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Post by prcgorman2 on Jul 10, 2021 8:22:04 GMT -5
Yep. The horse is finally getting out of the barn and it's hard to imagine what BP is going to do about it...other than make a play! I always thought it was the cow that got out of the barn, the cat got out of the bag, and the rooster came home to roost. But I’ll take horses, cows, cats, or roosters if it means Mannkind may finally be growing some teeth, or is it growing a pair? I like your avatar goyocafe. An African Grey parrot may be the smartest bird in the world. One once saved the life of my uncle’s accountant. True story. She was working late and an intruder broke in and tried to harm her, and the parrot mimicked in perfect language and sounding exactly like my uncle and the predator dashed away to escape what he thought was a man coming to the rescue. |
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Post by itellthefuture777 on Jul 11, 2021 10:21:54 GMT -5
I would change her message a little...to.."Meal times are 12% of your day, and where diabetics start to lose control. Why not enjoy them in range? Afrezza |
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Post by agedhippie on Jul 15, 2021 10:12:52 GMT -5
Where’s agedhippie when you need him? I don’t think those are arguments or incompatible even if they were. I’ve seen more than one post from PWDs where they talk about using both RAA and Afrezza, and that makes perfect sense to me; Afrezza for first phase, and a lower dose of RAA with perhaps an additional (lower?) dose of Afrezza for spikes. The “argument” for CGMs and loops alike is control and time in range. What the pump lacks is knowledge of a meal the PWD is about to consume and a reservoir of non-RAA human insulin that it can inject directly into the bloodstream. Afrezza can fill that gap. My wife’s T1 uncle who passed away from COVID early this year used to visit at family gatherings and when he was looking at goodies for dessert he would adjust his pump, but it’s the wrong juice or not the best approach I guess I would say. At least, that’s what I’ve understood from PWDs who’ve posted and know much better than I do. I don't disagree with anything you wrote, but it doesn't seem to be a response to what I wrote. By definition, closed loop means the person isn't part of the control system. The companies selling AP don't want to admit that they need help from inhaled insulin. The Aged one would probably say an AP without afrezza is good enough for most T1Ds, and would be much better than most T1Ds are doing today. The answer to your where is agedhippie is "still occasionally lurking".  You do squarely hit the nail on the head though, the aim is zero intervention with the AP being an AP and not a glorified pump. This is why the whole discussion on Dexcom, CGMs in general, and Medtronics is irrelevant. Their target is the fire an forget market - connect up and get on with your life. Ultimately the only thing interested in your CGM should be your AP. That's a pipedream at this point although they are getting closer. That said, the 780G in a recent report over 4,000 users hit 76.2% TIR which is pretty good. The pump makers have been investing in auto meal detection and bolusing for a couple of years now but nothing has been published but it's obviously where they are heading. |
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Post by sayhey24 on Jul 15, 2021 19:11:39 GMT -5
The big market for DXCM and Medtronics and other CGM vendors is not in the AP market or even the T1 market. Its the T2 market and now we just need to see how they approach it with the medicare policy change. As far as the AP, the issue is still the issue Al Mann set out to solve when he discovered afrezza. Its absorption. The RAAs are too damn slow at meal time and absorption is a changing variable. Until that problem is solved which won't be solved by new algorithms, APs work best when used with afrezza at meals. A little puff while you are eating is really no big deal. Its funny to see those doing AP research using as the baseline afrezza during meals. If their algorithms could be as good as the AP with afrezza then thats about as good as they would do.
Al was pretty convinced with afrezza, the need for the AP was OBE. He said a simple patch pump and afrezza was probably the way to go. But, lets not forget that Al saw afrezza as a near cure for the T2s.
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Post by porkini on Jul 15, 2021 19:33:03 GMT -5
The big market for DXCM and Medtronics and other CGM vendors is not in the AP market or even the T1 market. Its the T2 market and now we just need to see how they approach it with the medicare policy change. As far as the AP, the issue is still the issue Al Mann set out to solve when he discovered afrezza. Its absorption. The RAAs are too damn slow at meal time and absorption is a changing variable. Until that problem is solved which won't be solved by new algorithms, APs work best when used with afrezza at meals. A little puff while you are eating is really no big deal. Its funny to see those doing AP research using as the baseline afrezza during meals. If their algorithms could be as good as the AP with afrezza then thats about as good as they would do. Al was pretty convinced with afrezza, the need for the AP was OBE. He said a simple patch pump and afrezza was probably the way to go. But, lets not forget that Al saw afrezza as a near cure for the T2s. What OBE? Sorry, too much aphla soop.  Okay, let's pick one: OBE Order of the British Empire OBE Out of Body Experience OBE Oracle by Example (software) OBE On Board Experiential Marketing (various locations) OBE Outcome-Based Education OBE Optical Bloch Equations (physics) OBE Other Business Enterprise (classification) OBE Ocean Biogeochemistry and Ecosystems (joint venture; UK) OBE Online Booking Engine OBE Overcome By Events OBE Overtaken By Events OBE On-Board Equipment OBE Out before Easter OBE Operating-Basis Earthquake OBE Original Black Entertainment (British TV channel) OBE One Boson Exchange OBE Odontología Basada en la Evidencia OBE Office of Business Economics OBE Other Buggers Efforts OBE Our Best Estimate OBE Open Book Estimate OBE Omni Box Entertainment (gaming) OBE Over Bloody Eighty (gifts) OBE Our Best Effort OBE Open Book Examination OBE One Behind the Ear OBE Opening Balance Equity (finance) OBE On-Board Equivalent (NASA) OBE Online Bidding Event OBE Out-Board Electronics OBE Outboard Booster Engine OBE Office/Officer of the Order of the British Empire OBE Overall Boat Effectiveness OBE Overwhelmed by Events OBE Order of the Brown Envelope OBE Old But Everlasting I have a boat, so I pick "Overall Boat Effectiveness" Then again, I'm old... Old But Everlasting  |
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Post by Deleted on Jul 15, 2021 19:35:53 GMT -5
The big market for DXCM and Medtronics and other CGM vendors is not in the AP market or even the T1 market. Its the T2 market and now we just need to see how they approach it with the medicare policy change. As far as the AP, the issue is still the issue Al Mann set out to solve when he discovered afrezza. Its absorption. The RAAs are too damn slow at meal time and absorption is a changing variable. Until that problem is solved which won't be solved by new algorithms, APs work best when used with afrezza at meals. A little puff while you are eating is really no big deal. Its funny to see those doing AP research using as the baseline afrezza during meals. If their algorithms could be as good as the AP with afrezza then thats about as good as they would do. Al was pretty convinced with afrezza, the need for the AP was OBE. He said a simple patch pump and afrezza was probably the way to go. But, lets not forget that Al saw afrezza as a near cure for the T2s. Your analysis is good but you have to get to the root.....The SOC for Type 2's is FLAWED. I should say it's time to REFRESH them due to new treatments. The ADA and FDA (more so) have to change the protocols. With the low risk of Afrezza it's time for doctors to put T2's on it for better control. Right now the Treat to Failure is no longer a viable option. Now I don't know what it will take for MNKD or the FDA to change the protocols but they have to do it. And MNKD will have to lower the price which will come with higher volume. |
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Post by sayhey24 on Jul 16, 2021 7:43:55 GMT -5
You have to follow the money. Both the FDA and ADA are driven by the money but the ADA is taking those huge BP payments. Its also the ADA controlling the SoC and providing the recommendations for how the FDA should approve study protocol.
The afrezza Infinity studies evaluated A1c. Afrezza will never do better than other insulins with A1C especially if you have a tail on the RAAs and you don't take a follow-up afrezza dose when necessary. Nothing better for reducing A1C but to constantly be having hypos.
Getting near term major changes to the SoC is not going to happen. This would have to be supported by BP who are providing the money and it would totally disrupt the diabetes market. Afrezza is a disruptive technology and when used with a monitoring service and CGMs can change how T2s which are 90% of the market are treated.
The CGM vendors are now starting to move in the direction of TIR. The Abbott Libre TV commercials are now talking about stop guessing. One of the CGM vendors will take the lead maybe in partnership with a monitoring service. Its happening but its going to take a few more years. Its been a very long journey for afrezza but a couple years in a 20 year journey is not bad. Once CGM/monitoring become mainstream the current SoC and A1C will be OBE (over taken by events) and maybe the ADA will update it but at that point who cares.
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Post by agedhippie on Jul 18, 2021 22:08:18 GMT -5
The big market for DXCM and Medtronics and other CGM vendors is not in the AP market or even the T1 market. Its the T2 market and now we just need to see how they approach it with the medicare policy change. As far as the AP, the issue is still the issue Al Mann set out to solve when he discovered afrezza. Its absorption. The RAAs are too damn slow at meal time and absorption is a changing variable. Until that problem is solved which won't be solved by new algorithms, APs work best when used with afrezza at meals. A little puff while you are eating is really no big deal. Its funny to see those doing AP research using as the baseline afrezza during meals. If their algorithms could be as good as the AP with afrezza then thats about as good as they would do. Al was pretty convinced with afrezza, the need for the AP was OBE. He said a simple patch pump and afrezza was probably the way to go. But, lets not forget that Al saw afrezza as a near cure for the T2s. Al might have seen Afrezza as a near cure for Type 2 yet here we are years later and Mannkind management has still not been done to prove that. Until there is large scale trial data to support that claim it just remains a theory and nobody will act on it (other than VDEX). You cannot have Afrezza as part of an AP because an AP is meant to be zero touch and that rules out Afrezza as you both have to manually inhale, and also enter the fact into the AP system. That's not an AP, that's not even closed loop. It's hybrid which is where we are today. |
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Post by akemp3000 on Jul 19, 2021 6:24:53 GMT -5
IMO, the data from a large scale, expensive and time-consuming trial is no longer necessary because it will be trumped by the real-time results that diabetics will see when using Afrezza in conjunction with a CGM. Word will spread about the successful results seen by endos and Afrezza users. Add to this the forthcoming pediatric approval and parents everywhere will also be sharing the news and choosing inhalation over excessive needles for their children. Al believed an artificial pancreas would ultimately be too expensive and that using Afrezza either alone or in conjunction with a basal would become the world's simplest and best answer. It seems to be heading in that direction. It's difficult to see how BP's offering more expensive and less effective options are going to stop this from moving forward. We'll see.
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Post by uvula on Jul 19, 2021 8:39:52 GMT -5
If data are not from a clinical trial, when does anecdotal evidence become actual evidence in the eyes of the FDA? Can the noninferior label be updated to something better without an expensive clinical trial? Can a study be done of real time data from thousands of patients instead of a clinical study?
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Post by sayhey24 on Jul 19, 2021 10:04:42 GMT -5
Aged - I have to agree with akemp3000. The days of large studies for afrezza have been OBE with CGMs, monitoring services, etc. The covid vaccines helped change the large scale, long-term study model. More over, what is it we are going to learn about afrezza which we don't already know? Its human insulin which works pretty well when the pancreas releases it and afrezza very nearly mimics pancreatic release. After six years we have not seen any exploding's lungs which was the biggest concern and have actually seen improved lung function with some PWDS.
I can't imagine one BP which wants afrezza still on the market and everything including the kitchen sink, stove and refrigerator have been thrown at it. Some CGM vendor is going to decide they really want to be in the T2 market big time and to do that they are going to need to push TIR and afrezza. No study is needed for that. It just takes a business decision and money to disrupt the market. Maybe its in partnership with an IT company like a Google, Apple or IBM. The technology is now there to support this so its a matter of time. No study is required for this just a lot of money to get it going.
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Post by dh4mizzou on Jul 19, 2021 10:19:56 GMT -5
There is already a CGM that pushes TIR in their commercials. I will pay more attention so I can recall who it is.
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Post by sayhey24 on Jul 19, 2021 11:06:35 GMT -5
If data are not from a clinical trial, when does anecdotal evidence become actual evidence in the eyes of the FDA? Can the noninferior label be updated to something better without an expensive clinical trial? Can a study be done of real time data from thousands of patients instead of a clinical study? The ADA is controlling the SoC. The non-inferior label is for A1C. Do we care about A1c at this point? We know its a failed metric. Afrezza will never be better than any other insulin over a 24hr day for A1C especially when the other insulins are causing hypoglycemia. There is nothing better than a few hypos to reduce A1C. CGM vendors don't care about A1c. They care about TIR and AGPs. T2s are not prescribed insulin day 1 because of the hypo danger and needles. With the medicare policy change the barn doors are now open for a CGM vendor to take this bull by the horns. Someone will but no one, especially a Kevin Sayer needs another afrezza study. He was at Minimed with Al when this thing was discovered with Sol Steiner. |
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Post by ktim on Jul 29, 2021 21:09:10 GMT -5
The big market for DXCM and Medtronics and other CGM vendors is not in the AP market or even the T1 market. Its the T2 market and now we just need to see how they approach it with the medicare policy change. As far as the AP, the issue is still the issue Al Mann set out to solve when he discovered afrezza. Its absorption. The RAAs are too damn slow at meal time and absorption is a changing variable. Until that problem is solved which won't be solved by new algorithms, APs work best when used with afrezza at meals. A little puff while you are eating is really no big deal. Its funny to see those doing AP research using as the baseline afrezza during meals. If their algorithms could be as good as the AP with afrezza then thats about as good as they would do. Al was pretty convinced with afrezza, the need for the AP was OBE. He said a simple patch pump and afrezza was probably the way to go. But, lets not forget that Al saw afrezza as a near cure for the T2s. Al might have seen Afrezza as a near cure for Type 2 yet here we are years later and Mannkind management has still not been done to prove that. Until there is large scale trial data to support that claim it just remains a theory and nobody will act on it (other than VDEX). You cannot have Afrezza as part of an AP because an AP is meant to be zero touch and that rules out Afrezza as you both have to manually inhale, and also enter the fact into the AP system. That's not an AP, that's not even closed loop. It's hybrid which is where we are today. I'm curious whether the state of the art in AP development includes use of machine learning in the patient device. Making a distinction here that they could use machine learning to develop the model for (e.g. "meal detection") but once in the patient device it would be a traditional algorithm rather than one that further adapts using patient specific machine learning. If the AP were to use machine learning to adapt to each patient, that could accommodate use of Afrezza without notifying the AP with better results if patient is somewhat consistent with its use. Though that would likely be true for a patient adaptive system that they be somewhat consistent in eating habits in general. I do see that patient specific machine learning likely sends off safety/regulatory flares, so perhaps that isn't yet being seriously considered. |
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Post by lazyb767 on Jul 29, 2021 21:59:31 GMT -5
Mad Money Dexcom CEO Q3 results
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