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Post by sayhey24 on May 2, 2024 15:25:14 GMT -5
Pediatric trial questions: 1. Are participants under the care of both the study medical team and their own doctor/endo or just the study team? 2. How many in the trial are in the 16-18 age group that will be taking trial results to a new endo in the next couple of years? 3. Assuming favorable trial results, would a pediatric endo help refer and pass along trial info to an adult endo? Subjects ≥4 and <18 years of age - we won't know until after the results are analyzed how many were 16 and 17. classic.clinicaltrials.gov/ct2/show/NCT04974528 |
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Post by sayhey24 on May 2, 2024 15:39:24 GMT -5
There is one thing that seems to get overlooked. In Type 1 pediatrics and adults have separate endos, they do not cross over. You switch endos from a pediatric endo to and adult endo when you are about 18 years old. The pediatrics trial will interest the pediatrics endos, but be far less important to the adult endos. I probably wasn't very clear there. When they switch to the adult endo there will be a review of the existing treatment, but if Afrezza is working for them the endo is very unlikely to change it. My comment was more along the lines of not expecting the pediatric trial results to have a lot of impact with endos treating adults since there seemed to be an idea that the pediatrics trial could change the adult SoC. Aged - most adult T1s are not going to change. However with the great pediatric results these "experts" need to get out in front of the news so they don't look bad so they can say they told us how great afrezza is. At the same time it costs too damn much and getting insurance coverage is a trip to hell. As far as an adult SoC, do you think they are going to update section 14 and not update section 9??? Afrezza was only approved for adults because it was at the time "too risky" for the kids. Now we have the Inhale-1, Inhale-2 and Inhale-3 and a bunch of experts saying how great it is and you are saying we will have no updates to section 9? Lets say afrezza becomes SoC in section 14, what do insurance companies do, only cover the kids? |
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Post by agedhippie on May 2, 2024 16:11:27 GMT -5
Aged - most adult T1s are not going to change. However with the great pediatric results these "experts" need to get out in front of the news so they don't look bad so they can say they told us how great afrezza is. At the same time it costs too damn much and getting insurance coverage is a trip to hell. As far as an adult SoC, do you think they are going to update section 14 and not update section 9??? Afrezza was only approved for adults because it was at the time "too risky" for the kids. Now we have the Inhale-1, Inhale-2 and Inhale-3 and a bunch of experts saying how great it is and you are saying we will have no updates to section 9? Lets say afrezza becomes SoC in section 14, what do insurance companies do, only cover the kids? Pediatric data does not into adult data. Adult endos will wait for data from adult trials. Do the work or don't be surprised when you are ignored. I would expect Section 14 (Children and Adolescents) to be bought into line with Section 9 (Pharmacologic Therapy for Adults With Type 1 Diabetes). I seriously doubt they will go beyond that on a single trial, certainly there is zero chance that it becomes the SoC for kids simply because that is not how the SoC works. That will leave kids in the same place as adults for insurance cover |
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Post by agedhippie on May 2, 2024 16:17:45 GMT -5
Pediatric trial questions: 1. Are participants under the care of both the study medical team and their own doctor/endo or just the study team? 2. How many in the trial are in the 16-18 age group that will be taking trial results to a new endo in the next couple of years? 3. Assuming favorable trial results, would a pediatric endo help refer and pass along trial info to an adult endo? The reason there are separate pediatric and adult endos is because these two groups behave differently metabolically. It means the results from one are not valid for the other. That said; if the person is on Afrezza and has decent control then the adult endo is very unlikely to move them off Afrezza. Their insurance cover shouldn't change unless they swap insurers. |
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Post by sayhey24 on May 2, 2024 16:51:56 GMT -5
Aged - most adult T1s are not going to change. However with the great pediatric results these "experts" need to get out in front of the news so they don't look bad so they can say they told us how great afrezza is. At the same time it costs too damn much and getting insurance coverage is a trip to hell. As far as an adult SoC, do you think they are going to update section 14 and not update section 9??? Afrezza was only approved for adults because it was at the time "too risky" for the kids. Now we have the Inhale-1, Inhale-2 and Inhale-3 and a bunch of experts saying how great it is and you are saying we will have no updates to section 9? Lets say afrezza becomes SoC in section 14, what do insurance companies do, only cover the kids? Pediatric data does not into adult data. Adult endos will wait for data from adult trials. Do the work or don't be surprised when you are ignored. I would expect Section 14 (Children and Adolescents) to be bought into line with Section 9 (Pharmacologic Therapy for Adults With Type 1 Diabetes). I seriously doubt they will go beyond that on a single trial, certainly there is zero chance that it becomes the SoC for kids simply because that is not how the SoC works. That will leave kids in the same place as adults for insurance cover Inhale-3 doesn't count now? How many kids were in that? We better get some changes to the SoC with Inhale-1, Inhale-2 and Inhale-3 but BP will be doing everything they can do to block it. At the same time we have this group of experts who seem to be getting nervous word on how good afrezza is going to get out and they need to get ahead of it. Lets listen to the experts and see how much they learned from Proboards. |
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Post by ktim on May 2, 2024 18:19:26 GMT -5
Pediatric data does not into adult data. Adult endos will wait for data from adult trials. Do the work or don't be surprised when you are ignored. I would expect Section 14 (Children and Adolescents) to be bought into line with Section 9 (Pharmacologic Therapy for Adults With Type 1 Diabetes). I seriously doubt they will go beyond that on a single trial, certainly there is zero chance that it becomes the SoC for kids simply because that is not how the SoC works. That will leave kids in the same place as adults for insurance cover Inhale-3 doesn't count now? How many kids were in that? We better get some changes to the SoC with Inhale-1, Inhale-2 and Inhale-3 but BP will be doing everything they can do to block it. At the same time we have this group of experts who seem to be getting nervous word on how good afrezza is going to get out and they need to get ahead of it. Lets listen to the experts and see how much they learned from Proboards. I wish I had your talent for always knowing what others are thinking  |
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Post by sayhey24 on May 2, 2024 19:09:39 GMT -5
Inhale-3 doesn't count now? How many kids were in that? We better get some changes to the SoC with Inhale-1, Inhale-2 and Inhale-3 but BP will be doing everything they can do to block it. At the same time we have this group of experts who seem to be getting nervous word on how good afrezza is going to get out and they need to get ahead of it. Lets listen to the experts and see how much they learned from Proboards. I wish I had your talent for always knowing what others are thinking Its not talent. Its experience. When you get as old as me you will understand. Some advice I will give you - always follow the money. Tell me why these experts have been in hiding for over 10 years? Why? Did we really learn anything with Inhale-3, no. Nothing beats afrezza for TTIR after meals. There was a reason Al Mann put $1B of his own money into this. With Inhale-1 we probably learned that the kids did not need the XSM (2U) cartridge as much as some thought. Aside from that probably not much. Are we to believe these "experts" had to wait for Inhale-3 to understand how great afrezza is? |
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Post by agedhippie on May 2, 2024 19:10:54 GMT -5
Inhale-3 doesn't count now? How many kids were in that? We better get some changes to the SoC with Inhale-1, Inhale-2 and Inhale-3 but BP will be doing everything they can do to block it. At the same time we have this group of experts who seem to be getting nervous word on how good afrezza is going to get out and they need to get ahead of it. Lets listen to the experts and see how much they learned from Proboards. I wish I had your talent for always knowing what others are thinking He has his little fantasies, I try not to disturb them  |
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Post by agedhippie on May 2, 2024 19:25:58 GMT -5
Inhale-3 doesn't count now? How many kids were in that? ... How many kids? None. Read the title of the trial and you will understand why. |
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Post by sayhey24 on May 3, 2024 6:38:52 GMT -5
Inhale-3 doesn't count now? How many kids were in that? ... How many kids? None. Read the title of the trial and you will understand why. I can't keep up with you. For the longest time you said the 175 even though it showed superiority was not a good study because it used the placebo as the adder. Then you finally admitted it was a good study since thats the way the SoC works. Now you say we will get no movement on the SoC because we have not done enough studies. You say Inhale-1 for the kids is not enough, we need more. The Inhale-3 is not enough, I am not sure why. You said it was not for adults but it clearly is. The Inhale-2 did something and was a good size trial for the T2s and Mike said he expected a 1.5 - 2% A1C reduction. Here is what I know. When I read most of these studies they usually say at the end we need more studies. Thats the study industry. You always need more. You always need to send more money to the study industry for another study so they can pay their electric bill. BP does this and keeps them in their pocket. IMO we have done enough studies on human insulin. We now have the 1927 Yankee's ready to present on Inhale-3 at ADA2024. Nothing with afrezza has changed in 20 years except the inhaler and the label dosing. There are a zillion studies on insulin and there are plenty back in the file cabinet on afrezza. In fact Dave Kendall found them. I would think someone besides Dave could read them. If Mike can't get some movement in both section 9 and 14 of the SoC this time around Mike needs to go and I need to go. |
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Post by prcgorman2 on May 3, 2024 7:23:33 GMT -5
Hmmm, Mike doesn’t design the trials. That’s a collaborative effort including the FDA in some cases which I assume includes INHALE 1 because there’s been open aspiration to appeal to the FDA for approval of prescription to children. The CEO doesn’t execute the trials, publish, or interpret the results. The SoC may not change. I do not assume that it will change for some of the reasons you elaborate including and especially pressure from big industry players on an industry association. I assume that is real and not a joke. I would be sad to see you give up after all this, especially in the face of success despite Afrezza. MannKind is no longer a one trick pony. I’ve not given up on Afrezza but at this point I feel like its along for the ride and if it can somehow manage to pay for its own trials and promotion, perfect. Hope springs eternal.
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Post by sportsrancho on May 3, 2024 8:00:28 GMT -5
"Inhaled insulin is now considered “standard of care” for diabetics, according to updated guidelines from the American Diabetes Association." www.youtube.com/watch?v=POiyZVwjabQ |
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Post by agedhippie on May 3, 2024 8:36:57 GMT -5
How many kids? None. Read the title of the trial and you will understand why. I can't keep up with you. For the longest time you said the 175 even though it showed superiority was not a good study because it used the placebo as the adder. Then you finally admitted it was a good study since thats the way the SoC works. Now you say we will get no movement on the SoC because we have not done enough studies. You say Inhale-1 for the kids is not enough, we need more. The Inhale-3 is not enough, I am not sure why. You said it was not for adults but it clearly is. The Inhale-2 did something and was a good size trial for the T2s and Mike said he expected a 1.5 - 2% A1C reduction. ... Read what I say, not what you think I said. Once more and slowly. The 175 trial, aka. INHALE-2, establishes is that for a broad population (good) it is better to take Afrezza than not to take anything (meh). What to you want, a slogan like "Afrezza, better than not taking anything"? This is patently trolling - The Inhale-3 is not enough, I am not sure why. You said it was not for adults but it clearly is. Look at my response to your question about how many kids there are in INHALE-3, it's easy, it's quoted in your reply (and the first quote in this reply.) |
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Post by prcgorman2 on May 3, 2024 8:44:18 GMT -5
I don't think he was trolling (necessarily), but simply got mixed up.
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Post by agedhippie on May 3, 2024 9:00:58 GMT -5
I don't think he was trolling (necessarily), but simply got mixed up. It happens a lot. |
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