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Post by MnkdWASmyRtrmntPlan on Aug 14, 2019 19:14:38 GMT -5
ADA Makes Important Updates to Standards of Care, Adding Time-in-Range and More First, the Standards of Care now include time-in-range goals for people using CGM. This follows their publication at ADA and reflect important progress in the Beyond A1C and Time-in-Range movements. Previously, there was no agreement on what “range” to use, how much time should be spent in that range, and what a meaningful improvement would be. The range used and time-in-range goal should vary based on the person with diabetes (see below). No matter where someone is starting, every 5% improvement in time-in-range – e.g., going from 60% to 65% - is considered meaningful, as that’s one more hour per day. You can read the full time-in-range goals paper here. For a person with type 1 or type 2 diabetes, the goal is to be in the target range (70-180 mg/dl) more than 70% of the time, with less than 4% spent in hypoglycemia (under 70 mg/dl). Some people with diabetes choose to use a tighter range of 70-140 mg/dl, though 70-180 is a good starting point for many. For older or high-risk people with diabetes, the goal is greater than 50% time-in-range, with less than 1% in hypoglycemia. For pregnant women with type 1, the goal is over 70% in the tighter range of 63-140 mg/dl. (Linked to lower risk of newborn complications.) For pregnant women with gestational and type 2 diabetes, the goal is to spend the vast majority of the day in the tighter range of 63-140 mg/dl. diatribe.org/ada-makes-important-updates-standards-care-adding-time-range-and-more?utm_source=diaTribe&utm_campaign=c2ba4f8f66-EMAIL_CAMPAIGN_2019_08_11_02_22&utm_medium=email&utm_term=0_22467a8528-c2ba4f8f66-153166765
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Post by MnkdWASmyRtrmntPlan on Aug 14, 2019 19:15:51 GMT -5
A little support from the ADA. Making TIR Goals official. Every little bit helps.
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Post by peppy on Aug 14, 2019 19:23:54 GMT -5
From Facebook Afrezza group. Anyone want to guess which day I started Afrezza? I’m happy! (And before anyone gets a little judgey about the “before”, I do have my ranges set pretty tight: 70-120 days, & 70-130 nights...) Still getting used to things & still coughing
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Post by sayhey24 on Aug 14, 2019 19:51:50 GMT -5
Good Grief Dave Kendall! "New data on GLP-1 agonist Trulicity’s heart health benefits were added. At this year’s ADA, results from the REWIND trial showed that Trulicity, a once-weekly injectable GLP-1, resulted in a 12% reduced risk of combined non-fatal stroke, non-fatal heart attack, and heart-related death compared to placebo (a “nothing” pill). 2.4% of people taking Trulicity experienced these events, while 2.7 percent of people taking placebo experienced these events. Importantly, the Standards of Care update highlighted that Trulicity’s heart benefits were seen in both people with and without established heart disease. As such, REWIND offers the first evidence that GLP-1 agonists may prevent strokes and heart attacks in people without diagnosed heart disease." Trulicity and not afrezza??? Come on man! No afrezza but rather a drug that has been shown to cause THYROID TUMORS INCLUDING THYROID CANCER www.trulicity.com/benefits-and-side-effects and now its by name in the SOC? afrezza is the one drug which can actually stop the post meal spike and get the PWD back under 140 in 2 hours so they do not incur vascular degeneration. www.diabetesincontrol.com/pancreatic-cancer-sign-rapid-deterioration-of-diabetes-control/
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Post by peppy on Aug 14, 2019 20:05:34 GMT -5
Good Grief Dave Kendall! "New data on GLP-1 agonist Trulicity’s heart health benefits were added. At this year’s ADA, results from the REWIND trial showed that Trulicity, a once-weekly injectable GLP-1, resulted in a 12% reduced risk of combined non-fatal stroke, non-fatal heart attack, and heart-related death compared to placebo (a “nothing” pill). 2.4% of people taking Trulicity experienced these events, while 2.7 percent of people taking placebo experienced these events. Importantly, the Standards of Care update highlighted that Trulicity’s heart benefits were seen in both people with and without established heart disease. As such, REWIND offers the first evidence that GLP-1 agonists may prevent strokes and heart attacks in people without diagnosed heart disease." Trulicity and not afrezza??? Come on man! No afrezza but rather a drug that has been shown to cause THYROID TUMORS INCLUDING THYROID CANCER www.trulicity.com/benefits-and-side-effects and now its by name in the SOC? afrezza is the one drug which can actually stop the post meal spike and get the PWD back under 140 in 2 hours so they do not incur vascular degeneration. www.diabetesincontrol.com/pancreatic-cancer-sign-rapid-deterioration-of-diabetes-control/Reminds me of the SLGT-2. JARDIANCE is the first type 2 diabetes pill proven to go beyond lowering A1C to reduce the risk of cardiovascular (CV) death for adults who have type 2 diabetes and known heart disease.The public doesn't know about end points? Jardiance, love your numbers, miss your legs. Amputations.
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Post by golfeveryday on Aug 14, 2019 20:06:39 GMT -5
Good Grief Dave Kendall! "New data on GLP-1 agonist Trulicity’s heart health benefits were added. At this year’s ADA, results from the REWIND trial showed that Trulicity, a once-weekly injectable GLP-1, resulted in a 12% reduced risk of combined non-fatal stroke, non-fatal heart attack, and heart-related death compared to placebo (a “nothing” pill). 2.4% of people taking Trulicity experienced these events, while 2.7 percent of people taking placebo experienced these events. Importantly, the Standards of Care update highlighted that Trulicity’s heart benefits were seen in both people with and without established heart disease. As such, REWIND offers the first evidence that GLP-1 agonists may prevent strokes and heart attacks in people without diagnosed heart disease." Trulicity and not afrezza??? Come on man! No afrezza but rather a drug that has been shown to cause THYROID TUMORS INCLUDING THYROID CANCER www.trulicity.com/benefits-and-side-effects and now its by name in the SOC? afrezza is the one drug which can actually stop the post meal spike and get the PWD back under 140 in 2 hours so they do not incur vascular degeneration. www.diabetesincontrol.com/pancreatic-cancer-sign-rapid-deterioration-of-diabetes-control/ money talks.
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Post by mango on Aug 15, 2019 11:59:43 GMT -5
Good Grief Dave Kendall! "New data on GLP-1 agonist Trulicity’s heart health benefits were added. At this year’s ADA, results from the REWIND trial showed that Trulicity, a once-weekly injectable GLP-1, resulted in a 12% reduced risk of combined non-fatal stroke, non-fatal heart attack, and heart-related death compared to placebo (a “nothing” pill). 2.4% of people taking Trulicity experienced these events, while 2.7 percent of people taking placebo experienced these events. Importantly, the Standards of Care update highlighted that Trulicity’s heart benefits were seen in both people with and without established heart disease. As such, REWIND offers the first evidence that GLP-1 agonists may prevent strokes and heart attacks in people without diagnosed heart disease." Trulicity and not afrezza??? Come on man! No afrezza but rather a drug that has been shown to cause THYROID TUMORS INCLUDING THYROID CANCER www.trulicity.com/benefits-and-side-effects and now its by name in the SOC? afrezza is the one drug which can actually stop the post meal spike and get the PWD back under 140 in 2 hours so they do not incur vascular degeneration. www.diabetesincontrol.com/pancreatic-cancer-sign-rapid-deterioration-of-diabetes-control/ money talks. This. Under current ADA leadership, the SoC is pay-to-play and is largely under the influence and control by those in the Insulin Cartel and other diabetes BP conglomerates.
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Post by MnkdWASmyRtrmntPlan on Aug 16, 2019 20:05:59 GMT -5
This. Under current ADA leadership, the SoC is pay-to-play and is largely under the influence and control by those in the Insulin Cartel and other diabetes BP conglomerates. I wonder what the cost was of that Rewind study. And, what would it cost MNKD to do a study that would be worthy of putting Afrezza on the SOC. Or, is a large study really even necessary? That was discussed in the past, and some thought it might not be necessary. Or, how much to buy an ADA SOC membership? Dr. Kendell knows who's palms need greased in the ADA, but does the Insulin Cartel also get to vote on it? If so, it will probably never happen. We discussed this a year ago and posters were optimistic back then when Dr. Kendell was freshly hired. His published articles since then have been less than impressive. Seriously, I wonder if SOC will ever happen for Afrezza. And if so, when? Any thoughts?
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Post by agedhippie on Aug 17, 2019 12:13:09 GMT -5
This. Under current ADA leadership, the SoC is pay-to-play and is largely under the influence and control by those in the Insulin Cartel and other diabetes BP conglomerates. I wonder what the cost was of that Rewind study. And, what would it cost MNKD to do a study that would be worthy of putting Afrezza on the SOC. Or, is a large study really even necessary? That was discussed in the past, and some thought it might not be necessary. Or, how much to buy an ADA SOC membership? Dr. Kendell knows who's palms need greased in the ADA, but does the Insulin Cartel also get to vote on it? If so, it will probably never happen. We discussed this a year ago and posters were optimistic back then when Dr. Kendell was freshly hired. His published articles since then have been less than impressive. Seriously, I wonder if SOC will ever happen for Afrezza. And if so, when? Any thoughts? - Nearly 10,000 participants across a lot of countries for eight years? That's going to be hugely expensive. The cost will be spread across that time but even so. - The cost to do a study that gets into the SOC/ That really depends what you want to achieve. If it's get a to be the preferred insulin I reckon you are going to need a big study (300+) over a multi-year period. You would have to prove better outcomes for the Afrezza group vs. the RAA arm. That means a lower number of complications and CV events. To make it a first line treatment; easily more than Mannkind's market cap. - A large study is necessary to move the SoC. The ADA specifies what weighting they attach to what evidence and it would all need to be class A or B. Class E evidence is the lowest weight and includes clinical experience. - There is no such thing as SoC membership. The SoC is produced by a committee ( care.diabetesjournals.org/content/42/Supplement_1/S3) - Any claims have to be supported by evidence. That's the barrier. Eli Lilly can afford to conduct trials like REWIND which are needle moving events, but Mannkind can only afford pilot studies and those go nowhere. It's not that the process is overtly corrupt, it's that proving superiority is expensive because diabetes moves slowly so proving better outcomes inevitably takes time and numbers. Now you are looking at multi-year trials with hundreds of people. That's very difficult for small companies to fund. This is why talk of greasing palms is dumb, it would be irrelevant because of the trial costs. - Dr Kendall cashed in his influence chips when he went to work for Eli Lilly. To the ADA he is just another endo pushing a company's drugs. You are either buy side or sell side and right now he is sell side. He has a good background, but I would expect him to have less influence than people give him credit for. His greatest value is in his knowledge of how the process works - what to publish where for maximum effect, and how to frame results. But this requires him to have results to work with and absent those there is very little he can do. Will the SoC happen for Afrezza? Define happen. Those are my thoughts.
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Post by lennymnkd on Aug 17, 2019 13:16:36 GMT -5
Cgm’s /data app’s don’t mitigate some of the cost ? lessen the length of time to complete a trial.. might not be as bad as everyone thinks ...
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Post by helmut8056 on Aug 17, 2019 14:27:00 GMT -5
Aged: If what you say is true and I totally agree, Afrezza will not become part of the SOC for well over five yrs. from now. Maybe ten! if mnkd can not come up with a different strategy.
Why do you think the mnkd BOD and MC do not want to give VDEX the time of day?
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Post by MnkdWASmyRtrmntPlan on Aug 17, 2019 15:07:44 GMT -5
Aged: If what you say is true and I totally agree, Afrezza will not become part of the SOC for well over five yrs. from now. Maybe ten! if mnkd can not come up with a different strategy. Why do you think the mnkd BOD and MC do not want to give VDEX the time of day? Right, Helmut. If SoC is not in the cards, then what? Because the current route of selling Afrezza is not working. Vdex is the only "think-outside-the-box" solution that is available, and it makes a whole lot of sense. Look, I have been a pro-MC poster since he was hired into Sales. I pinned all my hopes on him, as did many/most other MNKD investors. But, his strategies have not performed with Afrezza sales ... simple and true. It took me awhile to change my thinking about MC, or as I see it "come to my senses". I gave him every benefit of the doubt. I was very annoyed to read posters saying bad things about him. Blasphemy! But, ya know what? His Afrezza sales strategy stinks and he shows no sign of acknowledging that truth or modifying that failed strategy. He is not going to change one iota of his sales strategy, and us shareholders will continue to suffer as a consequence. DTC does more harm than good until he fixes the problems. Too many sales people can also do more harm than good (MC does seem to have possibly acknowledged that by reducing the size of Sales, but that may be more strictly due to financial restrictions than to his realization that it is bad strategy). MC needs to fix the sales problems. SoC would fix those problems immediately, but that does not seem likely to happen anytime soon. So, without Afrezza being in the SoC, there needs to be another method to foster cultivation of new subscribing patients and nurture them to keep them as ongoing patients. Vdex has that solution. I don't know how, but I think that anyway we shareholders can help Vdex to help Afrezza, we should. Obviously, the first way is to cast your vote for your shares on the HFM website if you haven't yet. If you are not onboard, then perhaps you just need to give it more serious thought/consideration. I just don't see any down-side to helping Vdex and I resent MC more than anything for not welcoming their strategy. MC is not too stupid to understand it, I believe he is just too arrogant to admit his failures. And that is costing us shareholders dearly. Go Vdex Go MNKD
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Post by lennymnkd on Aug 17, 2019 15:37:27 GMT -5
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Post by lennymnkd on Aug 17, 2019 15:47:28 GMT -5
The Future Of Clinical Trials: How AI & Big Tech Could Make Drug Development Cheaper, Faster, & More Effective August 7, 2018 Share The Future Of Clinical Trials: How AI & Big Tech Could Make Drug Development Cheaper, Faster, & More Effective on Facebook Share The Future Of Clinical Trials: How AI & Big Tech Could Make Drug Development Cheaper, Faster, & More Effective on Twitter Share The Future Of Clinical Trials: How AI & Big Tech Could Make Drug Development Cheaper, Faster, & More Effective on LinkedIn Share The Future Of Clinical Trials: How AI & Big Tech Could Make Drug Development Cheaper, Faster, & More Effective via Email Artificial Intelligence Digital Health Testing new drugs is a slow, expensive, and manual process. Artificial intelligence has the potential to disrupt every stage of the clinical trials process — from matching eligible patients to studies to monitoring adherence and data collection.
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Post by lennymnkd on Aug 17, 2019 15:48:55 GMT -5
Make VDEX part of it !
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