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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 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 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 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 13:11:16 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.
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Post by agedhippie on May 2, 2024 9:34:56 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.
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Post by agedhippie on May 2, 2024 9:29:52 GMT -5
Why now is the easiest question I have had to answer for a long time. Because there was a decently sized clinical trial so they have data to speak about. There are a lot of things they do and try that the public never gets to hear about because there isn't clinical trial data to support it. Hmmm. Let me get this straight - all it took was the Inhale-3 study? For 20+ years these experts did not understand the 171, 118 and all the other studies and the NC results in the 171 yet here on proboards we could? Is that right? ... Yes. If you don't produce data then nobody has anything to talk about so don't be shocked when you are ignored. The trials you cite show that Afrezza gives worse outcomes than RAA for Type 1, and is better than nothing for Type 2. That was 10 years ago and since then it's been crickets, just occasional tiny studies. Getting publications is not rocket science, you just need data to present.
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Post by agedhippie on May 1, 2024 18:31:27 GMT -5
... We have ADA2024 happening next month. There seems to be some interesting movement in the industry toward afrezza. If you look at the Inhale-3 speaker lineup its an interesting list. Why after 10 years is this group coming forward and most likely going to say great things about afrezza? They have had 10 years. They are suppose to be experts. My guess is they are going to say nothing new to anyone who has been reading proboards. So why now? ... Why now is the easiest question I have had to answer for a long time. Because there was a decently sized clinical trial so they have data to speak about. There are a lot of things they do and try that the public never gets to hear about because there isn't clinical trial data to support it.
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Post by agedhippie on May 1, 2024 18:22:33 GMT -5
Why should Mike care to partner with Clofazimine (outside of an Asia Pacific region partner which is necessary)? Why should he partner for Nintedanib DPI (again, outside of any international partnership)? Why would you want Mike to give away huge percentages of revenue to partners from those two products when we have the capability to go solo and reap all, or majority, of the rewards? That’s how you move the needle. And before you or someone else mentions Afrezza as an example of why, let’s all remember that the SoC for NTM and IPF aren’t red taped like diabetes. There is very few effective treatments and they aren’t that great anyway, right? That’s why they’re in our pipeline. This is exactly what Mike said. The way to riches is not from licensing deals, it's from owning the drug and that is his strategy - identify and develop orphan drugs since by definition it's an under-served market.
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Post by agedhippie on May 1, 2024 7:52:18 GMT -5
Not been a lot of kool-aid or hopium peddled here lately. And, thankfully, a lot less foo as well. Almost boring. I generally like it, although sayhey24 eliciting informative responses from agedhippie is always a welcome break from the quiet. Speaking of which, is there a debate here on the pipeline candidates we're missing? Surely there's something controversial about clofazimine and nintedanib. The thing about orphan drugs is that they are almost anything is better than the alternative regardless of efficiency or side effects. I would expect clofazimine to work since it already works as an oral med, the question there is if inhaling it will improve the action which logically would seem likely. Likewise nintedanib was approved in 2014 so there is no reason it shouldn't work as an inhaled med that I can see. The only obstacle I can see is insurance. That shouldn't be a problem for clofazimine since there isn't a real option and it may be classed as a hospital benefit anyway. There is already an oral version of nintedanib so the outcome in that case matters far more or the insurers will just stick with the oral med (I am assuming the inhaled version will be more expensive.)
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Post by agedhippie on Apr 27, 2024 10:12:01 GMT -5
It's a trial, she will use whatever the protocol calls for. Beyond that I have no idea but I wouldn't tell a random endo in a team what to use - my own endo is a different matter This is also a good example why you should use firms like Jaeb. They have a great deal of credibility in the diabetes arena so collaborators will work with them when they may well not be otherwise interested. Why not? I wouldn't think twice about talking about afrezza to anyone, especially a supposed "expert". Sometimes I learn something, sometimes they do. Then again I am a true believer. In this case she must see something in afrezza unless she just needed a payday which I hope is not the case. ... Yeah. That's not how these places work. In summary - Yes, as a long time endo, and the head of Type 1 research at Mt Sinai she is an expert and not a supposed "expert". - Endos in that hospital system don't talk to sales reps, and definitely not random strangers wanting to tell them about "paradigm shifts"! - They have prescribed Afrezza in the past - Clinical trials like this are definitely not a money maker. As I have said in the past I donate to Mt Sinai so I get some sight of the research they are doing occasionally. Trials like this one are the sort of thing they do, but it needs to be credible which is where Jaeb comes in, it needs to be a multi-center trial (anything else is probably to small), and it needs to fit the research teams interest which I suspect in this case is if Afrezza is a viable option to an AID pump in pregnancy. The money they receive for this trial is unlikely to even cover their costs.
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Post by agedhippie on Apr 26, 2024 15:47:09 GMT -5
I apologize in advance for the formatting. Carol Levy is interesting. She is part of the diabetes clinic I use and will be interest to see what she has to say. This is particularly interesting because she works with women who are pregnant and need to tightly control their levels. ... How did she get involved with afrezza? Did you suggest it? It's a trial, she will use whatever the protocol calls for. Beyond that I have no idea but I wouldn't tell a random endo in a team what to use - my own endo is a different matter This is also a good example why you should use firms like Jaeb. They have a great deal of credibility in the diabetes arena so collaborators will work with them when they may well not be otherwise interested.
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Post by agedhippie on Apr 26, 2024 13:03:27 GMT -5
I apologize in advance for the formatting. Carol Levy is interesting. She is part of the diabetes clinic I use and will be interest to see what she has to say. This is particularly interesting because she works with women who are pregnant and need to tightly control their levels.
----- Symposium - The Efficacy and Safety of Inhaled Insulin Used with Insulin Degludec Compared with Automated Insulin Delivery or Mulitple Daily Insulin Injections in Adults with Type 1 Diabetes—Results of the INHALE-3 Randomized Trial (Includes Livestream)
Sat, Jun 22 W320 (Chapin Theater)
8:00am - 9:30am (Eastern)
Symposium - Chair Roy W Beck
Presentation Symposium - Inhaled Insulin’s History and Study Rationale 8:00am-8:10am Jun 22 (Eastern) Halis K Akturk
Presentation Symposium - Study Methods and Participant Baseline Characteristics 8:10am-8:20am Jun 22 (Eastern) Yogish C Kudva
Presentation Symposium - Study Results I—Comparison of Inhaled Insulin vs. Rapid-Acting Analogue Insulin in Users of Automated Insulin Delivery or Multiple Daily Insulin Injections during Standardized In-Clinic Meal Challenges 8:20am-8:30am Jun 22 (Eastern) Ruth S Weinstock
Presentation Symposium - Study Results II—Primary Efficacy, Safety, and Quality of Life Outcomes 8:30am-8:40am Jun 22 (Eastern) Carol J Levy
Presentation Symposium - Study Results III—Effect of Inhaled Insulin-Degludec Compared with Automated Insulin Delivery and in Subgroups According to Participant Characteristics 8:40am-8:50am Jun 22 (Eastern) Grazia Aleppo
Presentation Symposium - Critique of Study Design and Results 8:50am-9:00am Jun 22 (Eastern) Irl B Hirsch
Presentation Symposium - Use of Inhaled Insulin in Clinical Practice 9:00am-9:10am Jun 22 (Eastern) Thomas Blevins
Presentation Symposium - Question and Discussion Period 9:10am-9:30am Jun 22 (Eastern)
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Post by agedhippie on Apr 19, 2024 22:12:11 GMT -5
It will be interesting to see if VDex can help her. Lets see what they say. Lets see if she is actually using the Levimar has the hammer and with afrezza and a smaller dose of Tresiba she can actually address the issue better. I am pretty sure Ginger Vieira discusses this in one of her articles. As a T1 you cannot do that because you will have insufficient insulin at night which will be problematic. You will also have to take Afrezza every two hours while you are awake. What Ginger may have been talking about is that people tend not to do basal testing regularly and end up using their basal to partially cover meals and taking less RAA. That's generally a bad idea. Ginger was probably saying take the right amount of basal and bolus instead which often ends up being less basal and more bolus. Commonly people run into this when they switch from MDI to pump because endos make you basal test to get the numbers on the pump right.
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Post by agedhippie on Apr 19, 2024 10:53:17 GMT -5
Afrezza is a meal time insulin, Levemir is a basal insulin. You cannot replace Levemir with Afrezza as they have different roles. You got me thinking about basal versus bolus last night. I started to do some research but it was painful to find what I was looking for. What I wanted to know is if the pancreas essentially leaks insulin (basal) and somewhere it stores some of the leaking basal for a mealtime bolus. Is there an insulin bladder in the pancreas? Or are there some beta cells that hold on to their insulin and then release on demand? I assume all insulin is created equally and it is a simple matter of “background” versus bolus. I am absolutely certain that is too much of an oversimplification, but wondered if it was a directionally correct understanding (or perhaps just hopelessly wrong). You pretty much have it correct. Insulin is held in vesicles which are small sacks so not unlike lots of tiny bladders. These are attached to the plasma membrane when they are needed and the membrane is de-polarized. Thi is largely of academic interest to me as a T1 since my immune system ate the lot! The full mechanism is still not entirely understood because there are so many moving parts. Your body steadily consumes glucose even is a resting state. To provide that energy it releases a steady stream of glucose which provokes the pancreas to release a matching stream of insulin. That is your basal glucose supply. That glucose release isn't constant, it's highest just before dawn, and lowest around 2am at night. Injectable basal insulin is a trade off between those two points which is why night time hypos happen (if you inject at about 7pm then all of that insulin should be out of your system by midnight although that varies from person to person.) There isn't a big margin for error as a T1 on overnight insulin. When you eat your glucose level rises and more vesicles get coupled to the plasma membrane and release their insulin. This is the result of the electrolytic change produced by that rise.
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