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Post by sellhighdrinklow on May 8, 2020 9:04:43 GMT -5
DXCM stock is trading at $400 per share now. $37 billion market cap. They could acquire mnkd for stock, drop in bucket. Their CEO , Kevin Sayer, said 4 years ago, he'd never seen anything like Afrezza with the way it controls blood sugar. No brainer 🤑🤓😁
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Post by rfogel on May 8, 2020 9:06:11 GMT -5
I was under the impression that Mannkind was abandoning the Type 2 market.
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Post by mango on May 8, 2020 9:27:45 GMT -5
The bar was set very low by stating there was no expectation of A1C improvement. I say there will be significant improvement in A1C . Who stated there was no expectation of A1c improvement?
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Post by olderteampt on May 8, 2020 9:29:25 GMT -5
The right device, the right medicine, the right delivery system = The right choice. No one can match our time in range.
DXCM + MNKD
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Post by porkini on May 8, 2020 9:33:33 GMT -5
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Post by cjc04 on May 8, 2020 10:11:06 GMT -5
Couldn’t help but go look at a 10 year chart of Dexcom . 😳
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Post by sellhighdrinklow on May 8, 2020 10:14:53 GMT -5
The bar was set very low by stating there was no expectation of A1C improvement. I say there will be significant improvement in A1C . Who stated there was no expectation of A1c improvement? Brief Summary: The purpose of this study is to collect CGM, A1c and Quality of Life data in subjects with Type 2 diabetes before and after transitioning from Multiple Daily Injections to Basal plus Bolus with Afrezza® inhaled insulin. The primary objective is to evaluate the percentage of time spent in goal range without significant hypoglycemia. Additional objectives include evaluation of A1c and Quality of Life data. The expected outcomes are improvement of time in range, no change or improvement in A1c and favorable Quality of Life data
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Post by mango on May 8, 2020 10:18:34 GMT -5
Who stated there was no expectation of A1c improvement? Brief Summary: The purpose of this study is to collect CGM, A1c and Quality of Life data in subjects with Type 2 diabetes before and after transitioning from Multiple Daily Injections to Basal plus Bolus with Afrezza® inhaled insulin. The primary objective is to evaluate the percentage of time spent in goal range without significant hypoglycemia. Additional objectives include evaluation of A1c and Quality of Life data. The expected outcomes are improvement of time in range, no change or improvement in A1c and favorable Quality of Life data no change or improvement in A1cI interpret that as in either: 1. No change or 2. Improvement I take you interpret it as no change and no improvement? Remember, the reason why we see such drastic differences in A1c drops in these clinical trials using RAAs compared to Afrezza is because RAAs cause significantly more hypos and significantly more time in hypos, thus dramatically lowering (artificially) the A1c, giving it a false impression that RAAs are better. This study, as well as the STAT, is proving that old age thinking wrong. TIR and less hypos > A1c A1c will balance itself out to the body's normal level when glucose homeostasis is restored (improved TIR and less hypos, seen with Afrezza).
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Post by sellhighdrinklow on May 8, 2020 10:27:08 GMT -5
Brief Summary: The purpose of this study is to collect CGM, A1c and Quality of Life data in subjects with Type 2 diabetes before and after transitioning from Multiple Daily Injections to Basal plus Bolus with Afrezza® inhaled insulin. The primary objective is to evaluate the percentage of time spent in goal range without significant hypoglycemia. Additional objectives include evaluation of A1c and Quality of Life data. The expected outcomes are improvement of time in range, no change or improvement in A1c and favorable Quality of Life data no change or improvement in A1cI interpret that as in either: 1. No change or 2. Improvement I take you interpret it as no change and no improvement? Remember, the reason why we see such drastic differences in A1c drops in these clinical trials using RAAs compared to Afrezza is because RAAs cause significantly more hypos and significantly more time in hypos, thus dramatically lowering (artificially) the A1c, giving it a false impression that RAAs are better. This study, as well as the STAT, is proving that old age thinking wrong. TIR and less hypos > A1c A1c will balance itself out to the body's normal level when glucose homeostasis is restored (improved TIR and less hypos, seen with Afrezza). Upon further review, I believe you are correct. Thanks, Mango.
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Post by matt on May 8, 2020 12:49:19 GMT -5
Normally when patients are on a trial, especially one where the drug is already approved (like Afrezza) or one that is about to be approved, the patients have the option to continue on the trial therapy if they and their physician agree. This is provided as a way to entice patients to participate in enrollment, and for much the same reason you see some study protocols that allow cross-over from one test arm to another. When the cross-over arm involves increasing the number of patients exposed to an entirely novel test drug that is usually documented in the results, especially if it improves the efficacy results for the tested drug. I cannot recall a single study that documented which therapy patients chose at the end of a study when both drugs were already approved. That doesn't mean it has never happened, PubMed adds more than 2 million new articles a year and I rarely read more than about 600 in a year, but it certainly isn't typical. Every study tests a hypothesis, but which drug patients prefer is generally not considered when formulating the hypothesis.
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Post by robbmo on May 8, 2020 14:15:01 GMT -5
no change or improvement in A1cI interpret that as in either: 1. No change or 2. Improvement I take you interpret it as no change and no improvement? Remember, the reason why we see such drastic differences in A1c drops in these clinical trials using RAAs compared to Afrezza is because RAAs cause significantly more hypos and significantly more time in hypos, thus dramatically lowering (artificially) the A1c, giving it a false impression that RAAs are better. This study, as well as the STAT, is proving that old age thinking wrong. TIR and less hypos > A1c A1c will balance itself out to the body's normal level when glucose homeostasis is restored (improved TIR and less hypos, seen with Afrezza). Upon further review, I believe you are correct. Thanks, Mango. Maybe it is my optimistic nature, but I read no change or improvement in A1c as "at least as good or better." :-)
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Post by falconquest on May 8, 2020 15:08:42 GMT -5
Couldn’t help but go look at a 10 year chart of Dexcom . 😳 And that is a perfect example of the opportunity cost of owning MNKD.
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Post by sayhey24 on May 9, 2020 13:00:47 GMT -5
I was under the impression that Mannkind was abandoning the Type 2 market. I believe what Mike said was MNKD was going to focus on the T1 market in 2020. The biggest win for T2 diabetics will be when afrezza is adopted as the first step in the standard of care along with lose a few pounds and take a daily walk. What is now clear is that getting SOC changes will be very difficult and wont even start until there is large study after large study showing how reducing post prandial glucose excursions and getting the PWD back to their sub-140 baseline significantly reduces diabetes related complications such as heart disease and vascular degeneration. So far its not proving out to be the easiest job Dr. Kendall said he ever had but I hope Dr. Kendall ends up being correct. I think Mike thought the India study would be a first step in getting a large study and hoped the Indian government would allow the Libre to be used. Not being an approved device in India this request was denied. Now with the virus, I am not sure the status of this study. The Dexcom study will be one very small step in the right direction but moving the diabetes community will require numerous large studies which will take years. I had always thought this was not going to be the case but moving the community has proven very difficult. Positioning afrezza as a T1 rescue tool is an easy sell as an add on therapy. T1's then transitioning to use it as their prandial then becomes an easier sell. Who knows maybe the pediatric study will be completed at some point and the kids will never have to use current RAAs. The really big market for both Dexcom and MNKD is with the T2s. Developing that market is challenging but Dexcom sure can help.
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Post by mango on May 9, 2020 16:38:13 GMT -5
I was under the impression that Mannkind was abandoning the Type 2 market. I believe what Mike said was MNKD was going to focus on the T1 market in 2020. The biggest win for T2 diabetics will be when afrezza is adopted as the first step in the standard of care along with lose a few pounds and take a daily walk. What is now clear is that getting SOC changes will be very difficult and wont even start until there is large study after large study showing how reducing post prandial glucose excursions and getting the PWD back to their sub-140 baseline significantly reduces diabetes related complications such as heart disease and vascular degeneration. So far its not proving out to be the easiest job Dr. Kendall said he ever had but I hope Dr. Kendall ends up being correct. I think Mike thought the India study would be a first step in getting a large study and hoped the Indian government would allow the Libre to be used. Not being an approved device in India this request was denied. Now with the virus, I am not sure the status of this study. The Dexcom study will be one very small step in the right direction but moving the diabetes community will require numerous large studies which will take years. I had always thought this was not going to be the case but moving the community has proven very difficult. Positioning afrezza as a T1 rescue tool is an easy sell as an add on therapy. T1's then transitioning to use it as their prandial then becomes an easier sell. Who knows maybe the pediatric study will be completed at some point and the kids will never have to use current RAAs. The really big market for both Dexcom and MNKD is with the T2s. Developing that market is challenging but Dexcom sure can help. Honestly, it should be common sense that reducing the PPGEs and maintaining a really tight TIR (thus restoring glucose homeostasis) would lead to a significant reduction in diabetes related complications—considering those complications are caused by the PPGEs, prolonged hyperglycemia, glucose fluctuations over 140, and so on. By restoring the FPIR with Afrezza we are fixing the underlying defect. It will be a very long time, millions of dollars spent and thousands of patients continuing to receive inadequate and medically incorrect care before the SoC catches up.
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Post by akemp3000 on May 9, 2020 23:01:50 GMT -5
The length of time it takes to change SoC won't necessarily correlate to the past. Today's society sees change much faster than ever before due to technology. Depending on the outcome of the study that's presented, it's difficult to imagine leading endo's and diabetes thought leaders sitting on life changing results. I'm not saying it will happen quickly, just that the past doesn't always represent the future. Let's hope.
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