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Post by mango on Jun 5, 2018 9:28:05 GMT -5
Actually it's 317 late-breaking posters, not 100. That's about 15% of the total posters. There tend to be a lot of late-breaking posters because people are slack about filing dates, not that I ever was... (where is a tunelessly whistling emote...) Kendall can only work so fast. It sounded to be, that the work was done off the STAT, as well as any other data he found and is going to present. It got the impression, the hypoglycemia work also involved the Scientific advisory board the has been formed. www.mannkindcorp.com/about-us/scientific-advisory-board/How many past presidents/chief medical officers of the American Diabetes Association does it take to know how to change the standards of care? I think 50% or something of them has to agree first?
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Post by peppy on Jun 5, 2018 9:31:51 GMT -5
HbA1c is a proxy for average glucose and does not reflect glucose homeostasis. It is subject to significant limitations and drawbacks. That's why TIR is the primary endpoint with STAT, it more accurately assesses glucose homeostasis. I am not arguing for HbA1c over TIR. I am simply saying that the counter-argument to the lower hypos measure will be that there was also a worse HbA1c which is why there reduced hypos. My point is that this is not a slam dunk which is why it is a poster. In my world, the HbA1c is a screening tool to get people on medication. I do not believe it to be a good tool.
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Post by dh4mizzou on Jun 5, 2018 9:49:04 GMT -5
Aged, are you saying that Afrezza results in higher (worse) A1Cs than "injectable" insulins? If so where did you get that from?
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Post by mango on Jun 5, 2018 9:59:04 GMT -5
HbA1c is a proxy for average glucose and does not reflect glucose homeostasis. It is subject to significant limitations and drawbacks. That's why TIR is the primary endpoint with STAT, it more accurately assesses glucose homeostasis. I am not arguing for HbA1c over TIR. I am simply saying that the counter-argument to the lower hypos measure will be that there was also a worse HbA1c which is why there reduced hypos. My point is that this is not a slam dunk which is why it is a poster. Counter argument by whom? There are 10 diabetes experts with MannKind, many of them world-renowned, and all of whom do not froth in out-dated and medically incorrect practices—hence why they are in support of Afrezza becoming the Standard of Care. The counter argument to HbA1c is it does not reflect glucose homeostasis. TIR is the most accurate reflection of glucose homeostasis.
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Post by mnholdem on Jun 5, 2018 9:59:10 GMT -5
The counter to that is going to be that it was achieved at the cost of a worse HbA1c outcome and that if the RAA arm had similarly underperformed their hypo rate would also be lower. That said I don't see a poster having a lot of impact, they need to get this published in a journal. 100% agree with getting the data published, but I don't see how you can assume a worse HbA1c outcome unless you see all the data. It's quite possible that the analysis filtered out doses taken too soon before mealtime, for example. We'll all have to wait to see what they Kendall and the SAB did with the data, I think.
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Post by mango on Jun 5, 2018 10:06:15 GMT -5
Frequent plunges in blood glucose levels, including those resulting in hypoglycemia, particularly postprandial hypoglycemia, has a significant effect in reducing HbA1c. I can't say that hypoglycemia is a good thing, but I will admit that it does greatly contribute to lowering HbA1c.
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Post by agedhippie on Jun 5, 2018 10:45:36 GMT -5
The counter to that is going to be that it was achieved at the cost of a worse HbA1c outcome and that if the RAA arm had similarly underperformed their hypo rate would also be lower. That said I don't see a poster having a lot of impact, they need to get this published in a journal. 100% agree with getting the data published, but I don't see how you can assume a worse HbA1c outcome unless you see all the data. It's quite possible that the analysis filtered out doses taken too soon before mealtime, for example. We'll all have to wait to see what they Kendall and the SAB did with the data, I think. I had been working on the idea that the hypo data was based off the phase 3 Type 1 study (171) although I could be the STAT study. I would have thought STAT was too small to get a robust reading off. There is a story to be told there, and as we both agree it needs to be published.
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Post by agedhippie on Jun 5, 2018 11:05:22 GMT -5
Aged, are you saying that Afrezza results in higher (worse) A1Cs than "injectable" insulins? If so where did you get that from? The Phase 3 trial for Type 1 diabetics, aka the 171 trial ( link). From the Mannkind press release for the trial: Over the 24-week treatment period of this study, A1c levels decreased comparably in the AFREZZA-Gen2 group (-0.21%) and the insulin aspart group (-0.40%). The reduction from Afrezza is virtually half the reduction from Novolog.
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Post by mango on Jun 5, 2018 11:20:01 GMT -5
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Post by agedhippie on Jun 5, 2018 11:27:10 GMT -5
I am not arguing for HbA1c over TIR. I am simply saying that the counter-argument to the lower hypos measure will be that there was also a worse HbA1c which is why there reduced hypos. My point is that this is not a slam dunk which is why it is a poster. Counter argument by whom? There are 10 diabetes experts with MannKind, many of them world-renowned, and all of whom do not froth in out-dated and medically incorrect practices—hence why they are in support of Afrezza becoming the Standard of Care. The counter argument to HbA1c is it does not reflect glucose homeostasis. TIR is the most accurate reflection of glucose homeostasis. Counter argument from whom? From any endo who is looking to justify a move. TIR may well be a better measure, but right now the one everyone uses is HbA1c. Mannkind has hired a Scientific Advisory Board so you have to think that their view at least roughly aligns with the TIR as a measure or they wouldn't have been hired. I am genuinely curious as to whether there is any public record of their views - in a bored moment I might go and have a look and ignore this report I am meant to be writing...
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Post by stockwhisperer on Jun 5, 2018 11:48:31 GMT -5
stockwhisperer ... there are a lot of hypotheticals. Listing them isn't an argument that they are likely. It's not tearing apart what you say, as you're basically just saying that things are possible. True enough. I too believe Mike is doing a fine job. Still likely we will have some significant further dilution based on what we can see from finances, where share price is currently and failed attempts to monetize IP despite concerted effort over past year with hired guns to do so. The company was in far worse shape before he became CEO, as he has alluded to. So even where we realistically are today (not wishful versions) is still good work on Mike's part. Isn’t anything speculated via a list or otherwise hypothetical. It’s all in how it is perceived... some people may think something is very likely to happen based on what they think is going on (at least as much as they know of it). Others may have their own opinions and differ completely. Until it actually happens, it is all a guess. Some may think their predictions are more educated than others but the reality is, no matter how much they are argued or debated, they are still opinions of scenarios that may or may not play out. In any case, you may very well be right about more dilution but I am just, personally, not concerned about it. As mentioned before, dilution is not always a bad thing. I believe that MNKD is heading in the right direction and that based on catalysts, there are more positive outcomes in store than some folks might realize.
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Post by mango on Jun 5, 2018 12:48:54 GMT -5
Counter argument by whom? There are 10 diabetes experts with MannKind, many of them world-renowned, and all of whom do not froth in out-dated and medically incorrect practices—hence why they are in support of Afrezza becoming the Standard of Care. The counter argument to HbA1c is it does not reflect glucose homeostasis. TIR is the most accurate reflection of glucose homeostasis. Counter argument from whom? From any endo who is looking to justify a move. TIR may well be a better measure, but right now the one everyone uses is HbA1c. Mannkind has hired a Scientific Advisory Board so you have to think that their view at least roughly aligns with the TIR as a measure or they wouldn't have been hired. I am genuinely curious as to whether there is any public record of their views - in a bored moment I might go and have a look and ignore this report I am meant to be writing... Satish K. Garg, MD is on the MannKind Scientific Advisory Board and he was also the investigator who initiated the STAT study, and TIR is the primary endpoint. That is public record.
Satish K. Garg, MD-Professor of Medicine and Pediatrics
-Garg Endowed Chairs & Director Adult Program -Barbara Davis Center for Diabetes, University of Colorado Denver -Editor-in-Chief, Diabetes Technology & Therapeutics
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Post by dh4mizzou on Jun 5, 2018 13:26:25 GMT -5
Aged, are you saying that Afrezza results in higher (worse) A1Cs than "injectable" insulins? If so where did you get that from? The Phase 3 trial for Type 1 diabetics, aka the 171 trial ( link). From the Mannkind press release for the trial: Over the 24-week treatment period of this study, A1c levels decreased comparably in the AFREZZA-Gen2 group (-0.21%) and the insulin aspart group (-0.40%). The reduction from Afrezza is virtually half the reduction from Novolog.
Fine. Now I realize we're talking about anecdotal evidence but you're telling me that the people who have posted via social media about their A1C dropping to non-diabetic levels would be even better off using Novolog? Or is it that all of those folks are T2 and that is the difference?
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Post by agedhippie on Jun 5, 2018 14:00:35 GMT -5
The Phase 3 trial for Type 1 diabetics, aka the 171 trial ( link). From the Mannkind press release for the trial: Over the 24-week treatment period of this study, A1c levels decreased comparably in the AFREZZA-Gen2 group (-0.21%) and the insulin aspart group (-0.40%). The reduction from Afrezza is virtually half the reduction from Novolog.
Fine. Now I realize we're talking about anecdotal evidence but you're telling me that the people who have posted via social media about their A1C dropping to non-diabetic levels would be even better off using Novolog? Or is it that all of those folks are T2 and that is the difference?
I am not telling you that at all. Afrezza works well for the people on social media, but that is both a very small and a self-selecting group which makes their conclusions interesting but not actionable. The flip side to the social media group is buried in the renewal rate which would seem to indicate a lot of people for whom Afrezza is not working. I feel that the social media group is probably predominantly Type 1. At root there is an idea that diabetes is deterministic - if I do X I will get Y, and that is repeatable. Doctors are particularly susceptible to this and it's a long standing gripe among diabetics. If your numbers don't line up with what is expected then you cannot be following instruction, or are making things up. I had an interesting conversation with an endo from Mt Sinai who was honest enough to confess that he used to think like that as well until his wife got gestational diabetes and he saw how random things could get.
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Post by dreamboatcruise on Jun 5, 2018 14:09:49 GMT -5
The counter to that is going to be that it was achieved at the cost of a worse HbA1c outcome and that if the RAA arm had similarly underperformed their hypo rate would also be lower. That said I don't see a poster having a lot of impact, they need to get this published in a journal. 100% agree with getting the data published, but I don't see how you can assume a worse HbA1c outcome unless you see all the data. It's quite possible that the analysis filtered out doses taken too soon before mealtime, for example. We'll all have to wait to see what they Kendall and the SAB did with the data, I think. Yes, wait and see. I'm very curious about the "adjustment" that is referenced. In general, however, retrospectively massaging data to present an outcome isn't viewed nearly as highly in medical world as prospective outcome measures built into the study design at the start... if indeed what you are suggesting is the type of "adjustment" being done.
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