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Post by mannmade on Dec 21, 2019 13:12:53 GMT -5
Yes as I recall in the trials Afrezza was dosed the same as RAA’s meaning 30 mins or so before the meal which means it was almost out of the system by the time one ate.
Matt once told me they had in hindsight put themselves at a disadvantage and it was lucky they got they received a non inferior label.
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Post by rockstarrick on Dec 21, 2019 16:55:01 GMT -5
Yes as I recall in the trials Afrezza was dosed the same as RAA’s meaning 30 mins or so before the meal which means it was almost out of the system by the time one ate. Matt once told me they had in hindsight put themselves at a disadvantage and it was lucky they got they received a non inferior label. Not only in the trials!! after Afrezza was launched by Sanofi the label was telling them to take it too early. A guy I worked with would take it 10 to 20 minutes before he would eat, then was afraid to take the follow up dose. I tried to tell him he was taking it too soon, and that he could just take more if he was still out of range, but he said it doesn’t work that way. They, (Sanofi), were just turning patients loose with no direction whatsoever. Because of the label instructing him wrong, the dreamboat caking up, and the cough, we lost him as a patient. Hard to Imagine a Company smart enough to get Afrezza approved would allow it to be handled so carelessly. MNKD, SNY, and the FDA are all to blame, what a shame. And now that people are figuring out how to really use Afrezza, it’s even more apparent how bad they screwed up. I just wonder how long it will take for the Healthcare System to finally realize how wrong they are to make it so hard to just get a prescription that’s covered by insurance. Eventually they’re all going to look either extremely crooked or dumb. 😎 |
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Post by sportsrancho on Dec 21, 2019 17:30:15 GMT -5
And then with the kids in the trials they gave them Afrezza and then took them on a walk before they went to lunch. 20 min to early.
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Post by brianrocco on Dec 21, 2019 17:46:33 GMT -5
A stupid question from a non-diabetic: Although this study showed almost a 50% reduction in hypoglycemic events using Afrezza as opposed to asparte insulin , there remained a worrying incidence of hypoglycemic events -- more than 1 per participant -week on average. Does a more recent study using strategies of multi-dosing during meals in conjunction with a CGM show significant further reduction in incidence of hypoglycemic events? Many thanks. The STAT study is probably what you are after - www.liebertpub.com/doi/10.1089/dia.2018.0200At the end of the day Afrezza is still insulin, and getting the dose or timing wrong can still get you a hypo even if the margin for error is greater on the dosing. Thanks agedhippie from an agedbrianrocco. My non-technical understanding is that the STAT study of September 2018 shows the incidence of relatively serious hypoglycemic events being reduced by 75% (versus 50% in the earlier study) when Afrezza and CGMs were used according to directions versus those using aspart. Also, time in range was higher for those using Afrezza. The authors further suggested that results of using Afrezza might be have been further improved if the participants had been more experienced using Afrezza. For example, it appeared that study participants underdosed for evening meals, not evidencing confidence in the shorter duration of Afrezza. It's interesting that studies probably require the randomization of participants, thus eliminating the advantages of individuals learning how to better use Afrezza over time. |
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Post by mnholdem on Dec 21, 2019 20:26:24 GMT -5
And then with the kids in the trials they gave them Afrezza and then took them on a walk before they went to lunch. 20 min to early. Yes. That event happened to be reported early during the current pediatric trial. In fact, it may be happening more frequently than desired, so it's critical that Dr. Kendall makes certain that the timing of each dose is one of the data points recorded during the Phase 3 trial. It can be extremely difficult to convince endocrinologists, when they've become so accustomed to dosing RAA insulin 15-20 minutes pre-meal for decades. If MannKind screws up the Phase 3 trial cohorts, it will likely be devastating to the company. |
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Post by lifebreath on Dec 21, 2019 21:24:19 GMT -5
And then with the kids in the trials they gave them Afrezza and then took them on a walk before they went to lunch. 20 min to early. Yes. That event happened to be reported early during the current pediatric trial. In fact, it may be happening more frequently than desired, so it's critical that Dr. Kendall makes certain that the timing of each dose is one of the data points recorded during the Phase 3 trial. It can be extremely difficult to convince endocrinologists, when they've become so accustomed to dosing RAA insulin 15-20 minutes pre-meal for decades. If MannKind screws up the Phase 3 trial cohorts, it will likely be devastating to the company. Unfortunately at this point With Castagna as CEO I don’t expect anything to go well. If Dr Kendall can override Castagnas misguided directions he might get us through the phase 3 trial with results that leads to approval |
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Post by mango on Dec 21, 2019 22:06:14 GMT -5
Yes. That event happened to be reported early during the current pediatric trial. In fact, it may be happening more frequently than desired, so it's critical that Dr. Kendall makes certain that the timing of each dose is one of the data points recorded during the Phase 3 trial. It can be extremely difficult to convince endocrinologists, when they've become so accustomed to dosing RAA insulin 15-20 minutes pre-meal for decades. If MannKind screws up the Phase 3 trial cohorts, it will likely be devastating to the company. Unfortunately at this point With Castagna as CEO I don’t expect anything to go well. If Dr Kendall can override Castagnas misguided directions he might get us through the phase 3 trial with results that leads to approval Why are you insinuating that the Peds clinical trial has been a failure so far or something? Quite the opposite. FDA is even letting the length of time be nearly cut in half. Your post is just a bunch of FUD. Poster 1350-P: Safety and Pharmacokinetics of Technosphere Insulin in Pediatric PatientsPoster Highlights: • In pediatric patients, the rapid rise in insulin concentrations corresponded with early postprandial glucose control within the first hour post-dose. The profile is similar to that previously observed in adults. • Consistent with its safety profile in adults, Afrezza was generally well-tolerated in pediatric patients; most treatment emergent adverse events were of mild severity, and no severe hypoglycemia was observed. • These data will help guide the finalization of the protocol for a phase 3 safety and efficacy study. “We are excited to share the progress of the ongoing pediatric study program,” said David Kendall, M.D., Chief Medical Officer of MannKind. “As is well known, type 1 diabetes is often diagnosed in children and adolescents, and these individuals will continue to require insulin therapy throughout their lives. Evaluating as quickly as possible the potential use of Afrezza in children and adolescents as an option for mealtime insulin therapy is a top priority for MannKind.” An interim review of data from individuals participating in the second cohort shows that the single‑dose pharmacokinetic profile of insulin levels for this age group is consistent with the pattern seen in adults. In addition, dosing over one month demonstrated a safety profile that was also consistent with that observed in adults. As a result of these findings, MannKind and the study investigators are proceeding with enrollment of the third cohort of subjects. This third and final cohort will study Afrezza in children aged 4-7 years and will assess insulin levels, glucose changes, and the short-term safety and tolerability of multiple doses of Afrezza. “We are very pleased that we can extend the study to younger children who could benefit from the flexible dosing Afrezza provides and thankful for the families and investigators who have participated to date,” said David Kendall, M.D., Chief Medical Officer of MannKind. www.globenewswire.com/news-release/2019/06/09/1866093/0/en/MannKind-Presents-Positive-Afrezza-Clinical-Data-from-Three-Studies-at-ADA-79th-Scientific-Sessions.htmlwww.globenewswire.com/news-release/2019/07/31/1894774/0/en/Afrezza-Safety-and-Pharmacokinetics-Study-in-Pediatric-Patients-Opens-Enrollment-for-Cohort-3.html |
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Post by bababooey on Dec 22, 2019 12:46:19 GMT -5
Yes as I recall in the trials Afrezza was dosed the same as RAA’s meaning 30 mins or so before the meal which means it was almost out of the system by the time one ate. Matt once told me they had in hindsight put themselves at a disadvantage and it was lucky they got they received a non inferior label. Not only in the trials!! after Afrezza was launched by Sanofi the label was telling them to take it too early. A guy I worked with would take it 10 to 20 minutes before he would eat, then was afraid to take the follow up dose. I tried to tell him he was taking it too soon, and that he could just take more if he was still out of range, but he said it doesn’t work that way. They, (Sanofi), were just turning patients loose with no direction whatsoever. Because of the label instructing him wrong, the dreamboat caking up, and the cough, we lost him as a patient. Hard to Imagine a Company smart enough to get Afrezza approved would allow it to be handled so carelessly. MNKD, SNY, and the FDA are all to blame, what a shame. And now that people are figuring out how to really use Afrezza, it’s even more apparent how bad they screwed up. I just wonder how long it will take for the Healthcare System to finally realize how wrong they are to make it so hard to just get a prescription that’s covered by insurance. Eventually they’re all going to look either extremely crooked or dumb. 😎 I know your intentions are good but please avoid giving medical advice like this. Yeah it may work for some/many but this is not risk free. Hypoglycemia is still a real risk. |
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Post by lifebreath on Dec 22, 2019 13:16:04 GMT -5
Unfortunately at this point With Castagna as CEO I don’t expect anything to go well. If Dr Kendall can override Castagnas misguided directions he might get us through the phase 3 trial with results that leads to approval Why are you insinuating that the Peds clinical trial has been a failure so far or something? Quite the opposite. FDA is even letting the length of time be nearly cut in half. Your post is just a bunch of FUD. Poster 1350-P: Safety and Pharmacokinetics of Technosphere Insulin in Pediatric PatientsPoster Highlights: • In pediatric patients, the rapid rise in insulin concentrations corresponded with early postprandial glucose control within the first hour post-dose. The profile is similar to that previously observed in adults. • Consistent with its safety profile in adults, Afrezza was generally well-tolerated in pediatric patients; most treatment emergent adverse events were of mild severity, and no severe hypoglycemia was observed. • These data will help guide the finalization of the protocol for a phase 3 safety and efficacy study. “We are excited to share the progress of the ongoing pediatric study program,” said David Kendall, M.D., Chief Medical Officer of MannKind. “As is well known, type 1 diabetes is often diagnosed in children and adolescents, and these individuals will continue to require insulin therapy throughout their lives. Evaluating as quickly as possible the potential use of Afrezza in children and adolescents as an option for mealtime insulin therapy is a top priority for MannKind.” An interim review of data from individuals participating in the second cohort shows that the single‑dose pharmacokinetic profile of insulin levels for this age group is consistent with the pattern seen in adults. In addition, dosing over one month demonstrated a safety profile that was also consistent with that observed in adults. As a result of these findings, MannKind and the study investigators are proceeding with enrollment of the third cohort of subjects. This third and final cohort will study Afrezza in children aged 4-7 years and will assess insulin levels, glucose changes, and the short-term safety and tolerability of multiple doses of Afrezza. “We are very pleased that we can extend the study to younger children who could benefit from the flexible dosing Afrezza provides and thankful for the families and investigators who have participated to date,” said David Kendall, M.D., Chief Medical Officer of MannKind. www.globenewswire.com/news-release/2019/06/09/1866093/0/en/MannKind-Presents-Positive-Afrezza-Clinical-Data-from-Three-Studies-at-ADA-79th-Scientific-Sessions.htmlwww.globenewswire.com/news-release/2019/07/31/1894774/0/en/Afrezza-Safety-and-Pharmacokinetics-Study-in-Pediatric-Patients-Opens-Enrollment-for-Cohort-3.htmlMango if you have been investing in pharmaceutical companies long enough you would recognize this is just a standard press release and poster. Unfortunately this will have no bearing on the FDA decision to approve Afrezza for pediatric use. This is not meant to spread FUD as you claim, but to point out that Mike Castagna does not have the competency required to be CEO of Mannkind. Which is obvious to long time shareholders who follow the company closely. |
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Post by mnholdem on Dec 22, 2019 14:11:13 GMT -5
Not only in the trials!! after Afrezza was launched by Sanofi the label was telling them to take it too early. A guy I worked with would take it 10 to 20 minutes before he would eat, then was afraid to take the follow up dose. I tried to tell him he was taking it too soon, and that he could just take more if he was still out of range, but he said it doesn’t work that way. They, (Sanofi), were just turning patients loose with no direction whatsoever. Because of the label instructing him wrong, the dreamboat caking up, and the cough, we lost him as a patient. Hard to Imagine a Company smart enough to get Afrezza approved would allow it to be handled so carelessly. MNKD, SNY, and the FDA are all to blame, what a shame. And now that people are figuring out how to really use Afrezza, it’s even more apparent how bad they screwed up. I just wonder how long it will take for the Healthcare System to finally realize how wrong they are to make it so hard to just get a prescription that’s covered by insurance. Eventually they’re all going to look either extremely crooked or dumb. 😎 I know your intentions are good but please avoid giving medical advice like this. Yeah it may work for some/many but this is not risk free. Hypoglycemia is still a real risk. Frankly, there are long time MannKind shareholders who are much more knowledgeable about correct dosing of Afrezza than many doctors. RSR was absolutely correct with his advice, which was no different than if he had noticed his colleague holding the inhaler upside down which spills the powder. |
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Post by rockstarrick on Dec 22, 2019 18:22:42 GMT -5
I know your intentions are good but please avoid giving medical advice like this. Yeah it may work for some/many but this is not risk free. Hypoglycemia is still a real risk. Frankly, there are long time MannKind shareholders who are much more knowledgeable about correct dosing of Afrezza than many doctors. RSR was absolutely correct with his advice, which was no different than if he had noticed his colleague holding the inhaler upside down which spills the powder. Yeah, I don’t do stupid shit just because the professionals can’t get it right. What’s worse, a healthcare provider telling you to use it incorrectly, or the Bass Player telling you to use it the way all Afrezzausers are having life changing success. if it makes you feel any better, I also taught this guy how to shotgun a beer 🍺 Merry Christmas Everybody ✌🏻😎 |
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Post by cretin11 on Dec 22, 2019 23:00:36 GMT -5
Bass players don’t speak up often, but when they do, the rest of us listen. 😆
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