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Post by goyocafe on Jul 3, 2018 5:30:10 GMT -5
Now that the STAT results are out, I wonder what the next steps are? How often does the ADA convene and review new findings? We know they can make changes to the living standards of care at more frequent intervals now, but what will they require to compel them to do so? Will Dr Kendall’s comments about a moral and ethical obligation to make Afrezza a more favorable option to other insulins resonate with the members of the ADA? Could a change to the SOC happen in a flash?
It’s one thing to think endos left the ADA convention impressed with the STAT results, but if the ADA makes a move, that could turn this ship in the right direction very quickly.
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Post by xoxoxoxo on Jul 3, 2018 5:35:30 GMT -5
Nothing will change until you gets hundreds of thousands of people using afrezza and happy about it. These types of doctors are very risk averse and wouldn’t recommend a change until there was overwhelming evidence.
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Post by matt on Jul 3, 2018 10:46:53 GMT -5
No manufacturer can compel the ADA to do anything. STAT, while helpful, did not exactly provide earth shattering results as the conclusion was pretty much predetermined. Physicians look to "levels of evidence" when making treatment recommendations and if you are not familiar with the levels, in the United States these are:
Level I: Evidence obtained from at least one properly designed randomized controlled trial.
Level II-1: Evidence obtained from well-designed controlled trials without randomization.
Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.
Level II-3: Evidence obtained from multiple time series designs with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees
Some countries have additional levels of evidence but the framework is similar.
STAT was not a controlled trial since only the patients on the Afrezza arm were allowed to adjust their insulin dose following the meal in response to the CGM. That makes it a Level III study at best, and that is the least persuasive form of evidence. If MNKD wants to move the needle they need to sponsor a large randomized mullti-center controlled trial where all patients are given the opportunity to adjust their insulin dose after seeing the results from a glucose meter. If the results from that study demonstrate that time in range is statistically better with Afrezza than other RAI products, or if Afrezza has similar time in range but with fewer hypoglycemic events that require a visit to the ER, then they will have a compelling argument.
The two big problems with STAT are these:
1. The cohort sizes were too small. In order to get the necessary statistical power, a proper study would require 300-500 patients over a longer period such as 90-180 days.
2. Allowing the Afrezza patients to adjust their dosing in response to the CGM results, not once but twice, stacked the deck against the comparator. Both arms must be allowed to adjust the dose after seeing the initial results for the trial to be credible.
Some will say that patients on injectable insulin will avoid multiple needle sticks or that they will have too many severe hypo events, but that is precisely what the trial needs to show. If so many needle sticks is a major issue then patients on RAI will not be in range as long, and if the second bolus causes hypo events that should show up in the data as well. Opinions are not Level I evidence; data from a well-designed trial is evidence. Level I evidence, preferably with some parallel economic evidence showing that Afrezza is cost effective, is what it will take.
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Post by goyocafe on Jul 3, 2018 12:14:56 GMT -5
No manufacturer can compel the ADA to do anything. STAT, while helpful, did not exactly provide earth shattering results as the conclusion was pretty much predetermined. Physicians look to "levels of evidence" when making treatment recommendations and if you are not familiar with the levels, in the United States these are: Level I: Evidence obtained from at least one properly designed randomized controlled trial. Level II-1: Evidence obtained from well-designed controlled trials without randomization. Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group. Level II-3: Evidence obtained from multiple time series designs with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence. Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees Some countries have additional levels of evidence but the framework is similar. STAT was not a controlled trial since only the patients on the Afrezza arm were allowed to adjust their insulin dose following the meal in response to the CGM. That makes it a Level III study at best, and that is the least persuasive form of evidence. If MNKD wants to move the needle they need to sponsor a large randomized mullti-center controlled trial where all patients are given the opportunity to adjust their insulin dose after seeing the results from a glucose meter. If the results from that study demonstrate that time in range is statistically better with Afrezza than other RAI products, or if Afrezza has similar time in range but with fewer hypoglycemic events that require a visit to the ER, then they will have a compelling argument. The two big problems with STAT are these: 1. The cohort sizes were too small. In order to get the necessary statistical power, a proper study would require 300-500 patients over a longer period such as 90-180 days. 2. Allowing the Afrezza patients to adjust their dosing in response to the CGM results, not once but twice, stacked the deck against the comparator. Both arms must be allowed to adjust the dose after seeing the initial results for the trial to be credible. Some will say that patients on injectable insulin will avoid multiple needle sticks or that they will have too many severe hypo events, but that is precisely what the trial needs to show. If so many needle sticks is a major issue then patients on RAI will not be in range as long, and if the second bolus causes hypo events that should show up in the data as well. Opinions are not Level I evidence; data from a well-designed trial is evidence. Level I evidence, preferably with some parallel economic evidence showing that Afrezza is cost effective, is what it will take. Bummer!😟 |
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Post by awesomo on Jul 3, 2018 12:39:20 GMT -5
Thanks for the realistic take matt. I've seen enough of the "STAT results are the greatest thing since sliced bread" posts.
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Post by joeypotsandpans on Jul 3, 2018 12:50:42 GMT -5
No manufacturer can compel the ADA to do anything. STAT, while helpful, did not exactly provide earth shattering results as the conclusion was pretty much predetermined. Physicians look to "levels of evidence" when making treatment recommendations and if you are not familiar with the levels, in the United States these are: Level I: Evidence obtained from at least one properly designed randomized controlled trial. Level II-1: Evidence obtained from well-designed controlled trials without randomization. Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group. Level II-3: Evidence obtained from multiple time series designs with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence. Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees Some countries have additional levels of evidence but the framework is similar. STAT was not a controlled trial since only the patients on the Afrezza arm were allowed to adjust their insulin dose following the meal in response to the CGM. That makes it a Level III study at best, and that is the least persuasive form of evidence. If MNKD wants to move the needle they need to sponsor a large randomized mullti-center controlled trial where all patients are given the opportunity to adjust their insulin dose after seeing the results from a glucose meter. If the results from that study demonstrate that time in range is statistically better with Afrezza than other RAI products, or if Afrezza has similar time in range but with fewer hypoglycemic events that require a visit to the ER, then they will have a compelling argument. The two big problems with STAT are these: 1. The cohort sizes were too small. In order to get the necessary statistical power, a proper study would require 300-500 patients over a longer period such as 90-180 days. 2. Allowing the Afrezza patients to adjust their dosing in response to the CGM results, not once but twice, stacked the deck against the comparator. Both arms must be allowed to adjust the dose after seeing the initial results for the trial to be credible. Some will say that patients on injectable insulin will avoid multiple needle sticks or that they will have too many severe hypo events, but that is precisely what the trial needs to show. If so many needle sticks is a major issue then patients on RAI will not be in range as long, and if the second bolus causes hypo events that should show up in the data as well. Opinions are not Level I evidence; data from a well-designed trial is evidence. Level I evidence, preferably with some parallel economic evidence showing that Afrezza is cost effective, is what it will take. Again, common sense, I will take my lead from the qualified chief medical officer who was a former head of the ADA and chief global scientist for one of the leading BP's in the space rather than someone that trolls the boards with ulterior motives and recommends via direct messaging to people to sell their shares  thank you. |
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Post by babaoriley on Jul 3, 2018 12:52:48 GMT -5
Thanks for the realistic take matt. I've seen enough of the "STAT results are the greatest thing since sliced bread" posts. Exactly what is so great about sliced bread? Is it that tough to slice yourself?
Awesomo, you are a great wingman for Matt, et al. |
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Post by nylefty on Jul 3, 2018 13:29:41 GMT -5
Hey,at least Proboards Matt is no longer preparing us for bankruptcy (or telling us that the sales force is costing us $10 million a month).
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Post by cjm18 on Jul 3, 2018 13:30:41 GMT -5
No manufacturer can compel the ADA to do anything. STAT, while helpful, did not exactly provide earth shattering results as the conclusion was pretty much predetermined. Physicians look to "levels of evidence" when making treatment recommendations and if you are not familiar with the levels, in the United States these are: Level I: Evidence obtained from at least one properly designed randomized controlled trial. Level II-1: Evidence obtained from well-designed controlled trials without randomization. Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group. Level II-3: Evidence obtained from multiple time series designs with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence. Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees Some countries have additional levels of evidence but the framework is similar. STAT was not a controlled trial since only the patients on the Afrezza arm were allowed to adjust their insulin dose following the meal in response to the CGM. That makes it a Level III study at best, and that is the least persuasive form of evidence. If MNKD wants to move the needle they need to sponsor a large randomized mullti-center controlled trial where all patients are given the opportunity to adjust their insulin dose after seeing the results from a glucose meter. If the results from that study demonstrate that time in range is statistically better with Afrezza than other RAI products, or if Afrezza has similar time in range but with fewer hypoglycemic events that require a visit to the ER, then they will have a compelling argument. The two big problems with STAT are these: 1. The cohort sizes were too small. In order to get the necessary statistical power, a proper study would require 300-500 patients over a longer period such as 90-180 days. 2. Allowing the Afrezza patients to adjust their dosing in response to the CGM results, not once but twice, stacked the deck against the comparator. Both arms must be allowed to adjust the dose after seeing the initial results for the trial to be credible. Some will say that patients on injectable insulin will avoid multiple needle sticks or that they will have too many severe hypo events, but that is precisely what the trial needs to show. If so many needle sticks is a major issue then patients on RAI will not be in range as long, and if the second bolus causes hypo events that should show up in the data as well. Opinions are not Level I evidence; data from a well-designed trial is evidence. Level I evidence, preferably with some parallel economic evidence showing that Afrezza is cost effective, is what it will take. Again, common sense, I will take my lead from the qualified chief medical officer who was a former head of the ADA and chief global scientist for one of the leading BP's in the space rather than someone that trolls the boards with ulterior motives and recommends via direct messaging to people to sell their shares thank you. Same CMO that said he would buy shares and hasn’t? He also downplayed the stat study when asked at the investors meeting. |
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Post by awesomo on Jul 3, 2018 13:34:18 GMT -5
Thanks for the realistic take matt. I've seen enough of the "STAT results are the greatest thing since sliced bread" posts. Exactly what is so great about sliced bread? Is it that tough to slice yourself?
Awesomo, you are a great wingman for Matt, et al. Nope, just a longterm shareholder dealing with yet another disappointment. |
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Post by bioexec25 on Jul 3, 2018 13:47:06 GMT -5
Joey, You stated what many believe but don’t always say regarding these passive aggressive posts. Thanks for calling it out!! Negative or short views in a very knowledgeable process wrapper are helpful for technical understanding but not for wisdom or conviction.
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Post by compound26 on Jul 3, 2018 13:56:12 GMT -5
Hey,at least Proboards Matt is no longer preparing us for bankruptcy (or telling us that the sales force is costing us $10 million a month). Yes, Proboards Matt knew for a fact that back in 2016 Mannkind's meager contract sales force cost Mannkind $10 million a month. Proboards Matt also observed that Mannkind was burning about $20 million a month in 2016 even though Mannkind was talking about a $10 million/month burning rate. Here is Matt's number crunching. mnkd.proboards.com/post/75017 |
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Post by rockstarrick on Jul 3, 2018 13:57:57 GMT -5
Exactly what is so great about sliced bread? Is it that tough to slice yourself?
Awesomo, you are a great wingman for Matt, et al. Nope, just a longterm shareholder dealing with yet another disappointment. You set yourself up for it, it’s not reasonable to expect Wallstreet to react to data such as the STAT study. First the Medical community must react, if/when that happens, then Wallstreet should follow. It’s not going to happen overnight,, or maybe not at all,, but I doubt that. Kendall has let his opinion of Afrezza and Time in Range vs Hb1ac be known, MNKD has a National Advertising Campaign implemented, which is what shareholders have been screaming for for years. (“Start the commercials !!!”) And now we wait, but I think it’s safe to say there is an honest effort being made to make Afrezza more popular with PWD and the Medical Community. I wish you, me, and everybody the best of luck with our decision to invest in MNKD Have a great Holiday weekend. ✌🏻🇺🇸😎 |
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Post by gareaudan on Jul 3, 2018 14:17:23 GMT -5
Again, common sense, I will take my lead from the qualified chief medical officer who was a former head of the ADA and chief global scientist for one of the leading BP's in the space rather than someone that trolls the boards with ulterior motives and recommends via direct messaging to people to sell their shares thank you. Same CMO that said he would buy shares and hasn’t? He also downplayed the stat study when asked at the investors meeting. first, i think he said he would buy shares as soon as he could, not when you wanted him to buy. Second, he didnt downplayed the stat study, he said exactly what it was, a small study of only 60 persons who showed very interresting things. Why so much negativity about Dr Kendall? He has only been great since his arrival with mnkd. |
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Post by peppy on Jul 3, 2018 14:32:41 GMT -5
What will the ADA do.
More contact with health care insurers. Price per share will go up when Afrezza cracks united health.
Meta analysis.
Advertising. "Afrezza reduces your risk of severe hypoglycemia by 31%."
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thank you.
