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Post by peppy on Jun 23, 2018 11:15:17 GMT -5
It was very interesting to me that over the last couple of days how the naysayers have been frantic to downplay the results. The shorts attacked the share price while all of this FUD has been spread about the STAT study being a dud. Thank goodness the medical world doesn’t care about what people on Stocktwits or SA post. What the medical world cares about is honest trial data. What the medical world considers to be significant is different than we might expect. That is why I am grateful that MannKind published the news release explaining that Dr. Kendall believes that the STAT study and the late breaking poster are significant results. Dr. Kendall will be preaching these results everywhere. Good news indeed. Unfortunately it is on your screen, it's tough to wipe your rear end with it, that's the only thing they're useful for. The one question I asked that was consistently passed over.... can you tell me if you know what the statistical significance is regarding the numbers? Please note the following for the carrier pigeon's and you know who you are Dr. Kendall >>> than two bit writers (that is a greater sign btw) as I have stated over and over again.... you can't fix stupid because as they understand and interpret it a statistically significant reduction in hypo risk while being allowed to increase one's (PWD) BG control with Afrezza is not going to be translated into saving lives. Let alone translate into the investment world either. s ayhey24 you have been spot on, no need to waste anymore time trying to educate that which cannot be helped. Enjoy the rest of your weekends!! Quote; you can't fix stupid because as they understand and interpret it a statistically significant reduction in hypo risk while being allowed to increase one's (PWD) BG control with Afrezza is not going to be translated into saving lives.
Reply: Please for give me. After years of reading package inserts, I Question if Big Pharma is actually in the business of saving lives. The life saving I do see in Medicine is acute care, trauma care.
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Post by celo on Jun 23, 2018 11:18:35 GMT -5
GOOOOOOOOOOOOOAAAAAAAAAAALLLLLL!!!!!!!!!! MANNKIND!!!
Mexico is up 1-0. Sorry got a little excited
These are significant results, especially the way they have been presented by Dr. Kendall
Afrezza should be considered standard of care for Diabetes
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Post by babaoriley on Jun 23, 2018 11:23:25 GMT -5
Well, the much awaited STAT study is out and it seems to have done nothing but spawn more disagreements! LOL!
Watch the share price, the script count and any other source of positive cash flow. If you're not an endo yourself (or a "bioendocrinologist" - don't bother looking it up, I just made it up and you all know what I mean), you can get very twisted in these arguments over the STAT study results.
By the way, Bioexec reminded me of the all-star laden MannKind Scientific Advisory Board - wow! That says something very positive. Look, all hope is not lost, perhaps some..., but not as the result recent events (or posts by pguererro, Kastanes and a few others), more by events of the post-approval era in general.
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Post by peppy on Jun 23, 2018 11:48:49 GMT -5
Well, the much awaited STAT study is out and it seems to have done nothing but spawn more disagreements! LOL! Watch the share price, the script count and any other source of positive cash flow. If you're not an endo yourself (or a "bioendocrinologist" - don't bother looking it up, I just made it up and you all know what I mean), you can get very twisted in these arguments over the STAT study results. By the way, Bioexec reminded me of the all-star laden MannKind Scientific Advisory Board - wow! That says something very positive. Look, all hope is not lost, perhaps some..., but not as the result recent events (or posts by pguererro, Kastanes and a few others), more by events of the post-approval era in general. Or, if there is anything to the maybe made up story, that, "It is the label, Stupid" perhaps Afrezza will make some head way with insurance companies. * We do know insurance companies exist to make a profit. It looks like insurance manufacturers rebates may be 30%. (The Art of the Deal) Highlights: Compared to insulin aspart, the per-protocol use of Afrezza (i.e., with supplemental doses 1 and/or 2 hours post-meal): Significantly improved all-day glucose time-in-range by an average of 1.5 hours, or 12% Significantly decreased daytime glucose variability by 17% Significantly reduced the time spent in hypoglycemia (i.e., <70 mg/dl) by 41% or approximately 23 minutes per day Conclusion: The faster action with shorter duration profile of Afrezza when compared to rapid-acting insulin analogs may provide a flexible approach for patients to optimize post-prandial glucose control without increasing risk of hypoglycemia
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Post by mytakeonit on Jun 23, 2018 14:39:56 GMT -5
You mean ... I was right about "last chance to buy MNKD at under $2" WOW !!!
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ADA
Jun 23, 2018 15:10:05 GMT -5
Post by peppy on Jun 23, 2018 15:10:05 GMT -5
sayhey24 I appreciate your input but it would have been informative to include the HbA1c values. When a company doesn't provide pertinent data, I start questioning. I question things also. so if the baseline was 7.7 - 1.2 = 6.5 HbA1c Title: Total and Severe Hypoglycemia is Reduced With Use of Inhaled Technosphere® Insulin (AFREZZA®) Relative to Insulin Aspart in Type 1 Diabetes Presenter: Lawrence Blonde Highlights: Compared to insulin aspart: Use of Afrezza significantly lowers the rate of hypoglycemia in Type 1 diabetes while providing similar or better glycemic control (54.1 events per subject vs. 78.2 events per subject, a reduction of 31%)On average, 26% lower rates of hypoglycemia were observed with Afrezza across the range of HbA1c levels, allowing the same degree of glycemic control with less hypoglycemia than insulin aspart. For example, a patient with an HbA1c of 8.0% on insulin aspart would experience the same rate of hypoglycemia (12.2 events per month) as a patient on Afrezza with an HbA1c of 6.8% (ΔHbA1c = -1.2%)Alternatively, patients with HbA1c of 6.8% on Afrezza would be estimated to experience 4 fewer hypoglycemic events per month than a similar patient on insulin aspart Conclusion: Use of Afrezza in a multi-dose insulin regimen may permit treatment intensification to be achieved with less hypoglycemia. Switching to Afrezza may also benefit patients already at goal by reducing the frequency of hypoglycemia events. See it; (ΔHbA1c = -1.2%) read change in HbA1c - 1.2%
investors.mannkindcorp.com/news-releases/news-release-details/mannkind-presents-positive-afrezzar-clinical-data-stat-and
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Post by peppy on Jun 23, 2018 15:27:01 GMT -5
So the quick wrap up is a 1.2% HbA1c reduction with 31% less hypoglycemia. Did I get that right? I am a poor little baby who has lost my way, bah bah black sheep.
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Post by Deleted on Jun 23, 2018 15:33:34 GMT -5
A1C is a 3 month average metric of glucose control. PPG is a a daily (in the moment) measure of glucose post meal. An HbA1C measurement can be performed anytime with one blood draw. It was the secondary endpoint. Change in HbA1c in one-month treatment [ Time Frame: 4 weeks ] Kas, remember A1C is simply an average glucose level over 90 days. A1C does not speak to the volatility of BG levels and its the volatility that does the long term damage. CGMs will replace the A1C but the CGMs have not been around that long. Today, they are vastly improved and will continue to do so with better accuracy, longer wear times, smaller size and reduced price. As you know, costs are easier to amortize over a larger user base. DXCM has the relationship with Verily (Google) and they are working on a nickel size sensor that will cost around $10. A bit of diabetes diagnostic history for you: Way way way back, there were no diagnostic products to evaluate diabetes so an "expert" would taste urine to determine if glucose was present. Many many years later, products used to determine if glucose was present in urine included Lilly "TesTape" and Ames (Now Bayer) Clinitabs. Problem with testing urine for glucose is that BG levels have to surpass the renal threshold before excess sugar spills into the kidneys and then excreted which is a nice way of saying testing for glucose in urine will tell you many hours after the spill that your BG levels are way out of whack. In the late 70s the first home BG products came to market. With these products, an astute and compliant patient could track and then get some idea where their BG levels were and how volatile they were but even with this, an A1C provided a better info in terms of average BG levels over time. DexCom has done a lot of good work in the CGM market but its not like they got to where they are now overnight. Its taken a lot of starts and stops along with a lot of money. A1C will go the way of the buggy whip. Side note, notice all the ads for pre-diabetes? Part of that is awareness but if your A1C is 5.7 or higher, you are now considered diabetic. The question is, what will the health insurers pay the providers to get patient Doe's A1C below 5.7? Providers now positioning for fee for outcome era which may come sooner than we all realize especially within the diabetes space since its the one disease state with the potential to bankrupt the US healthcare system. Will be interesting to see what the Amazon, JPM and Berkshire Hathaway come up with for their healthcare endeavor. The MD they just brought on board is all about preventative care.
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Post by agedhippie on Jun 23, 2018 17:27:23 GMT -5
Will be interesting to see what the Amazon, JPM and Berkshire Hathaway come up with for their healthcare endeavor. The MD they just brought on board is all about preventative care. His basic tenet is described in this paper - The Cost Conundrum. Fundamentally he believes that we need integrated medical practices like the Mayo Clinic. I am going to write a longer post on this and where I think it goes which I will post elsewhere since it is off-topic for this thread. This is the closing paragraph from that article which is the manifesto: As America struggles to extend health-care coverage while curbing health-care costs, we face a decision that is more important than whether we have a public-insurance option, more important than whether we will have a single-payer system in the long run or a mixture of public and private insurance, as we do now. The decision is whether we are going to reward the leaders who are trying to build a new generation of Mayos and Grand Junctions. If we don’t, McAllen won’t be an outlier. It will be our future.
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ADA
Jun 23, 2018 20:07:05 GMT -5
Post by agedhippie on Jun 23, 2018 20:07:05 GMT -5
I think I can avoid sticking myself with a Dexcom. Here is a screen shot from a month ago, no pump just injections: It's a noisy screen because it has most xdrip's features turned on. My average for the last 24 hours is 131, 87% TIR, standard deviation is 32. What does it all mean? - The dotted blue line in my level - The solid green line is insulin (note the stacking). - The dotted purple line is the predicted future levels ending around 68. I am about to eat so I don't care that it thinks I am going low in this case. - The range is set at 180 (the yellow bar) and 70 (the red bar). - The dotted green line is carbs that I have not yet digested - The two red dots on white are finger stick meter readings The 24 hour graph at the bottom shows a yellow spike around 10am (this is a weekend) when I had a bowl of cereal and a couple of slices of toast and marmalade End result - TIR of 87%. That is why the STAT results do not impress me, I had expected better.
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Post by peppy on Jun 24, 2018 0:17:47 GMT -5
Afrezza, 1.2% HbA1c reduction with 31% less hypoglycemia. www.facebook.com/groups/268385496689037/?ref=bookmarks======================================================================================================== I had my first (in 24 years as a diabetic) time of having my husband call paramedics yesterday when he got home from work and I wasn't responding. He gave me some glucagon gel and honey and I came to a few minutes before EMS arrived and luckily everything ended up being ok! Anyway, because of that happening, he now wants to follow my CGM or however that works... we have never used that before. I have the G5, and use the tandem T slim X2 pump as my receiver. We have Android phones. Is it possible for him to follow me? Or is that only with iPhones? He downloaded Dexcom follow, but I can't figure out what to do from my pump to have him find my Dexcom signal or however this works? Thanks for any insight you can give me!! =================================================================================================================== ==================================================================================================== First time in 33 years I had to call an ambulance for my husband. He is ok now. Insulin reaction. Thank God for Dexcom. Gave him glucagon while he was having a seizure on the floor. He bent the needle and not sure how much he got. But he drank some syrup just before he fell off the bed and seized. By the time the ambulance got here he was responsive. I may not get over this, I am usually so in control, not tonight.
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Post by sportsrancho on Jun 24, 2018 6:33:07 GMT -5
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Post by sayhey24 on Jun 24, 2018 7:42:21 GMT -5
Kastanes - I just saw the press release, see the daytime wording Significantly improved all-day glucose time-in-range by an average of 1.5 hours, or 12% Significantly decreased daytime glucose variability by 17% Significantly reduced the time spent in hypoglycemia (i.e., <70 mg/dl) by 41% or approximately 23 minutes per day Conclusion: The faster action with shorter duration profile of Afrezza when compared to rapid-acting insulin analogs may provide a flexible approach for patients to optimize post-prandial glucose control without increasing risk of hypoglycemia
Let me add the 41% allows the flexibility to adjust the basal and get the better A1c numbers you are looking for. Adjusting baseline was not part of the study. - "A patient with an HbA1c of 8.0% on insulin aspart would experience the same rate of hypoglycemia (12.2 events per month) as a patient on Afrezza with an HbA1c of 6.8% (ΔHbA1c = -1.2%)" I think thats the number you were looking for and its HUGE.
It looks like afrezza just obsoleted the RAAs and its easier to use!
Sayhey, I can actually now follow what you are saying clearly now. This is really great! 🎯 Speaking of obsolete, it appears to me Agedhippie might now be obsolete. 😆 Brother - its been a long road and I am glad what I have been saying for years is now being understood and was demonstrated in an "Official, Peer Reviewed Study". One thing for sure, I am damn glad Dr. Kendall is there, could interrupt the results and present them in plain English and then put out the press release they did.
As far as Aged, we love Aged. While soft bashing afrezza for years, he/she has always been respectful and I for one always like a good challenge. Who is obsoleted are Aged's endos who 3+ years ago said afrezza would make your lungs explode and they are still teaching people the medically incorrect way to adjust their baseline.
Maybe now Aged will give afrezza a go, at least for the corrections. What I would now like to see is an "Official" study showing afrezza's use for corrections. How great would those results be?
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ADA
Jun 24, 2018 9:08:58 GMT -5
Post by mnkdfann on Jun 24, 2018 9:08:58 GMT -5
Brother - its been a long road and I am glad what I have been saying for years is now being understood and was demonstrated in an "Official, Peer Reviewed Study". One thing for sure, I am damn glad Dr. Kendall is there, could interrupt the results and present them in plain English and then put out the press release they did. What makes you think that the study has been peer reviewed? Peer review of an abstract submitted to the ADA is very different from peer reviewing the study itself. (To be fair, I've never attended or presented at the ADA. But I have submitted abstracts and presented at other scientific conferences. In my experience, conference abstracts are typically reviewed only for English, grammar, topic suitability, things like that.) If the study results are as good as being claimed, I do hope they get published in a significant and respected peer reviewed journal soon.
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Post by peppy on Jun 24, 2018 9:49:13 GMT -5
Sayhey, I can actually now follow what you are saying clearly now. This is really great! 🎯 Speaking of obsolete, it appears to me Agedhippie might now be obsolete. 😆 Brother - its been a long road and I am glad what I have been saying for years is now being understood and was demonstrated in an "Official, Peer Reviewed Study". One thing for sure, I am damn glad Dr. Kendall is there, could interrupt the results and present them in plain English and then put out the press release they did.
As far as Aged, we love Aged. While soft bashing afrezza for years, he/she has always been respectful and I for one always like a good challenge. Who is obsoleted are Aged's endos who 3+ years ago said afrezza would make your lungs explode and they are still teaching people the medically incorrect way to adjust their baseline.
Maybe now Aged will give afrezza a go, at least for the corrections. What I would now like to see is an "Official" study showing afrezza's use for corrections. How great would those results be?
I would leave aged alone. Aged is smart enough and knowledgeable enough to make his own decisions. if aged wanted afrezza he would have gotten it already. Aged knows how to stack and when to eat. Me, I am thankful, I do not have the malady. As far as type two, my plan would be to get the fat out of my cells, so insulin could once again have glucose enter my cells. The plan, diet, NO MEAT, NO Diary, NO oil. In this country so far we all get to make our own medical decisions, until we can't. Me, as long as I have consciousness, I do not intend to give my medical decisions to a human being that barely knows me and has 15 mins to determine what pill they can prescribe for their overlords benefit. one more thing, a physician can write a prescription, I do not have to fill it or take it. we get to choose. And aged comes in handy. "Put another log on the fire Cook me up some bacon and some beans And go out to the car and change the tire Wash my socks and sew my old blue jeans" www.youtube.com/watch?v=BWpYQjuJ0u0
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