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Post by agedhippie on May 22, 2022 16:50:36 GMT -5
Aged - this is where Al Mann was headed. He was looking for a faster insulin to put in his pumps. I think we are at about the limits of pumps and algorithms until there is a faster insulin and thats really hard because you have variables like insulin absorption. Afrezza on the other handle simplifies the mealtime spike and is very consistent. The pump can then do its thing. The AP and afrezza are not competitive devices. If the AP is used correctly and programmed for afrezza they can be complimentary. That will be the next big thing - programming the AP for use with afrezza. The AP operates off glucose levels so absorption is not a huge issue as the AP will adapt delivery to cope just as the pancreas does. You cannot use Afrezza in a closed loop device because it requires manual intervention and that means the device cannot support a closed loop (you have to take an action - it needs you to load the inhaler and inhale). I cannot see anyone doing the work for Afrezza in the DIY APS community because the whole focus is getting the AP to the same point of human involvement that a non-diabetic has with their pancreas. |
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Post by agedhippie on May 22, 2022 17:09:35 GMT -5
... The more I think about that $10M and how it should have been spent on a head to head trial with Mounjaro the more my head wants to explode. I sure hope Mike leverages what he has in the T1 SoC and does some great "Seeing is Believing" demos at ADA next week. He better do some demos on some T2s and non-diabetics taking afrezza and not getting hypos. The non-hypo demo is key for the Mounjaro trial. I would also suggest he leaves the V-Go at home and tries to figure out how to get out of the deal. I would be careful about the " Afrezza cannot cause hypos with T2" claim because both and earlier Mannkind trial as well as the Walnut Creek Dosing Optimization Study show Afrezza causing a hypo for a T2. |
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Post by prcgorman2 on May 22, 2022 17:33:29 GMT -5
Clearly, if you take enough insulin, you can cause a hypoglycemic event. What I would like to see is the safety of Afrezza as compared to other insulins specifically with regard to hypos.
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Post by anderson on May 23, 2022 3:13:33 GMT -5
Aged - this is where Al Mann was headed. He was looking for a faster insulin to put in his pumps. I think we are at about the limits of pumps and algorithms until there is a faster insulin and thats really hard because you have variables like insulin absorption. Afrezza on the other handle simplifies the mealtime spike and is very consistent. The pump can then do its thing. The AP and afrezza are not competitive devices. If the AP is used correctly and programmed for afrezza they can be complimentary. That will be the next big thing - programming the AP for use with afrezza. The AP operates off glucose levels so absorption is not a huge issue as the AP will adapt delivery to cope just as the pancreas does. You cannot use Afrezza in a closed loop device because it requires manual intervention and that means the device cannot support a closed loop (you have to take an action - it needs you to load the inhaler and inhale). I cannot see anyone doing the work for Afrezza in the DIY APS community because the whole focus is getting the AP to the same point of human involvement that a non-diabetic has with their pancreas. Already been done over a decade ago by the JDRF.
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Post by sayhey24 on May 23, 2022 6:06:15 GMT -5
... The more I think about that $10M and how it should have been spent on a head to head trial with Mounjaro the more my head wants to explode. I sure hope Mike leverages what he has in the T1 SoC and does some great "Seeing is Believing" demos at ADA next week. He better do some demos on some T2s and non-diabetics taking afrezza and not getting hypos. The non-hypo demo is key for the Mounjaro trial. I would also suggest he leaves the V-Go at home and tries to figure out how to get out of the deal. I would be careful about the " Afrezza cannot cause hypos with T2" claim because both and earlier Mannkind trial as well as the Walnut Creek Dosing Optimization Study show Afrezza causing a hypo for a T2. Come on Man! If I drink enough water I can drown myself too. The concern is is afrezza going to cause a dangerous situation for the T2. A BG going to 60 and then the liver kicking in and bringing it back happens with afrezza and happens with non diabetics. The concern is when taken in a reasonable manner does it cause a dangerous situation and if so what is the risk reward benefit when compared to a GLP1. In most cases you really have to try to get a severe hypo with afrezza when not on other meds, especially a basal. We saw in the Affinity2 trial no difference in hypos between antiglycemics and afrezza with the antiglycemics. Lets see what Mike does with demos next week. After seeing it maybe you too will become a believer. I am not expecting that to be the case but hope springs external. |
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Post by agedhippie on May 23, 2022 13:14:50 GMT -5
The AP operates off glucose levels so absorption is not a huge issue as the AP will adapt delivery to cope just as the pancreas does. You cannot use Afrezza in a closed loop device because it requires manual intervention and that means the device cannot support a closed loop (you have to take an action - it needs you to load the inhaler and inhale). I cannot see anyone doing the work for Afrezza in the DIY APS community because the whole focus is getting the AP to the same point of human involvement that a non-diabetic has with their pancreas. Already been done over a decade ago by the JDRF.
That, like the Yale experiment, is a hybrid closed loop like the Tandem or the 780G. The difference is that with closed loop system like the AAPS everything happens without user interaction. With a hybrid closed loop system you have to tell it you are eating and bolus for a rough number of carbs, and the system takes it from there cleaning up any mismatch. There cannot be true closed loop systems using Afrezza until someone figures out how to get it into your system without you doing anything. Hence, as I said, I cannot see the DIY APS community is not going to do the work for Afrezza - it runs counter to their mission to remove the human from the loop. |
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Post by agedhippie on May 23, 2022 13:21:38 GMT -5
I would be careful about the " Afrezza cannot cause hypos with T2" claim because both and earlier Mannkind trial as well as the Walnut Creek Dosing Optimization Study show Afrezza causing a hypo for a T2. Come on Man! If I drink enough water I can drown myself too. The concern is is afrezza going to cause a dangerous situation for the T2. A BG going to 60 and then the liver kicking in and bringing it back happens with afrezza and happens with non diabetics. The concern is when taken in a reasonable manner does it cause a dangerous situation and if so what is the risk reward benefit when compared to a GLP1. In most cases you really have to try to get a severe hypo with afrezza when not on other meds, especially a basal. We saw in the Affinity2 trial no difference in hypos between antiglycemics and afrezza with the antiglycemics. Lets see what Mike does with demos next week. After seeing it maybe you too will become a believer. I am not expecting that to be the case but hope springs external. I am happy to say that Afrezza is safer than RAA, however saying that it cannot cause hypos in T2 diabetics is a step to far for me. |
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Post by uvula on May 23, 2022 14:15:32 GMT -5
Aged one, technically you are correct of course. Completely closed loop means no user intervention. But you are hung up on the semantics.
If a small amount of user intervention yields better glucose control, isn't that better than a completely closed loop system? This is not rhetorical, I would like to know your opinion.
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Post by Deleted on May 23, 2022 15:39:08 GMT -5
Do Type 2 Patients on the V-GO use a CGM??
How would they know the amount of insulin to inject??
Also it looks like the V-GO only holds a 1 day supply (not sure on the capacity) so I'm assuming it's not a large vial in the V-GO. Anyone know the specifics?
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Post by cretin11 on May 23, 2022 15:51:08 GMT -5
It's to be expected. There is NO WAY the ADA or anyone is going to include Afrezza in the SOC. The BIG 3 will do everything in their power to squash it? Kendall probably thought he had enough clout to get it done. There is too much influence and power controlled by the BIG 3. The only way it will happen is after the PEDS Approval and MNKD's NEW PARTNER will initiate it. And that NEW PARTNER will have to be one of the BIG 3. The more I think about that $10M and how it should have been spent on a head to head trial with Mounjaro the more my head wants to explode. I sure hope Mike leverages what he has in the T1 SoC and does some great "Seeing is Believing" demos at ADA next week. He better do some demos on some T2s and non-diabetics taking afrezza and not getting hypos. The non-hypo demo is key for the Mounjaro trial. I would also suggest he leaves the V-Go at home and tries to figure out how to get out of the deal.Yes to your idea on returning V-Go. What's the return policy on these things, hmmm... I'd be good with an explanation like this: "We had this bell ringing ceremony scheduled but weren't sure if we'd get Tyvaso approval by then, and we needed something to celebrate. So we bought this super-niche insulin delivery system so as not to look foolish up there. But now that we got the approval (mere hours after the bell!), let's give back that lemon of a product. We don't need it, as Technosphere has been validated!" |
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Post by sportsrancho on May 23, 2022 16:36:06 GMT -5
Didn’t they know last time when we didn’t get approved, would stand to reason they knew this time:-)
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Post by agedhippie on May 23, 2022 16:53:17 GMT -5
Aged one, technically you are correct of course. Completely closed loop means no user intervention. But you are hung up on the semantics. If a small amount of user intervention yields better glucose control, isn't that better than a completely closed loop system? This is not rhetorical, I would like to know your opinion. No. The whole point of the artificial pancreas is that it is just that. This is why everything you see is both in the commercial market and in the DIY community is working towards zero user intervention - an artificial pancreas. |
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Post by Deleted on May 23, 2022 17:07:42 GMT -5
The more I think about that $10M and how it should have been spent on a head to head trial with Mounjaro the more my head wants to explode. I sure hope Mike leverages what he has in the T1 SoC and does some great "Seeing is Believing" demos at ADA next week. He better do some demos on some T2s and non-diabetics taking afrezza and not getting hypos. The non-hypo demo is key for the Mounjaro trial. I would also suggest he leaves the V-Go at home and tries to figure out how to get out of the deal.Yes to your idea on returning V-Go. What's the return policy on these things, hmmm... I'd be good with an explanation like this: "We had this bell ringing ceremony scheduled but weren't sure if we'd get Tyvaso approval by then, and we needed something to celebrate. So we bought this super-niche insulin delivery system so as not to look foolish up there. But now that we got the approval (mere hours after the bell!), let's give back that lemon of a product. We don't need it, as Technosphere has been validated!" Guys you're missing the point. MNKD bought V-GO to get access to the 10,000 customers. I would make a bet that V-GO goes BYE BYE in 18 months. MNKD will have a strategy to educate and convert the Type 2 Patient and the Doctor on Afrezza. In the meantime MNKD will get good Revenues from V-GO. WIN WIN |
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Post by sayhey24 on May 23, 2022 17:41:55 GMT -5
Yes to your idea on returning V-Go. What's the return policy on these things, hmmm... I'd be good with an explanation like this: "We had this bell ringing ceremony scheduled but weren't sure if we'd get Tyvaso approval by then, and we needed something to celebrate. So we bought this super-niche insulin delivery system so as not to look foolish up there. But now that we got the approval (mere hours after the bell!), let's give back that lemon of a product. We don't need it, as Technosphere has been validated!" Guys you're missing the point. MNKD bought V-GO to get access to the 10,000 customers. I would make a bet that V-GO goes BYE BYE in 18 months. MNKD will have a strategy to educate and convert the Type 2 Patient and the Doctor on Afrezza. In the meantime MNKD will get good Revenues from V-GO. WIN WIN OK - so please explain what getting access means. Are the sales reps going door to door like the Fuller Brush man to the PWDs and then what? Are they trying to convert them to afrezza without their doctor there? Are the sales reps going office to office to convince the doctors to prescribe afrezza and not V-Go? We have sent sales reps out like this before at least 2x and both times its been an epic fail. Then we laid off the sales reps. Why will it work now? Couldn't we just buy the prescribing doctor list for a lot less than $10M if that is the plan? If you could explain how this is going to work given the fact that they are currently losing money on each pump sold. Now the 8-k they filed today says we could be hiring up to 40 people. |
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Post by prcgorman2 on May 23, 2022 17:44:00 GMT -5
Buying a company to get their customers is a very common business strategy. How they're converted, how much is churn, is academic.
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