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Post by ktim on Jan 29, 2020 21:08:04 GMT -5
I think I had poor wording of my reply above given it was a question posed in the negative.
When I said "I would think that is the common assumption." I meant the common assumption is approval. I certainly assume approval will happen.
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Post by agedhippie on Jan 29, 2020 22:17:40 GMT -5
Kids are going to take to Afrezza like a duck to water. Especially when coupled with a CGM AND because Afrezza is much more forgiving than injected insulin when it comes to hypos. Word is spreading. Scrips are growing. Momentum is building.  . Anyone think there is a good chance the FDA will not approve it for kids? I expect it to get approved on the same label as for adults. At least we get to avoid the "is it safe in pumps?" trial. |
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Post by mnholdem on Jan 30, 2020 13:30:29 GMT -5
I've stated this before, but it's worth repeating. The Phase 3 trial must include data points that enable MannKind to filter out any non-compliance at the multiple trial sites. We've already heard of at least one Phase 2 trial participant who was dosed WAY too far ahead of the meal. This is an issue that greatly concerns me because many healthcare professionals are scared to death of insulin. There may be an inherent bias to play it safe by administering Afrezza the same as you would with injections. If that happens a lot, the trial results will be skewed to display unusually high levels of hypoglycemic events. Trial participants simply MUST NOT BE dosed too early because of Afrezza's rapid onset of action. At the very least, MannKind must have a way to filter out the data for any patients that were not dosed properly during the trials. The bottom line is that it is entirely plausable for Afrezza to miss it's primary endpoints of reducing A1c in the pediatric population. Even the risk of missing non-inferiority is possible. The reason is twofold: early dosing and under-dosing of pediatric patients. These issues are why I pray that the trial protocols have been designed with the FDA to make mandatory that trial sites record the exact number of minutes in which Afrezza was administered each participant before s/he eats their meals. We're dealing with two decades of bias regarding insulin, its dangers and perceptions about the correct ways to safely dose patients. Doctors and nurses are human and we're talking about administering insulin to children. I'm hopeful that Kendall has a handle on this and that his team will be monitoring for any problems. Since the FDA doesn't like the drug-maker getting too directly involved with trials sites, it's my sincere hope that the protocols have been designed in such a way as to quickly identify non-compliant dosing. Dr. Kendall has shown us before that he is paying attention to this detail when he presented study evidence that enable him to separate and to present remarkable results for patients that complied with Afrezza protocols.  |
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Post by mango on Jan 30, 2020 13:35:08 GMT -5
Can we request a copy of the exact Phase 3 protocol that is being used? Maybe under FOIA? Best to know instead of speculating.
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Post by rayskum on Jan 30, 2020 14:26:08 GMT -5
I've stated this before, but it's worth repeating. The Phase 3 trial must include data points that enable MannKind to filter out any non-compliance at the multiple trial sites. We've already heard of at least one Phase 2 trial participant who was dosed WAY too far ahead of the meal. This is an issue that greatly concerns me because many healthcare professionals are scared to death of insulin. There may be an inherent bias to play it safe by administering Afrezza the same as you would with injections. If that happens a lot, the trial results will be skewed to display unusually high levels of hypoglycemic events. Trial participants simply MUST NOT BE dosed too early because of Afrezza's rapid onset of action. At the very least, MannKind must have a way to filter out the data for any patients that were not dosed properly during the trials. The bottom line is that it is entirely plausable for Afrezza to miss it's primary endpoints of reducing A1c in the pediatric population. Even the risk of missing non-inferiority is possible. The reason is twofold: early dosing and under-dosing of pediatric patients. These issues are why I pray that the trial protocols have been designed with the FDA to make mandatory that trial sites record the exact number of minutes in which Afrezza was administered each participant before s/he eats their meals. We're dealing with two decades of bias regarding insulin, its dangers and perceptions about the correct ways to safely dose patients. Doctors and nurses are human and we're talking about administering insulin to children. I'm hopeful that Kendall has a handle on this and that his team will be monitoring for any problems. Since the FDA doesn't like the drug-maker getting too directly involved with trials sites, it's my sincere hope that the protocols have been designed in such a way as to quickly identify non-compliant dosing. Dr. Kendall has shown us before that he is paying attention to this detail when he presented study evidence that enable him to separate and to present remarkable results for patients that complied with Afrezza protocols. MN - completely agree. Someone in Facebook Afrezza group posted that some kids got hypos even after taking Afrezza at the beginning of meal because they tend to eat their meal at a much slower pace than adults. From that point of view, it makes more sense to puff sometime after the beginning of meal. |
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Post by chc on Jan 30, 2020 16:07:20 GMT -5
Because Afrezza Inhaled Insulin works so fast compared to injectable insulin my Wife takes Afrezza immediately after finishing the meal and we have counted the carbs. Some people leave a lot of food on their plate, especially young kids, and older people. So for them it is best to play it safe and take Afrezza after completing the meal. Taking Afrezza this way works out best for my Wife who is a type 2 taking a much reduced amount of Humalog Mix 75/25 and Afrezza. My Wife has been taking Afrezza this way for 4 years now with great A1C control and time in range.
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Post by mpg54 on Jan 30, 2020 16:22:48 GMT -5
. Anyone think there is a good chance the FDA will not approve it for kids? I would think that is the common assumption. Doesn't seem like there are any foreseeable reasons it would be denied... unless of course Trump pardons Shkreli and appoints him to run the FDA. Though it's still a pretty long time before they make that decision. I'd also question whether endos are going to jump on board with regard to children anymore than they have for adults. Though it certainly will help. I imagine even doctors that believe in Afrezza may take an approach with many of their adult T1s of "if it ain't broke don't fix it". They may be more proactive in suggesting Afrezza to newly diagnosed. Since most of those are children, ped approval would be important in that context. Parents will drive the growth for Kids. No parent wants jab their kid with a needle when Afrezza is available as an alternative. Endo’s will get run over ... |
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Post by ktim on Jan 30, 2020 20:09:11 GMT -5
Because Afrezza Inhaled Insulin works so fast compared to injectable insulin my Wife takes Afrezza immediately after finishing the meal and we have counted the carbs. Some people leave a lot of food on their plate, especially young kids, and older people. So for them it is best to play it safe and take Afrezza after completing the meal. Taking Afrezza this way works out best for my Wife who is a type 2 taking a much reduced amount of Humalog Mix 75/25 and Afrezza. My Wife has been taking Afrezza this way for 4 years now with great A1C control and time in range. Has she found that the Humalog Mix works better than basal + Afrezza? Is there some cost aspect to that decision? Might be worth documenting her dosing and results and forwarding that to MNKD. Anything that results in great A1c is worth them knowing about. |
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Post by ktim on Jan 30, 2020 20:24:41 GMT -5
I would think that is the common assumption. Doesn't seem like there are any foreseeable reasons it would be denied... unless of course Trump pardons Shkreli and appoints him to run the FDA. Though it's still a pretty long time before they make that decision. I'd also question whether endos are going to jump on board with regard to children anymore than they have for adults. Though it certainly will help. I imagine even doctors that believe in Afrezza may take an approach with many of their adult T1s of "if it ain't broke don't fix it". They may be more proactive in suggesting Afrezza to newly diagnosed. Since most of those are children, ped approval would be important in that context. Parents will drive the growth for Kids. No parent wants jab their kid with a needle when Afrezza is available as an alternative. Endo’s will get run over ... What percentage of parents do you think know about Afrezza? Rough guess is ok. And even for the parents that may learn of Afrezza, if there were one of the misguided endos that are still concerned about long term lung issues that told a parent inquiring about Afrezza "I really am not comfortable with prescribing it for pediatrics because there still hasn't been the long term lung safety trials and I'd be especially concerned about children whose lungs are still developing. I know little johnny probably isn't going to like the idea of an injection, but in reality kids get used to it. Out of a since of caution I really think we don't have enough info yet to take the risk with inhaled insulin." what do you think that parent is going to say? Are all these parents going to come prepared with the scores of studies MNKD has done showing why long term lung issues should not be a concern (many into the medical weeds and none specifically addressing children), or do you think most parents would trust the medical opinion of their doctor? If it's insurance road blocks, I'd fully agree a parent might go to battle even more so than they would for themselves. I just don't think most parents would try to battle their own physicians advice... maybe rare ones that really researched Afrezza to death. If, as some believe here, pediatrics will be a huge game changer, then I feel management has truly been negligent in dragging it out as long as they have. Are they negligent? Did they simply not believe it's game changer? |
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Post by letitride on Jan 30, 2020 21:23:51 GMT -5
The real question is what is little Johnny tell his parents when he reads about Afrezza on social media?
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Post by sportsrancho on Jan 30, 2020 21:39:50 GMT -5
When there’s kids at school using Afrezza and other kids see it and think it’s cool. That’s when it changes. Parents will research on their own and find a doctor who prescribes.
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Post by ktim on Jan 30, 2020 22:23:15 GMT -5
When there’s kids at school using Afrezza and other kids see it and think it’s cool. That’s when it changes. Parents will research on their own and find a doctor who prescribes. Has the prevalence of T1 gone up dramatically in the past few decades (real question, I don't know off hand)? In my entire experience k-12, I never remember seeing any kids taking insulin. In fact if there were kids with diabetes, which there must have been in big public schools, I didn't know who they were. I guess I'm not anticipating that many kids with diabetes are going to be showing off their medication in the same way that allowed vaping to sweep through our schools. Perhaps I'm just an old fogy and don't understand what kids find cool these days... "back in my day" we didn't talk about medications we were taking, I think most would have preferred blending in. I think you know/knew siblings that used it school age? Have they told you of classmates using it because of them? Already parents can find docs to prescribe off label to kids if they really have that level of conviction. Would be great if this plays out the way people hope it does. I'd jump for joy, but also be a bit upset with management for not recognizing it and moving a heck of a lot quicker. |
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Post by agedhippie on Jan 30, 2020 22:49:31 GMT -5
When there’s kids at school using Afrezza and other kids see it and think it’s cool. That’s when it changes. Parents will research on their own and find a doctor who prescribes. Has the prevalence of T1 gone up dramatically in the past few decades (real question, I don't know off hand)? In my entire experience k-12, I never remember seeing any kids taking insulin. In fact if there were kids with diabetes, which there must have been in big public schools, I didn't know who they were. I guess I'm not anticipating that many kids with diabetes are going to be showing off their medication in the same way that allowed vaping to sweep through our schools. Perhaps I'm just an old fogy and don't understand what kids find cool these days... "back in my day" we didn't talk about medications we were taking, I think most would have preferred blending in. ... It's not common. In the under 20 age group it's around 1 in 400 and that is weighted towards older end of that spectrum. Siblings can upset that ratio. |
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Post by sportsrancho on Jan 31, 2020 7:08:24 GMT -5
Tom’s son Jake shows his Dreamboat off to everyone because they all eat together. He’s in college now in Arizona. I know the family is friends with several other families that have T1 kids. People have gotten a hold of Tom from other states just because I’ve talked about it on Twitter.
You have to take Afrezza when you eat. So for grade school for instance, it’s not like the kid is sent to the nurse 20 minutes before lunch and then goes into the hall and no one knows.
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Post by slugworth008 on Jan 31, 2020 11:18:07 GMT -5
When there’s kids at school using Afrezza and other kids see it and think it’s cool. That’s when it changes. Parents will research on their own and find a doctor who prescribes. Absolutely !! and game on. Just need the pediatric results and FDA green light. That has to be right around the corner - at least I sure hope it is. |
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