we are to believe VDex and their results its clear the ADA's panel of experts have a lot to learn. The question is how can VDex's SoC become the mainstream SoC? With that said Bill and VDex are not doing much more than following through on what Al Mann believed. I believe VDex has a significantly better SoC than the ADA. What is also clear to me is BP control's the ADA and disrupting the $40B antiglycemic market is a tall order. So how can it be done? I think it will take more than large studies.
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Post by prcgorman2 on Sept 30, 2022 14:32:52 GMT -5
As the holders of the Holy Grail of Diabetes it’s our responsibility and duty to see Afrezza permeates within the medical community and becomes the Gold Standard in Mealtime Therapy. It’s time to use our newly acquired funds to launch multiple large scale, long term clinical trials which will have key elements in the Primary and Secondary Outcome Measures that will exploit and highlight Afrezza’s best attributes, which will in turn forever change the landscape of diabetes care. We need a large scale, long term STAT clinical trial with 400+ participants and run 1-1.5 years. Superiority trial. We need a Landmark Hypoglycemia clinical trial showing Afrezza is the safest insulin on the market. Large scale, long term clinical trial. Superiority trial. We need a large scale, long term clinical trial in Type 2 Diabetes highlighting early intervention with Afrezza to become the Gold Standard in T2D. We need 1000+ participants and this also needs to be 52+ weeks. Superiority trial. It’s time to call michaelcastagna into action. I like everything you said except for, "It's time to use our newly acquired funds". You may be right, but I don't know because I don't know what labor resources and other costs are involved in doing the things you said that I did agree with. It may be time, but that's dependent on costs and Mannkind's ability to bear them. If money were of no concern, I don't think Dr. Castagna would blink an eye at engaging in all of those activities, and more. One of the things I like about Mike is his conservative approach to managing the company. "Rest and grow" was a gaffe, but careful attention to debt, income, and expenses is something he's managed well IMHO. Instead of "Rest and grow", he should have said, "Steady as she goes", but whether he said it or not, that does seem to be his management style. I'm sure Mike is looking forward to when he can give the order for "full speed ahead" (or I also like, "Ramming speed!" or even "Ludicrous speed!") but I don't know if we're there yet.
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Post by agedhippie on Sept 30, 2022 15:51:47 GMT -5
Mostly you won't get doctors to change because the ADA SoC is seen as a very well sourced consensus view (which it is). It provides a panel of experts in the field all saying this is what you should do. However, doctors are at liberty to modify or ignore the SoC if they think they have a better treatment - it just tends to be very rare. I think I have noticed a pattern, The board talks about Afrezza prescriptions numbers, and Aged comes on line and saids, NOPE. It is never the system that is wrong. We seem to be the tiger, caught by the toe. The worlds best acting meal time insulin stopped by protocols. The issue is that complaining about the system is like complaining about the weather - you might not like it but it is what it is. Is the system wrong? That's irrelevant. How can you use the system to your advantage? Now that is the real question. That's why I don't waste time grumbling that the system is wrong (which it is btw).
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Post by pbaumgarten on Sept 30, 2022 16:17:38 GMT -5
My own opinion at this point is, it's been on the market seven years and simply hasn't caught on. It's been presented at conferences, tweeted about, blogged about, etc, etc. Between that and simple word of mouth, if it hasn't made it by now, then odds are not much else is going to help.
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Post by sayhey24 on Sept 30, 2022 18:33:55 GMT -5
My own opinion at this point is, it's been on the market seven years and simply hasn't caught on. It's been presented at conferences, tweeted about, blogged about, etc, etc. Between that and simple word of mouth, if it hasn't made it by now, then odds are not much else is going to help. How long was metformin on the market before it caught on, 50 years? How about the cell phone, 10+ years? Afrezza is the greatest advance in diabetes care since Banting and Best. There is a reason Al Mann put $1B of his own money into it. Its a matter of finding the right angle to change the SoC.
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Post by sayhey24 on Sept 30, 2022 18:46:27 GMT -5
I think I have noticed a pattern, The board talks about Afrezza prescriptions numbers, and Aged comes on line and saids, NOPE. It is never the system that is wrong. We seem to be the tiger, caught by the toe. The worlds best acting meal time insulin stopped by protocols. The issue is that complaining about the system is like complaining about the weather - you might not like it but it is what it is. Is the system wrong? That's irrelevant. How can you use the system to your advantage? Now that is the real question. That's why I don't waste time grumbling that the system is wrong (which it is btw). This is a message board. We are suppose to complain. The SoC is not the weather. Man can not change the weather, be it having the sun shine, stopping a hurricane or coming out of an ice age. Man can and will be change the SoC. Mike's job is to get it changed. He has a model with VDex. They have an SoC which is significantly better than the ADA's based on outcomes. Hopefully Mike comes up with a plan for the T2s soon.
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Post by peppy on Sept 30, 2022 19:38:28 GMT -5
The issue is that complaining about the system is like complaining about the weather - you might not like it but it is what it is. Is the system wrong? That's irrelevant. How can you use the system to your advantage? Now that is the real question. That's why I don't waste time grumbling that the system is wrong (which it is btw). This is a message board. We are suppose to complain. The SoC is not the weather. Man can not change the weather, be it having the sun shine, stopping a hurricane or coming out of an ice age. Man can and will be change the SoC. Mike's job is to get it changed. He has a model with VDex. They have an SoC which is significantly better than the ADA's based on outcomes. Hopefully Mike comes up with a plan for the T2s soon. If insurance companies were made to cover comparators rather than being able to choose the comparable medication they choose to cover, type 1's and their physicians would choose Afrezza, is my base case.
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Post by cretin11 on Sept 30, 2022 20:04:11 GMT -5
My own opinion at this point is, it's been on the market seven years and simply hasn't caught on. It's been presented at conferences, tweeted about, blogged about, etc, etc. Between that and simple word of mouth, if it hasn't made it by now, then odds are not much else is going to help. How long was metformin on the market before it caught on, 50 years? How about the cell phone, 10+ years? Exactly! Heck, when the Sumarians invented the wheel in ancient Mesopotamia, who knew it would be almost 6,000 years before Enzo Ferrari would create his Ferrari 125 S? Patience everyone! (We actually have the Ferrari of insulin, just need to have the right driver 😜)
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Post by prcgorman2 on Oct 1, 2022 8:19:20 GMT -5
We also have the Eddie Haskell of posters.
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Post by agedhippie on Oct 1, 2022 8:54:02 GMT -5
This is a message board. We are suppose to complain. The SoC is not the weather. Man can not change the weather, be it having the sun shine, stopping a hurricane or coming out of an ice age. Man can and will be change the SoC. Mike's job is to get it changed. He has a model with VDex. They have an SoC which is significantly better than the ADA's based on outcomes. Hopefully Mike comes up with a plan for the T2s soon. If insurance companies were made to cover comparators rather than being able to choose the comparable medication they choose to cover, type 1's and their physicians would choose Afrezza, is my base case. You cannot do that because it would allow the drug companies to set any price they wanted. Everything would devolve to the marketing to the consumer who wouldn't care because the insurer was paying the bulk of the bill. I have some sympathy with the approach though because I hate it when the PBM swaps between insulins on me, and they offer awful meters so I end up having to buy my own test strips.
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Post by peppy on Oct 1, 2022 12:19:47 GMT -5
If insurance companies were made to cover comparators rather than being able to choose the comparable medication they choose to cover, type 1's and their physicians would choose Afrezza, is my base case. You cannot do that because it would allow the drug companies to set any price they wanted. Everything would devolve to the marketing to the consumer who wouldn't care because the insurer was paying the bulk of the bill. I have some sympathy with the approach though because I hate it when the PBM swaps between insulins on me, and they offer awful meters so I end up having to buy my own test strips. We already have that in the USA.
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Post by agedhippie on Oct 1, 2022 17:53:37 GMT -5
You cannot do that because it would allow the drug companies to set any price they wanted. Everything would devolve to the marketing to the consumer who wouldn't care because the insurer was paying the bulk of the bill. I have some sympathy with the approach though because I hate it when the PBM swaps between insulins on me, and they offer awful meters so I end up having to buy my own test strips. We already have that in the USA. I agree except that the today insurers can negotiate down the price by offering exclusivity. If they were obliged to offer everything then they couldn't negotiate since they would be legally obliged to offer it. I suppose they could create a tier to dump all the drugs they didn't want to offer into and apply a terrible co-pay (you are liable for 99.99% of the drug cost for example). You can get any FDA approved drug today if you are prepared to bear the entire cost yourself, hence the pharmacy deal Mannkind has for Afrezza. To be clear, I am no fan of the US insurance system.
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Post by sayhey24 on Oct 2, 2022 12:53:44 GMT -5
This is a message board. We are suppose to complain. The SoC is not the weather. Man can not change the weather, be it having the sun shine, stopping a hurricane or coming out of an ice age. Man can and will be change the SoC. Mike's job is to get it changed. He has a model with VDex. They have an SoC which is significantly better than the ADA's based on outcomes. Hopefully Mike comes up with a plan for the T2s soon. If insurance companies were made to cover comparators rather than being able to choose the comparable medication they choose to cover, type 1's and their physicians would choose Afrezza, is my base case. Peppy - I could be wrong but I am convinced that is afrezza had its proper place in the SoC then insurance companies would cover it. I also think doctor are not prescribing because it is not the SoC. I think Dave Kendall had it right. Hopefully he shared some lessons learned with Mike.
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Post by agedhippie on Oct 2, 2022 13:09:31 GMT -5
If insurance companies were made to cover comparators rather than being able to choose the comparable medication they choose to cover, type 1's and their physicians would choose Afrezza, is my base case. Peppy - I could be wrong but I am convinced that is afrezza had its proper place in the SoC then insurance companies would cover it. I also think doctor are not prescribing because it is not the SoC. I think Dave Kendall had it right. Hopefully he shared some lessons learned with Mike. Afrezza is in the SoC, there is a subsection on inhaled insulin for Type 2. The problem you run into is the supporting evidence for the claims. As an example: A pilot study found evidence that compared with injectable rapid-acting insulin, supplemental doses of inhaled insulin taken based on postprandial glucose levels may improve blood glucose management without additional hypoglycemia or weight gain, although results from a larger study are needed for confirmation. What that says to the reader is that it may have these benefits, but who knows because there is insufficient trial data. The immediate response is to wait and see. This comes back to my constant theme - large scale trials to prove that the theories are real. No trials == no change.
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Post by sayhey24 on Oct 2, 2022 16:11:07 GMT -5
Peppy - I could be wrong but I am convinced that is afrezza had its proper place in the SoC then insurance companies would cover it. I also think doctor are not prescribing because it is not the SoC. I think Dave Kendall had it right. Hopefully he shared some lessons learned with Mike. Afrezza is in the SoC, there is a subsection on inhaled insulin for Type 2. The problem you run into is the supporting evidence for the claims. As an example: A pilot study found evidence that compared with injectable rapid-acting insulin, supplemental doses of inhaled insulin taken based on postprandial glucose levels may improve blood glucose management without additional hypoglycemia or weight gain, although results from a larger study are needed for confirmation. What that says to the reader is that it may have these benefits, but who knows because there is insufficient trial data. The immediate response is to wait and see. This comes back to my constant theme - large scale trials to prove that the theories are real. No trials == no change. Aged - I think I said "proper" - if "afrezza had its proper place in the SoC". I think we agree Mike needs to get some trials done. First, Mike needs a plan. The problem is if you look at figure 9.4 where is afrezza? The subsection you mention is under insulin therapy. Really, is afrezza just another insulin and gets a subsection??? There my friend is the issue. Agrezza is a game changer. Afrezza should be the first thing in figure 9.3 and then there would be no need for figure 9.4. That is Mike's job. When he does that we are $100+pps but more likely $500+pps. The good news is the community is starting to feel pressure to recognize afrezza. The kids study will help more.
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