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Post by daisyz on Apr 17, 2024 20:36:36 GMT -5
So what you're saying sayhey24 is that this would be even cheaper than we think? What would be cheaper - getting the refrigeration issue updated on the label? Assuming they still have all the info they have to go through the FDA process. The FDA is a process and will probably cost a couple $M. Mike has already said after the kids trial they are going for label changes. Hopefully this is in there - in a couple of years. If you read some of the social media stuff people leave it in their hot cars for weeks and say they have no issue with it, which makes sense. I know some people want to say "all insulin" and lump afrezza in with all the other insulin but its not. This will take some lobbying with the FDA and BP is going to push back on it. I hope when they go for changes they also get rid of the 4u/8u/12u and replace it with small, medium and large. Existing T1s converting won't like it but for everyone else including the T1 kids it would make so much sense. Why not change the cartridge labels to 2, 4 and 6 units. Diabetics are used to dealing in units. ...or, add a bit more powder and change to 3, 6, 9. More studies, I realize.
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Post by porkini on Apr 17, 2024 20:50:47 GMT -5
What would be cheaper - getting the refrigeration issue updated on the label? Assuming they still have all the info they have to go through the FDA process. The FDA is a process and will probably cost a couple $M. Mike has already said after the kids trial they are going for label changes. Hopefully this is in there - in a couple of years. If you read some of the social media stuff people leave it in their hot cars for weeks and say they have no issue with it, which makes sense. I know some people want to say "all insulin" and lump afrezza in with all the other insulin but its not. This will take some lobbying with the FDA and BP is going to push back on it. I hope when they go for changes they also get rid of the 4u/8u/12u and replace it with small, medium and large. Existing T1s converting won't like it but for everyone else including the T1 kids it would make so much sense. Why not change the cartridge labels to 2, 4 and 6 units. Diabetics are used to dealing in units. ...or, add a bit more powder and change to 3, 6, 9. More studies, I realize. Those already are in units, just not comparable units to injectibles.
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Post by agedhippie on Apr 17, 2024 22:14:01 GMT -5
Why not change the cartridge labels to 2, 4 and 6 units. Diabetics are used to dealing in units. ...or, add a bit more powder and change to 3, 6, 9. More studies, I realize. Those already are in units, just not comparable units to injectibles. It was meant to be a 1:1 conversion but they didn't get it right. It should be a really easy fix though - just a glycemic clamp showing the conversion factor is off. I would have been surprised if it took more than a month to perform + an indeterminate delay for the FDA to revise the label.
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Post by sayhey24 on Apr 18, 2024 8:03:41 GMT -5
What would be cheaper - getting the refrigeration issue updated on the label? Assuming they still have all the info they have to go through the FDA process. The FDA is a process and will probably cost a couple $M. Mike has already said after the kids trial they are going for label changes. Hopefully this is in there - in a couple of years. If you read some of the social media stuff people leave it in their hot cars for weeks and say they have no issue with it, which makes sense. I know some people want to say "all insulin" and lump afrezza in with all the other insulin but its not. This will take some lobbying with the FDA and BP is going to push back on it. I hope when they go for changes they also get rid of the 4u/8u/12u and replace it with small, medium and large. Existing T1s converting won't like it but for everyone else including the T1 kids it would make so much sense. Why not change the cartridge labels to 2, 4 and 6 units. Diabetics are used to dealing in units. ...or, add a bit more powder and change to 3, 6, 9. More studies, I realize. The 4, 8 and 12 refer to the amount of insulin you should get assuming 60% of the powder in the cartridge is lost in the mouth, throat, etc. The cartridges contain 10, 20 and 30 units. Al Mann thought by calling them units he was overcoming one of the biggest issues with Exubera which was dosing. He thought this would make it easy. It ended up being one of MNKD biggest marketing mistakes. The first problem associating afrezza with "units" pigeon holes it into the "insulin space". Afrezza is much bigger and different than any previous insulin or diabetic treatment. From a marketing perspective the word "insulin" should be hidden as much as possible. "Insulin" is always associated in a bad way. The second problem is existing subq users need to be very precise in taking there insulin and they assume the same is true for afrezza. It is not but they try and calculate and under dose in fear of going low. Then they complain its not working. The most important reason is dosing afrezza is really easy when you stop trying to compare it to subq. The basic rule is "go big" on the dose. For T2s not on subq they are not getting a severe low and for T1s its still kind of hard since afrezza is out so fast. If you have a snack take a small. If you have a big carb meal take a large and then probably follow up dose. Its easy but its been made with the label very complicated.
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Post by agedhippie on Apr 18, 2024 8:49:01 GMT -5
... The most important reason is dosing afrezza is really easy when you stop trying to compare it to subq. The basic rule is "go big" on the dose. For T2s not on subq they are not getting a severe low and for T1s its still kind of hard since afrezza is out so fast. If you have a snack take a small. If you have a big carb meal take a large and then probably follow up dose. Its easy but its been made with the label very complicated. I would caution how large you go on the dose as a T1. MNKD did a trial on variable carb meals for a fixed dose ( classic.clinicaltrials.gov/ct2/show/results/NCT00747006) and halted the T1 arm after everyone got hypos when they ate 50% of the meal. That is not to say eating 75% of the meal would cause a hypo for a T1, but rather to be careful and see what works for you personally. The T1 world has far less insulin resistance than the T2 world so there isn't the same margin for safety. From the trial: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI.
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Post by prcgorman2 on Apr 18, 2024 8:49:51 GMT -5
I wouldn't change anything about the cartridge sizes (because that's a serious amount of stuff to have to do), but I like the idea of changing the labeling associated with them. I assume the chosen unit numbers were intentionally conservative (on the high side) for safety's sake. I think a label change using smaller unit numbers as daisyz suggested is probably the smartest thing to do for the very reason daisyz explained, There would need to be some education to let existing users know the units of Afrezza were labeled smaller in order to more closely approximate units of RAA. Approximating RAA units is a squishy thing though. If you reduce the units on the labeling so that more Afrezza is used, I assume that SHOULD work better for the person with diabetes and reduce how frequently stacking is required, but Afrezza is ultra-rapid and that really needs to be emphasized on the label too to ensure patients actively expect to see blood glucose levels more rapidly diminish, but also to see blood glucose more rapidly rise, especially after a big meal or lots of carbs and the bolus of Afrezza human insulin clears the system. I hope I never become expert at managing my diabetes using Afrezza (because I hope I never become a T2), but for sure this board (esp., folks like agedhippie and others) and also Afrezza users on diabetes social media, have taught me using Afrezza is NOT like using RAA regardless of what you do with size names (units or S, M, & L) and so changing the units on the label could help with better bolus dosing but the ultra-rapid aspect has to be a key part of user education.
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Post by prcgorman2 on Apr 18, 2024 8:51:49 GMT -5
... The most important reason is dosing afrezza is really easy when you stop trying to compare it to subq. The basic rule is "go big" on the dose. For T2s not on subq they are not getting a severe low and for T1s its still kind of hard since afrezza is out so fast. If you have a snack take a small. If you have a big carb meal take a large and then probably follow up dose. Its easy but its been made with the label very complicated. I would caution how large you go on the dose as a T1. MNKD did a trial on variable carb meals for a fixed dose ( classic.clinicaltrials.gov/ct2/show/results/NCT00747006) and halted the T1 arm after everyone got hypos when they ate 50% of the meal. That is not to say eating 75% of the meal would cause a hypo for a T1, but rather to be careful and see what works for you personally. The T1 world has far less insulin resistance than the T2 world so there isn't the same margin for safety. From the trial: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI.Excellent point. Should that difference between T1 use and T2 use be emphasized on the label too?
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Post by agedhippie on Apr 18, 2024 8:59:13 GMT -5
I would caution how large you go on the dose as a T1. MNKD did a trial on variable carb meals for a fixed dose ( classic.clinicaltrials.gov/ct2/show/results/NCT00747006) and halted the T1 arm after everyone got hypos when they ate 50% of the meal. That is not to say eating 75% of the meal would cause a hypo for a T1, but rather to be careful and see what works for you personally. The T1 world has far less insulin resistance than the T2 world so there isn't the same margin for safety. From the trial: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI.Excellent point. Should that difference between T1 use and T2 use be emphasized on the label too? I haven't seen that done before, but it's not a bad idea at all. I am not quite sure how they would do it but maybe expand the Indications and Usage section to point to differing dosing in the Dosage and Administration section?
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Post by sayhey24 on Apr 18, 2024 9:07:01 GMT -5
Excellent point. Should that difference between T1 use and T2 use be emphasized on the label too? I haven't seen that done before, but it's not a bad idea at all. I am not quite sure how they would do it but maybe expand the Indications and Usage section to point to differing dosing in the Dosage and Administration section? I have always thought there should be 2 separate products with different packaging - one for T1s and one for T2s.
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Post by mango on Apr 18, 2024 10:48:51 GMT -5
From mango: "I imagine Mike has/is doing all he can. Health insurance is a corrupt man’s game. I really like what Mark Cuban has done with his online pharmacy store. He is 100% transparent with the drug pricing, and they mark up the cost 15% for profit, and they list the wholesale cost of each drug. They don’t have a lot available yet, but would be awesome if Mike could get Afrezza on there at an affordable price to bypass the insurance companies." Doesn't this only work if Cuban is selling generic drugs? In our case, the high price is from mnkd because it costs a lot to make. No. It does not cost a lot to make. One of the biggest costs is filling and packaging. Cuban was at one time really big on bringing $35 insulin to market - prior to the Inflation Reduction Act $35 insulin. I explained to him back then you can already get $25 insulin at Walmart and that not all insulins are the same. It seemed odd to me but the guy who started Costplusdrugs is a diabetic and should have explained this to him. Anyway Mark got really interested in afrezza once he understood why it was so different. Afrezza was priced the way it is because Al Mann thought it was so great the market will pay this and premium priced it. Could afrezza pricing be reduced, absolutely. Could it fit Cuban's model, IDK as it was never negotiated. If Cuban had it, could he make afrezza a household name? IDK but I do know I would like to give it a try since Tyvaso DPI is paying the bills. When/where did Mike say he turned down putting Afrezza on Mark Cuban’s online pharmacy? Also, how do you know Mark Cuban is/was interested in Afrezza? He was on the Lex Fridman podcast recently and never mentioned Afrezza unfortunately.
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Post by ktim on Apr 18, 2024 12:36:10 GMT -5
I have come to think it is great we have Tyvaso DPI and a pipeline that now makes the fixing of Afrezza non essential... not withstanding that everyone here would have made it a blockbuster if only.
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Post by ktim on Apr 19, 2024 14:49:40 GMT -5
Nice move in MNKD on a down day.
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Post by BD on Apr 22, 2024 10:26:34 GMT -5
OK, I've unlocked the thread but please, if you want to continue the discussion of insulin and diabetes physiology, do it in the new thread I created for it in the Diabetes forum.
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Post by runner on Apr 22, 2024 15:09:17 GMT -5
In the green until exactly an hour before the market close. It’s almost as if somebody programs an algorithm to drive this stock down at prearranged times. So frustrating.
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Post by cretin11 on Apr 22, 2024 15:28:32 GMT -5
In the green until exactly an hour before the market close. It’s almost as if somebody programs an algorithm to drive this stock down at prearranged times. So frustrating. Frustrating it indeed is. One can only celebrate $4.20 so much before it starts getting old and you build up a tolerance...
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