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Post by boomboom on Jun 10, 2020 11:14:08 GMT -5
Abstract is here: diabetes.diabetesjournals.org/content/69/Supplement_1/990-PSummary: The study failed to achieve its primary endpoint of significant increase of time spent in glycemic goal range. Other benefits were seen as detailed further in the abstract. In other news: diabetes.diabetesjournals.org/content/69/Supplement_1/1023-PSummary: Dosing with Afrezza was compared to injectable prandial insulin and found that to achieve the same glycemic control it takes 1.3 to 2.5 times as many units of Afrezza to get the same result as injectable insulins. This is not news to anybody who follows MNKD, but it does have cost of therapy implications if an insurer is comparing the cost of administering 10 units of injectable to the cost of administering 20 units of Afrezza. To me these studies will either not move the needle at all or move the needle in the wrong direction from a shareholder/investor perspective. I find it unfortunate and mind-boggling that a controlled study was not able to demonstrate what users in the real world have been experiencing for the last 10 years. You would think the study would have focused on ensuring participants could replicate how real-world users are achieving superior TIR if that was the focus of this trial. Or am I missing something? I am trying to figure out if this is a big miss from those who designed the study or are their restrictions that will not allow participants to achieve what actual users are achieving. |
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Post by peppy on Jun 10, 2020 11:21:33 GMT -5
Abstract is here: diabetes.diabetesjournals.org/content/69/Supplement_1/990-PSummary: The study failed to achieve its primary endpoint of significant increase of time spent in glycemic goal range. Other benefits were seen as detailed further in the abstract. In other news: diabetes.diabetesjournals.org/content/69/Supplement_1/1023-PSummary: Dosing with Afrezza was compared to injectable prandial insulin and found that to achieve the same glycemic control it takes 1.3 to 2.5 times as many units of Afrezza to get the same result as injectable insulins. This is not news to anybody who follows MNKD, but it does have cost of therapy implications if an insurer is comparing the cost of administering 10 units of injectable to the cost of administering 20 units of Afrezza. To me these studies will either not move the needle at all or move the needle in the wrong direction from a shareholder/investor perspective. I find it unfortunate and mind-boggling that a controlled study was not able to demonstrate what users in the real world have been experiencing for the last 10 years. You would think the study would have focused on ensuring participants could replicate how real-world users are achieving superior TIR if that was the focus of this trial. Or am I missing something? I am trying to figure out if this is a big miss from those who designed the study or are their restrictions that will not allow participants to achieve what actual users are achieving. "Dosing with Afrezza was compared to injectable prandial insulin and found that to achieve the same glycemic control it takes 1.3 to 2.5 times as many units of Afrezza to get the same result as injectable insulins.:No hypos? No stacking.Same glycemic control, HA1c? or after meal..... |
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Post by joeypotsandpans on Jun 10, 2020 12:04:00 GMT -5
I see that Kevinmik has posted Dexcom trial abstracts on Stocktwits more than an hour ago. Pretty big deal. Not a peep about it over here, bc nobody posts here anymore. I know some have changed their tune on management, but what am I missing? Some "know (first hand) what they own" and don't need to follow Kevinmik etc.  . Some have locked up their shares and will let things take their natural course. Others continue to respond to detractors. Then there are those who are tortured and cannot book a loss and move on or have booked a loss and hang around to instigate. That is what you're missing |
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Post by mytakeonit on Jun 10, 2020 13:03:33 GMT -5
AND ... there are those who are loading up all the cheap shares now ... before the run up later. (Today's price move is nice, but not the run up.)
But, that's mytakeonit
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Post by sayhey24 on Jun 10, 2020 18:41:49 GMT -5
"Patients treated with inhaled insulin with background basal insulin for 14 weeks experienced significant reduction of A1c and significant improvements of Useful, Freeing, and Difficult QoL subdomains compared to baseline". That was not the primary target. The aim was to prove that Afrezza improved TIR and the study failed at that. The A1c evidence will get disregarded for two reasons; it was not the focus of the trial, and it runs counter to trials that have an order of magnitude more participants that say it is not better. In a clash like that the bigger trial always wins. That poster is a washout. The second poster is far more significant. For years we have talked on this board the importance of TIR. Some have argued on this board that the community as a whole don't understand TIR and the only important number is A1C. Fact is I don't think the importance of TIR has been discussed more than right here on MNKD ProBoards. We also know 180 is way to high to limited vascular damage. Well now we have it. A study which backfired on TIR but gave us outstanding results which show significant reduction of A1C. What would afrezza be today if the headlines of the Affinity 1 Study said afrezza shows significant A1c reduction over RAAs? Now how could we have significant A1c reduction with a mealtime insulin? The time period of action for afrezza is when someone is awake and really only for about 2hrs after a meal. Assuming 3 meals afrezza's direct ability to change A1c is 6 hours, i.e. "Stopping the Spike" and getting the PWD back to baseline asap. I guess we have to wait for the paper and hopefully we will see AGPs as part of the paper. I suspect the TIR used with the upper bound of 180 was over a 24hr period and was not limited to the hours someone is awake lets say 8am to 10pm. Those sleeping hours are the job of the basal. At the same time seeing a significant A1c reduction afrezza must have brought the PWDs immediately down to their baseline of lets say 100 and kept them there while the RAA PWDs where hanging around the upper bound of 180. My opinion is the study design was flawed from the start if the goal was a 24 TIR against an RAA. All insulin works given enough time and 180 is a very high bound when we know 2 hours over 140 cause vascular damage. A TIR study for afrezza should be limited to the hours the PWD is awake. What will be interesting will be seeing the AGPs and why afrezza reduced A1c. Moreover, the community could care less about TIR. All they still care about is A1c and if thats the case MNKD gets a HUGE backhanded win. |
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Post by sayhey24 on Jun 10, 2020 18:48:36 GMT -5
I agree that getting the label changed is important to delivering efficacy. Will MNKD deliver more units for the same price, or will there be a comparable increase in pricing? Given that Afrezza is already the most expensive option in the market, bumping the price by any significant amount will be counterproductive. Which begs the question of what is the true incremental cost of Afrezza in various dosage forms. I would think that the cost of the insulin and FDKP particles would have to increase proportionately, but the other costs (inhaler, cartridge, packaging, overhead) could stay approximately the same. I think MNKD missed the boat. They should have labeled the cartridges Small, Medium, Large and maybe an XL down the road? This would make the diabetics avoid comparing units and the anxiety of over dosing. The greatest mistake Al made was trying to address the Exubera dosing difficulty and thinking calling the cartridges units would make things simpler. All it did was make a huge mess. We have talked about this on this board for years. IMO this was the greatest marketing blunder of afrezza. Small, Medium and Large is what Mike needs to get it changed to and if he makes the 2U for the kids its XS. Come on Mike, we have had this discussion. |
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Post by falconquest on Jun 10, 2020 20:49:32 GMT -5
AND ... there are those who are loading up all the cheap shares now ... before the run up later. (Today's price move is nice, but not the run up.) But, that's mytakeonit I know it won't matter to you in the least Mr. takeonit but there are plenty of us who have been here for years that employed your strategy and it still hasn't worked. We have been there and done that so your words ring hollow with us. Mannkind will only prosper when they can figure out how to (really) sell Afrezza. In the interim, you're free to keep grabbing those cheap shares despite how naive that sounds to many of us. Just an FYI. |
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Post by pat on Jun 10, 2020 20:55:58 GMT -5
AND ... there are those who are loading up all the cheap shares now ... before the run up later. (Today's price move is nice, but not the run up.) But, that's mytakeonit I know it won't matter to you in the least Mr. takeonit but there are plenty of us who have been here for years that employed your strategy and it still hasn't worked. We have been there and done that so your words ring hollow with us. Mannkind will only prosper when they can figure out how to (really) sell Afrezza. In the interim, you're free to keep grabbing those cheap shares despite how naive that sounds to many of us. Just an FYI. Buying shares at these prices doesn’t sound hollow or naive to me. And I’ve been in the stock for like 10 years now. Does that mean that I’ve been there and done that too? Do I qualify to be in the old and wise club? |
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Post by falconquest on Jun 10, 2020 20:59:40 GMT -5
I know it won't matter to you in the least Mr. takeonit but there are plenty of us who have been here for years that employed your strategy and it still hasn't worked. We have been there and done that so your words ring hollow with us. Mannkind will only prosper when they can figure out how to (really) sell Afrezza. In the interim, you're free to keep grabbing those cheap shares despite how naive that sounds to many of us. Just an FYI. Buying shares at these prices doesn’t sound hollow or naive to me. And I’ve been in the stock for like 10 years now. Does that mean that I’ve been there and done that too? Do I qualify to be in the old and wise club? You're nearly there, keep going and you'll get it!  |
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Post by mytakeonit on Jun 10, 2020 21:26:21 GMT -5
Gotta love falcon ... nobody employed "my strategy" except for maybe kite and mango because no one has sent me $20. For your "free info" ... I've been churning and burning shares and all my new shares haven't cost me any additional capital. So I'm not worried about anything. But, I do wonder what your "quest" is by consistently pointing me out?
So yes, you can string us along with your green hair and say what you will. You should also bring along some of your buds next time.
But, that's mytakeonit
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Post by falconquest on Jun 10, 2020 21:33:53 GMT -5
Gotta love falcon ... nobody employed "my strategy" except for maybe kite and mango because no one has sent me $20. For your "free info" ... I've been churning and burning shares and all my new shares haven't cost me any additional capital. So I'm not worried about anything. But, I do wonder what your "quest" is by consistently pointing me out?So yes, you can string us along with your green hair and say what you will. You should also bring along some of your buds next time. But, that's mytakeonit Really? Quite frankly I don't believe I have ever bothered to reply to you or point out anything you say but if that's what you want to go with then carry on. In keeping with the spirit of the thread, that's just my observation. |
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Post by agedhippie on Jun 10, 2020 22:06:20 GMT -5
... My opinion is the study design was flawed from the start if the goal was a 24 TIR against an RAA. All insulin works given enough time and 180 is a very high bound when we know 2 hours over 140 cause vascular damage. A TIR study for afrezza should be limited to the hours the PWD is awake. What will be interesting will be seeing the AGPs and why afrezza reduced A1c. Moreover, the community could care less about TIR. All they still care about is A1c and if thats the case MNKD gets a HUGE backhanded win. Far bigger flaws are that it only had 25 people in the trial (4 of whom dropped out), and there was no RAA arm to show that the HbA1c gain was from the use of Afrezza and not the use of CGMs (there is already solid data showing significant HbA1c reduction simply from using CGMs). That's why the A1c part will not matter. The aim was to prove TIR and it failed which is actually going backwards from STAT. |
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Post by mytakeonit on Jun 11, 2020 0:59:52 GMT -5
Ooh Ooh ... look falcon replied to my post. So never is never never. Just remember that I didn't go to you ... and you posted ...
"I know it won't matter to you in the least Mr. takeonit but there are plenty of us who have been here for years that employed your strategy and it still hasn't worked. We have been there and done that so your words ring hollow with us. Mannkind will only prosper when they can figure out how to (really) sell Afrezza. In the interim, you're free to keep grabbing those cheap shares despite how naive that sounds to many of us. Just an FYI."
BTW, aren't you the one that said that you didn't have any MNKD shares ... or maybe it was bare minimal?
In any case ... good luck to you and your buds. End of story.
But, that's mytakeonit
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Post by pat on Jun 11, 2020 6:08:10 GMT -5
Buying shares at these prices doesn’t sound hollow or naive to me. And I’ve been in the stock for like 10 years now. Does that mean that I’ve been there and done that too? Do I qualify to be in the old and wise club? You're nearly there, keep going and you'll get it! Man, I really want to be in your club so badly. I hope I get there soon. |
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Post by mymann on Jun 11, 2020 6:36:23 GMT -5
I'm holding on to this bag of poo for 12 years. Did not sell when Sny kicked my bag to the dumpster and did not sell when the stock was manipulated to $6. I must be stupid or stubborn. Can I join the wise all knowing club?
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. Some have locked up their shares and will let things take their natural course. Others continue to respond to detractors. Then there are those who are tortured and cannot book a loss and move on or have booked a loss and hang around to instigate. That is what you're missing 
