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Post by suebeeee1 on Dec 15, 2015 17:37:12 GMT -5
Thank you for that - science aside you just PINPOINTED why Afrezza will succeed - Prick or breathe? Adherence. If 30pct of the diabetic population opts to feel like crap rather than prick themselves with a needle... you do the math. It appears you are trying to say those who use Afrezza feel like crap. Perhaps I am reading you wrong and if so, my apology. Are you using Afrezza? Have you spoken with real live people who use it? If so, you would know that it doesn't cause you to "feel like crap". It doesn't even cause the mild transient cough for most people. The people I know using it ALL rave about it!. It works and you eliminate many sticks and pricks every day! That, my friend, leaves one feeling VERY good! |
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Post by hankscorpio7 on Dec 15, 2015 17:56:10 GMT -5
Thanks stalk my profile again in couple of months and maybe I will have it figured out Great exchange. No seriously- you have the pink female symbol in the corner of your tag. Sorry if you are genuine and going through issues. |
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Post by dreamboatcruise on Dec 15, 2015 18:15:03 GMT -5
Are you over weight? Maybe thats why you find it bizarre and are more accepting of it not being a big deal. Yes, I think it is hypocritical for someone who is over weight to talk about their concerns for their lungs when they have no control over what they consume. Its clear as day that he states SNY could drop MNKD and than transitions into the Dr's comments. The Dr also states the same thing in a stronger negative light. I am wrong that it was just the blogger. I have no idea how many beverages he consumes a day but I am pretty positive no Dr is going to be ok with the type of beer he is drinking. Most of his pictures are of what looks to be very high caloric (ton of sugar) thick beer. I bet those beers wreck havoc on his blood sugar. How do I know this? Because I would never waste my daily calories and drink a beer that is equalivlent to a meal. This is how you get fat. I am 210lbs 6'3 and am probably about 16% body fat (google that if you need a visual). I have been active my whole life. In the past five years I haven't missed going to the gym for more then about 30 days. For the past three years I have trained MMA and spare (light contact) with amatuer fighters half my age once a week. I measure my macro nutrients down to the precise amount of grams of protein, carbs and fat measured by my tdee (total daily energy expenditure). I also do yoga once a week to stay flexible to prevent injuries as I get older. So I am pretty confident in my ability to decipher what is and isn't healthy as I am almost 40 and have the body of a man in his 20's and its because of my discipline through my diet. If you need cholesterol levels also let me know. BMI 19.8 here... at 49 years old. Enjoy good beers. Here is nutritional information from one of my favorites... Samuel Smith Nut Brown Ale... looks and tastes very rich. Nutritional info: Serving Size - 12 oz. (355 ml). Calories: 180; Total Fat 0 g (0% Daily Value); Sodium 40 mg (2% DV); Total Carbohydrates 13 g (4% DV); Protein 1 g (2% DV). (Percent Daily Values are based on a 2,000 calorie daily diet.) I stay active. Don't count calories, but never had problems overeating. Love cooking, whether it be a leg of lamb or a vegan dinner. We do seem to have very different approaches to staying healthy, though I certainly don't distrust those that have different approaches. |
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Post by dreamboatcruise on Dec 15, 2015 18:18:29 GMT -5
Thank you for that - science aside you just PINPOINTED why Afrezza will succeed - Prick or breathe? Adherence. If 30pct of the diabetic population opts to feel like crap rather than prick themselves with a needle... you do the math. It appears you are trying to say those who use Afrezza feel like crap. Perhaps I am reading you wrong and if so, my apology. Are you using Afrezza? Have you spoken with real live people who use it? If so, you would know that it doesn't cause you to "feel like crap". It doesn't even cause the mild transient cough for most people. The people I know using it ALL rave about it!. It works and you eliminate many sticks and pricks every day! That, my friend, leaves one feeling VERY good! I think he meant that those that have not yet had opportunity to get Afrezza may inadequately treat their diabetes because of not wanting to start on an injection or being less than fully compliant with its use. |
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Post by Deleted on Dec 15, 2015 20:24:53 GMT -5
you posted your gender as a female. then you posted that you are a 40 year old male who said you look like you are in your 20's. I'm not making this up. No one else created your profile except for you. I don't stalk. I research. As it has been expressed to us here by moderators, "it is best to read the poster's previous posts before replying to them" was good advice. Deal with it. If you are a male pretending to be a female at least get a tin foil hat and make believe all you want. The criteria for your credibility is determined by your words; not mine. Nope as I said it was probably just a typo when I signed up. I am sure you know what a typo is? Its similar to the mistake you made today posting George Rhos article that had nothing to do with MNKD and then blamed it on terrorist threats shutting down schools in your area? Carry on and reply thinking I am male or female. |
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Post by Deleted on Dec 15, 2015 20:28:36 GMT -5
Thanks stalk my profile again in couple of months and maybe I will have it figured out Great exchange. No seriously- you have the pink female symbol in the corner of your tag. Sorry if you are genuine and going through issues. It was pretty funny. I had no idea until he mentioned it. I am going to leave it up though. |
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Post by Deleted on Dec 15, 2015 20:35:28 GMT -5
Are you over weight? Maybe thats why you find it bizarre and are more accepting of it not being a big deal. Yes, I think it is hypocritical for someone who is over weight to talk about their concerns for their lungs when they have no control over what they consume. Its clear as day that he states SNY could drop MNKD and than transitions into the Dr's comments. The Dr also states the same thing in a stronger negative light. I am wrong that it was just the blogger. I have no idea how many beverages he consumes a day but I am pretty positive no Dr is going to be ok with the type of beer he is drinking. Most of his pictures are of what looks to be very high caloric (ton of sugar) thick beer. I bet those beers wreck havoc on his blood sugar. How do I know this? Because I would never waste my daily calories and drink a beer that is equalivlent to a meal. This is how you get fat. I am 210lbs 6'3 and am probably about 16% body fat (google that if you need a visual). I have been active my whole life. In the past five years I haven't missed going to the gym for more then about 30 days. For the past three years I have trained MMA and spare (light contact) with amatuer fighters half my age once a week. I measure my macro nutrients down to the precise amount of grams of protein, carbs and fat measured by my tdee (total daily energy expenditure). I also do yoga once a week to stay flexible to prevent injuries as I get older. So I am pretty confident in my ability to decipher what is and isn't healthy as I am almost 40 and have the body of a man in his 20's and its because of my discipline through my diet. If you need cholesterol levels also let me know. BMI 19.8 here... at 49 years old. Enjoy good beers. Here is nutritional information from one of my favorites... Samuel Smith Nut Brown Ale... looks and tastes very rich. Nutritional info: Serving Size - 12 oz. (355 ml). Calories: 180; Total Fat 0 g (0% Daily Value); Sodium 40 mg (2% DV); Total Carbohydrates 13 g (4% DV); Protein 1 g (2% DV). (Percent Daily Values are based on a 2,000 calorie daily diet.) I stay active. Don't count calories, but never had problems overeating. Love cooking, whether it be a leg of lamb or a vegan dinner. We do seem to have very different approaches to staying healthy, though I certainly don't distrust those that have different approaches. Those macros for the beer are not bad at all. If I drink I will have red wine with dinner occasionally. Alcohol is just counter productive for my life style. |
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Post by hankscorpio7 on Dec 15, 2015 20:40:08 GMT -5
Great exchange. No seriously- you have the pink female symbol in the corner of your tag. Sorry if you are genuine and going through issues. It was pretty funny. I had no idea until he mentioned it. I am going to leave it up though. Haha.. Why not? I was reading your other post about being 6'3", 210lbs, 16% with your tag saying female and I was thinking Briene(GoT) is on this board? We hit the big time. But, you're a dude... |
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Post by bill on Dec 15, 2015 20:40:55 GMT -5
Thanks stalk my profile again in couple of months and maybe I will have it figured out No stalking of profiles required. The pink or blue icons are just below and to the right of everyone's picture or icon. Can't miss it every time you post  . |
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Post by Deleted on Dec 15, 2015 20:47:45 GMT -5
It was pretty funny. I had no idea until he mentioned it. I am going to leave it up though. Haha.. Why not? I was reading your other post about being 6'3", 210lbs, 16% with your tag saying female and I was thinking Briene(GoT) is on this board? We hit the big time. But, you're a dude... You ever see Briene not dressed like Briene. She is not bad looking. Sorry yea I am a dude. Twig and berries over here. |
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Post by Deleted on Dec 15, 2015 20:48:22 GMT -5
Thanks stalk my profile again in couple of months and maybe I will have it figured out No stalking of profiles required. The pink or blue icons are just below and to the right of everyone's picture or icon. Can't miss it every time you post . I honestly never noticed until just now. I can be the resident Bruce Jenner!!! |
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Post by mnholdem on Dec 15, 2015 21:24:20 GMT -5
Thank you for that - science aside you just PINPOINTED why Afrezza will succeed - Prick or breathe? Adherence. If 30pct of the diabetic population opts to feel like crap rather than prick themselves with a needle... you do the math. It appears you are trying to say those who use Afrezza feel like crap. Perhaps I am reading you wrong and if so, my apology. Are you using Afrezza? Have you spoken with real live people who use it? If so, you would know that it doesn't cause you to "feel like crap". It doesn't even cause the mild transient cough for most people. The people I know using it ALL rave about it!. It works and you eliminate many sticks and pricks every day! That, my friend, leaves one feeling VERY good! I think you may be misinterpreting figglebird's statement. Another way to word it is this way: if 30% of the population would rather spend their days feeling like crap than to have to stick themselves with a needle, that indicates that a LOT of diabetics hate the needles or trying to figure out carb counts, timing, etc. Do the math and figure out how many of those 30% might be willing to try inhaling instead of injections. It's more likely that converts would adhere to the treatment regiment for their disease. That's how I read figglebird's comment. |
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Post by mbracket1234 on Dec 15, 2015 22:08:36 GMT -5
Agreed, that is what he meant. There is a low-hanging fruit of a market that is HUGE...
Everyone is missing the boat on the reality of where we are at. We are going to hit 1000 TRx in a couple of weeks. I don't think anyone gets how absolutely impressive that number is given the low MD numbers that have been targeted and all the other well-known obstacles to getting a script. 1K is simply a huge number. Just wait till the barriers are lowered and marketing/ads start in earnest. You are talking 20K per week in a year - at minimum... Basically, every script has been a hard-won battle to this point. And yet the numbers are there and are growing... To me its the greatest no-brainer in the history of mankind. Oh wait, that is securing a loan from Quicken...
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Post by peppy on Dec 16, 2015 19:43:22 GMT -5
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Post by tommix321 on Dec 22, 2015 13:14:36 GMT -5
"Users report...." Therein lies a problem. To really compare, you need some sort of well documented lifestyle/therapy history before and after starting afrezza. More importantly for afrezza, there needs to be solid clinical documentation to show insurance companies that patients in general are getting consistent improved results and that those results are in some fashion due to afrezza. This sort of documentation invariably requires a large and prolonged trial. I can't find anywhere that Sanofi has indicated whether they plan on any other trials other than those mandated by the FDA. MNKD has discussed label improvement trials as something SNY plans. So they are being led to believe it is SNY intention. Also, as noted today in this thread, the Afrezza medical professional advisory committee is apparently being led to believe that is the case... as it sure seems they are implying it isn't merely a non-inferior safety study being planned. I don't see why the trial would need to be particularly large or prolonged. Unlike a safety study, it is not looking for a rare event. A safety study needs thousands of patients in order to statistically tease out whether the are changes in the infrequent occurrence rate of something like cancer. If the occurrence rate for better blood sugar control is so infrequent as to need thousands, it would also be meaningless. Likewise, something like lower post meal spikes and better average glucose without increased dangerous hypos could be demonstrated with a CGM with a trial lasting 2-3 months... or maybe 4-5 if A1c readings desired. Your previous comment about patients likely being able to achieve the same control with traditional RAA/basal mix seems to be in total opposition to what many users are saying. I'm not a diabetes specialist but have taken control theory in engineering curriculum and it certainly makes total sense to me that have an RAA with a time constant that doesn't match what one wants to eat would pose far more problems than Afrezza that in some circumstances may have too brief action. Granted if a patient were willing to always eat a meal to match RAA's long tail, they might be able to simplify their life... but they also would likely pack on pounds to their health detriment as they would be needing to always plan for a fat laden meal that takes hours to digest and generates enough blood sugar for the body's cells (many of them fat cells) to feast on for hours. RAA's simply present trade offs... put up with higher post meal spikes and subsequent A1c, or deal with the fact that the RAA tail doesn't match the digestion rate of a healthy diet. Sorry I didn't reply to you earlier, but I only just noticed that you had responded to me. "...the trial would need to be particularly large or prolonged." Have you taken statistics? It would be easier to understand an explanation if you have. The trial would have to be designed so as to prove that any superiority that was found could not be credited to simple variability within the population. When you see "p<0.05," what that is saying is that there is less than a 5% chance that the difference in means between the control group and the experimental group is due to variability within the population. To begin, you have to look at the bell curve of whatever item you are trying to prove superior. Take, for example, A1C: Bell curves for a1cNote that for the normal population the curve is very narrow -- that indicates very low variability which means it's easy to detect a difference due to a treatment if one exists. On the other hand, for the undiagnosed diabetes group, the main part of the curve is relatively wide and it has that annoying long tail streaming off into the 15 region. I couldn't find a curve for diabetics being treated with RAA, but given the number of factors that come into play, it is reasonable to assume that treated diabetics will likely also have a relatively wide curve as well. Now, if you imagine your RAA control curve is like the undiagnosed group above, when the experiment is over and you draw your experimental (afrezza) curve on that same graph, the tail of the afrezza curve must not overlap the control curve by more than 5% of the area under the curve in order to claim a significant difference. IF the afrezza graph is similarly wide and has that annoying tail shooting off to the right, then it will likely be difficult to demonstrate a significant difference from RAA with statistics. Under "real life" circumstances, about the only option you have for "narrowing" the graphs is by increasing the number of subjects, and there are methods that allow a statistician to estimate the number of subjects needed to detect a difference given the standard error of the item in question. No doubt this is the reason Sanofi chose 3,270 as the number of patients felt needed to prove toujeo is better than lantus. As for "lower post meal spikes and better average glucose without increased dangerous hypos could be demonstrated with a CGM with a trial lasting 2-3 months," what matters most is what impresses the insurance companies most. You would have to ask them whether they would accept your criteria. For the toujeo study, the primary outcome measure is: "Proportion of patients with individualized HbA1c target attainment per HEDIS criteria (<8% if age ≥65 years or with defined comorbidities or otherwise <7%) at 6 months without documented symptomatic (BG ≤70 mg/dL) hypoglycemia." That is a one year trial. Presuming Sanofi chose those criteria with insurance reimbursement in mind, I would presume that they would look at afrezza the same way. That trial was estimated to last two years, so I would anticipate a similar time frame for afrezza. "Your previous comment about patients likely being able to achieve the same control with traditional RAA/basal mix seems to be in total opposition...what users are saying." I would point out that you are hearing the voices of a select group of people who have been successful. They do not necessarily represent the results of a controlled study. I can't disagree with the rest of your paragraph. My point was that control can be achieved with any currently available insulin product as long as the diabetic is willing to work at it. Some insulins require more work than others, but if the diabetic is determined, then it can be done. |
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