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Post by Clement on Mar 5, 2024 8:21:09 GMT -5
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Post by harryx1 on Mar 5, 2024 11:45:49 GMT -5
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Post by harryx1 on Mar 5, 2024 12:06:08 GMT -5
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Post by dh4mizzou on Mar 5, 2024 12:13:18 GMT -5
Sorry. What are KOLs
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Post by harryx1 on Mar 5, 2024 12:18:32 GMT -5
KOLs = Key Opinion Leaders
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Post by hellodolly on Mar 5, 2024 13:12:20 GMT -5
KOLs = Key Opinion Leaders Harry, just looking at Dr. Hirsch bio. Impressive. Will KOLs be influenced by Hirsch if what he's finding, in the initial work, is promising? More work to do, sure but...needle moving? I'm expecting positive outcomes based on the limited data so far, to move the needle and create some price action volatility in the short term. Thoughts? |
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Post by sayhey24 on Mar 6, 2024 7:45:52 GMT -5
KOLs = Key Opinion Leaders Harry, just looking at Dr. Hirsch bio. Impressive. Will KOLs be influenced by Hirsch if what he's finding, in the initial work, is promising? More work to do, sure but...needle moving? I'm expecting positive outcomes based on the limited data so far, to move the needle and create some price action volatility in the short term. Thoughts? Hirsch has been involved with afrezza from near day 1. After Dave Kendall left we all complained Mike better start paying some "thought leaders" to get the word out. Mike got Irl back involved. Irl is huge in the diabetes industry. He can move the SoC. Irl is the "study chair" on the Inhale-3 study. This study is going to show great results. The good news is this segment of the diabetes market will actually be able to get insurance coverage. They will be able to show another medical condition like lipohypertrophy to get through the pre auth process and get insurance coverage. www.nytimes.com/2007/11/16/business/16mannkind.html |
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Post by sayhey24 on Mar 6, 2024 8:41:09 GMT -5
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Post by harryx1 on Mar 6, 2024 10:39:24 GMT -5
Will the new term stick and become a new goal? If it does, what insulin would be best suited to achieve that goal?
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Post by MnkdWASmyRtrmntPlan on Mar 6, 2024 11:13:43 GMT -5
KOLs = Key Opinion Leaders Harry, just looking at Dr. Hirsch bio. Impressive. Will KOLs be influenced by Hirsch if what he's finding, in the initial work, is promising? More work to do, sure but...needle moving? I'm expecting positive outcomes based on the limited data so far, to move the needle and create some price action volatility in the short term. Thoughts? It's been my observation that the only thing that moves the MNKD stock needle is Money, money, money, money (ie, earnings) Studies, Events, Presentations, ADA, Social Media, Flying hamburgers, partnerships and even Thought-leaders (aka KOL's) do nothing. Which is really probably true with all stocks. |
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Post by sayhey24 on Mar 6, 2024 11:56:14 GMT -5
Will the new term stick and become a new goal? If it does, what insulin would be best suited to achieve that goal? They presented this last year. Maybe if they keep saying it, it will. We have been saying 70 - 140 here on Proboards for years. Without afrezza TITR is a real challenge. Lets hope it does stick and becomes the new SoC. diatribe.org/time-tight-range-new-diabetes-goal |
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Post by sayhey24 on Mar 6, 2024 12:09:57 GMT -5
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Post by kite on Mar 11, 2024 5:12:32 GMT -5
INHALE-3 Study’s Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumpsinvestors.mannkindcorp.com/news-releases/news-release-details/inhale-3-studys-initial-meal-challenge-results-comparing- Post-meal hyperglycemia was significantly reduced by 20% with inhaled insulin compared with rapid-acting insulin delivered through MDI or insulin pumps
- Subjects utilizing inhaled insulin experienced a 22% decrease in mean glucose excursions in the first two hours compared to the standard of care
- 17-week primary endpoint results will be presented during a 90-minute symposium at the American Diabetes Association’s Scientific Sessions in June
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced initial meal challenge data from INHALE-3 that was presented by Dr. Irl B. Hirsch at the 17th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Florence on March 8th. INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care. The statistically significant findings included: - Subjects utilizing inhaled insulin experienced significantly reduced post-meal hyperglycemia, compared with those who used subcutaneous rapid-acting analogues (RAA) delivered by MDI or pumps
Area under the curve (AUC; 180 mg/dL) was reduced by 20%
- Inhaled insulin subjects demonstrated significantly lower glucose excursions from baseline
Mean glucose excursions were reduced by 22% - In the inhaled insulin group, mean glucose levels peaked 15 minutes sooner than in the standard of care group despite inhaled insulin being given at start of the meal vs. RAA being administered 5-15 minutes prior to the meal
“Clinician have been seeking options for people living with diabetes in hopes of identifying treatments that provide improved mealtime control,” said Dr. Hirsch, Professor of Medicine and Diabetes Treatment and Teaching Chair at the University of Washington and the INHALE-3 Study Protocol Chair. “It is exciting to share data from this study’s standardized meal challenge, demonstrating inhaled insulin can help address this unmet need.” The 17-week endpoint results from INHALE-3 will be presented Saturday, June 22, during a symposium at the American Diabetes Association’s 84th Scientific Sessions in Orlando. “One of the challenges of inhaled insulin adoption has been under-dosing when converting from injectable insulin, which causes patients to experience hyperglycemia,” said Dr. Kevin Kaiserman, Senior Vice President, Clinical Development and Medical Affairs for MannKind Corporation. “In this large, randomized trial utilizing more appropriate dose conversion, we are excited to see meal challenge results support the safety and efficacy of inhaled insulin from the start.” INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. The study, which enrolled 141 patients (123 randomized), assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses (mealtime and corrections). Subjects utilizing inhaled insulin received a higher initial conversion dose than in the current label. Both arms utilized continuous glucose monitoring to assess glucose control. A1c levels were obtained at baseline, 17 and 30-weeks. For the meal challenge, the inhaled insulin group took an inhaled insulin dose immediately prior to a standardized meal (a 240 calorie nutritional shake) whereas those using usual care used RAA 5-15 minutes prior to the meal. More information on the INHALE-3 study is available at: ClinicalTrials.gov(NCT05904743).
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Post by peppy on Mar 11, 2024 6:50:34 GMT -5
"In the inhaled insulin group, mean glucose levels peaked 15 minutes sooner than in the standard of care group despite inhaled insulin being given at start of the meal vs. RAA being administered 5-15 minutes prior to the meal
One of the challenges of inhaled insulin adoption has been under-dosing when converting from injectable insulin, which causes patients to experience hyperglycemia,” said Dr. Kevin Kaiserman, Senior Vice President, Clinical Development and Medical Affairs for MannKind Corporation. “In this large, randomized trial utilizing more appropriate dose conversion, we are excited to see meal challenge results support the safety and efficacy of inhaled insulin from the start.”
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MNKD used the "The dose optimization study is the Afrezza dynamic dosing study, which we're calling [AED-1] study. This protocol is very close to finalization and we're aiming for a July/August start with the possible Q4 completion, date available soon after. "
Mar 14, 2018 a. remember the dose optimization study? Mike saying, "if Afrezza is dosed correctly a second dose at 1 hour shouldn't be needed." by memory from the conference call.
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Post by dh4mizzou on Mar 11, 2024 7:30:33 GMT -5
Hmmm. Seems like someone may like the study results that were released 2 hours ago.
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