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Post by ktim on Apr 25, 2019 13:55:28 GMT -5
This data and presentation is exactly what Dr. Kendall promised he would deliver. Is it flashy or market moving? Nope. However, the consistent flow of sound, well researched papers presented at events like this help continue to build a solid foundation for doctor and insurance acceptance. Dr. Kendall knows what it takes to establish Afrezza to the medical community. So glad to see him do it again. ANY other bio company would be up 20% on this news...MM’s have complete control Look up some of the other companies presenting posters at this conference and let me know if you find even one that popped anything close to 20% when their poster was announced.
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Post by bones1026 on Apr 25, 2019 14:09:49 GMT -5
ANY other bio company would be up 20% on this news...MM’s have complete control Look up some of the other companies presenting posters at this conference and let me know if you find even one that popped anything close to 20% when their poster was announced. Do their posters state they have studies to validate that their FDA label should read “Ultra Rapid” insulin?
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Post by ktim on Apr 25, 2019 14:35:34 GMT -5
Look up some of the other companies presenting posters at this conference and let me know if you find even one that popped anything close to 20% when their poster was announced. Do their posters state they have studies to validate that their FDA label should read “Ultra Rapid” insulin? We've had the pk/pd profiles from way before the initial approval decision by FDA. It's been known all along Afrezza was significantly faster in and out. For whatever reason FDA decided that a unique adjective wasn't appropriate (assuming MNKD asked for one, which I believe they did). Many companies present quite positive results in posters for there own class of drugs. They obviously aren't going to present bad data. Your assertion was "any other company", so presumably you weren't simply referring to Novo, the only other company with a faster insulin. I'm simply calling it out as nonsense that you are asserting a made up notion that a poster presentation such as this would so wildly move share price ordinarily. Anything important enough to move share price by 20%, such as announcing a cure for some type of cancer, would be in the main presentation at a major conference, not a poster session at a smaller one. I would still challenge you to find anything every at any conference presented in a poster session that popped a company's share price 20%.
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Post by hellodolly on Apr 25, 2019 14:43:10 GMT -5
Objective : To compare the metabolic responses to 2 insulins demonstrating distinctly different pharmacokinetic profiles, Technosphere® Insulin (TI) inhalation powder and subcutaneous insulin lispro (LIS). TI inhalation powder undergoes ultra-rapid absorption with a correspondingly fast onset and quick rise to peak action with a short duration of effect. LIS is absorbed more slowly with a longer time to peak action and longer duration of glucose-lowering effect.
Methods : Twelve patients with type 2 diabetes underwent 2 mixed-meal tolerance tests after receiving LIS 10 U (n=12) or TI 16 or 24 units (n=6 per dose) in random order in a cross-over design. Endogenous glucose production (EGP) rate and glucose absorption (Ra) and disposal rates (Rd) were derived from tracer data.
Results : With TI, the maximum Rd and maximum EGP suppression occurred 30 to 45 minutes after the start of the meal and coincided with the maximum Ra from the meal. With LIS, pharmacodynamic effects peaked after the maximum Ra.
Discussion : The mean PPG curves for the 3 treatments demonstrated that TI achieves nearly constant glucose concentrations for 90 minutes after the start of the meal, while PPG significantly rises within the first 30 minutes after administration of LIS. The mean PPG excursion of the group receiving TI 24 units did not exceed 10 mg/dL during the first 90 minutes. In contrast, the PPG excursion after LIS 10 U required less than 20 minutes to reach 10 mg/dL. A dose of TI 16 units controlled PPG excursions below 10 mg/dL for more than 45 minutes. Differences from the LIS-PPG curve were statistically significant from 30 to 60 minutes at the low dose of TI and from 45 to 105 minutes at the higher dose of TI. The tight control of early PPG results from the agreement in timing of TI’s insulin-induced glucose demand and glucose absorption from a mixed meal. The duration of PPG control is dose dependent. Consistent with its short duration of effect, PPG started to rise approximately 120 minutes after dosing, but TI’s rapid clearance suggests a small supplemental dose may be taken at that time to extend control with little risk of late postprandial hypoglycemia.
Conclusion : These studies confirm that TI, with its well-timed, insulin-mediated glucose disposal and suppression of EGP, can handle early absorption of glucose during mixed meals.
SOURCE:https://am.aace.com/searchbyposterbucket.asp?pfp=PosterBucket3&f=PosterTrack&bm=3&sddo=0
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Post by mytakeonit on Apr 25, 2019 15:11:35 GMT -5
I wanted to do some buys ... but E*Trade said that my bank account doesn't exist.
But, that's mytakeonit
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Post by sportsrancho on Apr 25, 2019 16:54:51 GMT -5
I wanted to do some buys ... but E*Trade said that my bank account doesn't exist. But, that's mytakeonit If I were to tweet that out on Twitter for you they’ll have it fixed within minutes😉
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Post by mytakeonit on Apr 25, 2019 17:44:31 GMT -5
And all those Twitter people would be spending my $$$ and saying "Tweet".
But, that's mytakeonit
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Post by peppy on Apr 25, 2019 18:38:41 GMT -5
What Afrezza needs is insurance coverage. Thinking about what people have said in the past, "Endocrinologists are slow to change" Let me fix that for us. Endocrinologists know the gig. The gig is the standards of care and the insurance companies. They work between the lines. I was listening to Elizabeth Warren last night. She said, paraphrasing, "Big Pharma stops small Pharma......" I thought, look at that, she knows. She knows big Pharma has the money to do all the studies for the label. Small Pharma does not have all the money for all the studies. (SGLT2. Love your numbers, miss your legs isn't included in the Pharma commercial. Rather, it is heart smart to send glucose out the kidney. This is crazy chit backed up by some study?) What a convoluted system we have that physicians can not order a non inferior insulin, because it can not receive insurance coverage with out disturbing the profits of the insurance companies that are supposed to be working for US. it is sad, that medicine is making type 1 diabetes use an inferior insulin and say it is not. Rapid ACTING SUBQ insulin Afrezza There are only a few people on this board that have witnessed the information sabotage here. I ask you. Some physician tells you there has been cancer found. Are you going to do the chemo?knowing what you know now?
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Post by mango on Apr 25, 2019 18:41:22 GMT -5
I have always been impressed by MannKind's posters, definitely among the best out there. Veins of Gold kinda stuff for sure.
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Post by mango on Apr 25, 2019 18:47:23 GMT -5
What Afrezza needs is insurance coverage. Thinking about what people have said in the past, "Endocrinologists are slow to change" Let me fix that for us. Endocrinologists know the gig. The gig is the standards of care and the insurance companies. They work between the lines. I was listening to Elizabeth Warren last nights said, paraphrasing, "Big Pharma stops small Pharma......" I thought, look at that, she knows. She knows big Pharma has the money to do all the studies for the label. Small Pharma does not have all the money for all the studies. What a convoluted system we have that physicians can not order a non inferior insulin, because it can not receive insurance coverage with out disturbing the profits of the insurance companies that are supposed to be working for US. it is sad, that medicine is making type 1 diabetes use an inferior insulin.
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Post by agedhippie on Apr 25, 2019 19:52:17 GMT -5
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Post by peppy on Apr 25, 2019 19:58:43 GMT -5
I think we should post this. "How you doing?"
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Post by agedhippie on Apr 25, 2019 20:19:59 GMT -5
I think we should post this. "How you doing?" Lol. Truth is most peoples CGM graphs look nothing like that. Actually this is why I don't like the current crop of manufacturers devices and apps. Looking at that graph I could guess a likely scenario. They wanted to go to sleep around 10:30pm but were dropping so they ate something (that brief upturn) and went to sleep. However they had far more insulin onboard that they thought so it quickly swallowed the spike and they kept dropping. The alarm goes off and they panic ("what happened? I ate and I am still dropping, arghhh") and completely over treated - cue the rising curve at about 3:00am that pushes them up to that peak. Now they are bout 400 (22 on the CGM) and have to beat it back down contending with insulin resistance from the high as well. They over do it... and so on. All of this could be avoided by using a CGM with decent software. If they were using an app like Spike or xDrip+ it would show the insulin remaining and graph the predicted glucose level so they would know there was a problem and could deal with it before you went to sleep.
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Post by cjm18 on Apr 25, 2019 20:29:58 GMT -5
To move the needle these type of studies need to change the label, get the ultrafast designation, or impact the standard of care. Hoping Dr. Kendall will provide some info relating 1 or 2 soon. He did say they were planning small trial to get the ultra fast designation. They must have scrapped that or delayed it.
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Post by mannmade on Apr 25, 2019 20:38:15 GMT -5
I think we should post this. "How you doing?" Lol. Truth is most peoples CGM graphs look nothing like that. Actually this is why I don't like the current crop of manufacturers devices and apps. Looking at that graph I could guess a likely scenario. They wanted to go to sleep around 10:30pm but were dropping so they ate something (that brief upturn) and went to sleep. However they had far more insulin onboard that they thought so it quickly swallowed the spike and they kept dropping. The alarm goes off and they panic ("what happened? I ate and I am still dropping, arghhh") and completely over treated - cue the rising curve at about 3:00am that pushes them up to that peak. Now they are bout 400 (22 on the CGM) and have to beat it back down contending with insulin resistance from the high as well. They over do it... and so on. All of this could be avoided by using a CGM with decent software. If they were using an app like Spike or xDrip+ it would show the insulin remaining and graph the predicted glucose level so they would know there was a problem and could deal with it before you went to sleep. They also could have avoided by taking afrezza...
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