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Post by nylefty on Mar 28, 2020 15:22:25 GMT -5
apnews.com/b21a296383694c6726d03e027134daf1RIO DE JANEIRO (AP) — Even as coronavirus cases mount in Latin America’s largest nation, Brazilian President Jair Bolsonaro has staked out the most deliberately dismissive position of any major world leader, calling the pandemic a momentary, minor problem and saying strong measures to contain it are unnecessary. Bolsonaro says his response to the disease matches that of President Donald Trump in the U.S., but the Brazilian leader has gone further, labeling the virus as “a little flu” and saying state governors’ aggressive measures to halt the disease were crimes. Wrong thread. No, because Afrezza sales in Brazil will be affected by the virus and Brazilian sales have been listed as one of the MannKind catalysts this year.
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Post by awesomo on Mar 28, 2020 15:34:48 GMT -5
Brazil is not a catalyst, if it was, Castagna would have been talking about it in details in his investor pitches, earnings calls, etc. Instead we get vague answers or crickets. If anything, it will allow them to offload supply of Afrezza and pontentially lower COGS a bit, but nothing more than that.
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Post by mnkdfann on Mar 29, 2020 10:48:01 GMT -5
Brazil is not a catalyst, if it was, Castagna would have been talking about it in details in his investor pitches, earnings calls, etc. Instead we get vague answers or crickets. If anything, it will allow them to offload supply of Afrezza and pontentially lower COGS a bit, but nothing more than that. That may be, but it was listed as being one in the very first post in this thread. No one really seriously argued against that until your post.
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Post by MnkdWASmyRtrmntPlan on Mar 29, 2020 13:29:10 GMT -5
Right. The only thing Brazil will be is interesting how well it sells at such a low price.
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Post by mnkdfann on Apr 1, 2020 14:14:51 GMT -5
Right. The only thing Brazil will be is interesting how well it sells at such a low price. Given Mannkind's luck, I am surprised Bolsonaro has not yet blamed the Afrezza Technosphere inhalers for the spread of Covid-19 down there.
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Post by morfu on Apr 1, 2020 14:59:24 GMT -5
Right. The only thing Brazil will be is interesting how well it sells at such a low price. Are there any recent numbers available on that? (Preferably in English.. )
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Post by MnkdWASmyRtrmntPlan on Apr 2, 2020 19:26:43 GMT -5
Right. The only thing Brazil will be is interesting how well it sells at such a low price. Given Mannkind's luck, I am surprised Bolsonaro has not yet blamed the Afrezza Technosphere inhalers for the spread of Covid-19 down there. LOL, well at least it's good that we haven't started selling in China. Otherwise, they would have blamed MNKD for STARTING Covid-19.
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Post by MnkdWASmyRtrmntPlan on Apr 2, 2020 19:43:25 GMT -5
Right. The only thing Brazil will be is interesting how well it sells at such a low price. Are there any recent numbers available on that? (Preferably in English.. )
English numbers? I'm not sure what numbers you are referring to. I thought you meant how much $ they are selling Rx's for, which I thought was why you said English (but meant dollars). But, you said "recent", so I'm thinking you mean $ales. So, the Brazilian prescription price has been detailed in previous threads and can probably be found by searching threads for "brazil" and "price". I have not seen any sales numbers and I wonder if we will ever see them. But, that has probably been discussed in previous threads, too.
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Post by mango on May 8, 2020 2:36:13 GMT -5
Looks like the MannKind/Dexcom clinical trial results will be presented at this year's ADA meeting! 🚀 (pic is from addiction2money on ST)
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Post by mango on May 8, 2020 8:07:23 GMT -5
This study will further strengthen the scientific knowledge, abilities and capabilities of Afrezza inhaled mealtime insulin, as well as, continued exploration into real-time glucose control—further establishing Afrezza + CGM as the Gold Standard of real-time glucose control for superior TIR—demonstrating the ease and simplicity of which people with diabetes can achieve a life more humann, now thanks to Afrezza and CGMs. You will notice that A1c is taking a back seat as a secondary outcome measure. This is because A1c is a proxy, and does not accurately reflect glucose homeostasis—TIR does. A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily InjectionsThe 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• Primary Outcome Measures: 1. Time In Range [ Time Frame: Week 2 to End of Study ]Evaluation of percentage of time spent in goal range, above (hyperglycemic range) and below (hypoglycemic range) via CGM system from visit week 2 baseline to final study visit with inhaled insulin (Afrezza®).
 2. Hypoglycemia [ Time Frame: Week 2 to Week 16 ]Incidence of significant hypoglycemic events • Secondary Outcome Measures: 1. Hemoglobin A1c [ Time Frame: Week 2 to Week 16 ]Evaluation of A1c from visit week 2 baseline to final study visit
 2. Quality of Life Questionnaires [ Time Frame: Screening to Week 16 ]Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit. clinicaltrials.gov/ct2/show/NCT04125082?term=MannKind&recrs=abdf&draw=2&rank=4
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Post by sellhighdrinklow on May 8, 2020 8:32:07 GMT -5
This study will further strengthen the scientific knowledge, abilities and capabilities of Afrezza inhaled mealtime insulin, as well as, continued exploration into real-time glucose control—further establishing Afrezza + CGM as the Gold Standard of real-time glucose control for superior TIR—demonstrating the ease and simplicity of which people with diabetes can achieve a life more humann, now thanks to Afrezza and CGMs. You will notice that A1c is taking a back seat as a secondary outcome measure. This is because A1c is a proxy, and does not accurately reflect glucose homeostasis—TIR does. A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily InjectionsThe 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• Primary Outcome Measures: 1. Time In Range [ Time Frame: Week 2 to End of Study ]Evaluation of percentage of time spent in goal range, above (hyperglycemic range) and below (hypoglycemic range) via CGM system from visit week 2 baseline to final study visit with inhaled insulin (Afrezza®).
 2. Hypoglycemia [ Time Frame: Week 2 to Week 16 ]Incidence of significant hypoglycemic events • Secondary Outcome Measures: 1. Hemoglobin A1c [ Time Frame: Week 2 to Week 16 ]Evaluation of A1c from visit week 2 baseline to final study visit
 2. Quality of Life Questionnaires [ Time Frame: Screening to Week 16 ]Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit. clinicaltrials.gov/ct2/show/NCT04125082?term=MannKind&recrs=abdf&draw=2&rank=4This is a reason to load up on MNKD stock, IMHO. If you don't believe me, ask mytakeonit .
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Post by sellhighdrinklow on May 8, 2020 8:36:55 GMT -5
With the price of Dexcom stock where it is, DXCM might have serious intentions of acquiring MNKD or at least taking a significant stake in the company. I think we all know the results of this study will prove absolute superiority of Afrezza use in the largest population of diabetics, the Type 2s.
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Post by sellhighdrinklow on May 8, 2020 8:40:17 GMT -5
With the price of Dexcom stock where it is, DXCM might have serious intentions of acquiring MNKD or at least taking a significant stake in the company. I think we all know the results of this study will prove absolute superiority of Afrezza use in the largest population of diabetics, the Type 2s. DXCM market cap is $37 BILLION. $4 Billion for MNKD via their stock is a drop in their diabetic bucket !
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Post by mango on May 8, 2020 8:41:34 GMT -5
This study will further strengthen the scientific knowledge, abilities and capabilities of Afrezza inhaled mealtime insulin, as well as, continued exploration into real-time glucose control—further establishing Afrezza + CGM as the Gold Standard of real-time glucose control for superior TIR—demonstrating the ease and simplicity of which people with diabetes can achieve a life more humann, now thanks to Afrezza and CGMs. You will notice that A1c is taking a back seat as a secondary outcome measure. This is because A1c is a proxy, and does not accurately reflect glucose homeostasis—TIR does. A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily InjectionsThe 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• Primary Outcome Measures: 1. Time In Range [ Time Frame: Week 2 to End of Study ]Evaluation of percentage of time spent in goal range, above (hyperglycemic range) and below (hypoglycemic range) via CGM system from visit week 2 baseline to final study visit with inhaled insulin (Afrezza®).
 2. Hypoglycemia [ Time Frame: Week 2 to Week 16 ]Incidence of significant hypoglycemic events • Secondary Outcome Measures: 1. Hemoglobin A1c [ Time Frame: Week 2 to Week 16 ]Evaluation of A1c from visit week 2 baseline to final study visit
 2. Quality of Life Questionnaires [ Time Frame: Screening to Week 16 ]Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit. clinicaltrials.gov/ct2/show/NCT04125082?term=MannKind&recrs=abdf&draw=2&rank=4This is a reason to load up on MNKD stock, IMHO. If you don't believe me, ask mytakeonit . This doesn't hold the weight of a large superiority clinical trial, but it is Phase 4 clinical trial and small participant pools are totally normal and acceptable in Phase 4 studies. This will help strengthen the T2 market approach, and benefits both Dexcom and MannKind to have good results—which they do, hence, they are being presented at this year's ADA. I can see Dexcom wanting to continue working with MannKind, with or without a partnership at stake.
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Post by sellhighdrinklow on May 8, 2020 8:56:22 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 .
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