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Post by derek2 on Mar 4, 2017 12:55:03 GMT -5
That's interesting because my state was the first to sue Big Tobacco in the master settle agreement. Washington state largely funds the life sciences discovery fund still to this day with their settlement money. The article goes into that.
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Post by mango on Mar 4, 2017 12:56:42 GMT -5
Who decides on what class it is? Insurers or the FDA? Does ultra-rapid acting, fast acting and long acting directly infer what will happen to an HbA1c? Going forward since Dexcom is approved for dosing wouldn't they have to have afrezza in the study and wouldn't they need to show FIAsp is non-inferior in a time in range study to afrezza? There are some studies already currently going on with injectable insulins and CGM. Might be Dexcom's.
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Post by careful2invest on Mar 4, 2017 13:03:07 GMT -5
Didn't post the entire content, that is 169 pages. I just posted the section I found most interesting. On purpose. Perfect time for MNKD to differentiate themselves even more in the public eye and media in general by showing that not only were they (MNKD) not a part of it. MNKD can announce that they have lowered the price of AFREZZA. In doing so, MNKD can appear to be the hero humanitarians that not only charge less, but offer an alternative that can actually lower a users A1C at the same time, and oh yea, it's also inhaleable! If MNKD does not try to monopolize on this event, they are truly inept and I made a $200,000.00 plus dollar mistake in my investment. If this does not pan out, I'm going to have to change my screen name. Because clearly, I was not careful enough 2 invest!
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Post by mango on Mar 4, 2017 13:05:32 GMT -5
That's interesting because my state was the first to sue Big Tobacco in the master settle agreement. Washington state largely funds the life sciences discovery fund still to this day with their settlement money. The article goes into that. It seems like the article is bashing the plaintiffs and attorneys, no? Or maybe I am missing something?
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Post by agedhippie on Mar 4, 2017 13:07:50 GMT -5
What do insurers say about injectable insulin hexamers being amyloidogenic and the inhaled insulin monomer being non-amyloidogenic? Afrezza is non-amyloidogenic because it is a monomer. Do insurers distinguish between the two? We don't need trial data for this because it is already scientifically proven. I have no idea what they say on any of this but I can guess. What do insurers say about injectable insulin hexamers being amyloidogenic and the inhaled insulin monomer being non-amyloidogenic?
They ask you to point to where this is listed as a concern in the Standard of Care. Oh it isn't? Thank you and goodnight. Every drug has side effects and that side effect is never going to sway anyone - it's very rare (there are no numbers to the contrary, just supposition), and it is easily mitigated or avoided (don't inject in the same spot all the time - they tell you that on day one).
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Post by mango on Mar 4, 2017 13:11:30 GMT -5
Didn't post the entire content, that is 169 pages. I just posted the section I found most interesting. On purpose. Perfect time for MNKD to differentiate themselves even more in the public eye and media in general by showing that not only were they (MNKD) not a part of it. MNKD can announce that they have lowered the price of AFREZZA. In doing so, MNKD can appear to be the hero humanitarians that not only charge less, but offer an alternative that can actually lower a users A1C at the same time, and oh yea, it's also inhaleable! If MNKD does not try to monopolize on this event, they are truly inept and I made a $200,000.00 plus dollar mistake in my investment. If this does not pan out, I'm going to have to change my screen name. Because clearly, I was not careful enough 2 invest! I feel that if they drastically lower their price in the midst of this that it would be *I can't think of a word I am feeling about it, but almost would be like saying it is already way too high and also they would be setting themselves up for a trap. If they lower it and then need to raise it legitimately, they potentially would face scrutiny. I don't think they need to lower the price. I do think that there could be an opportunity to draw positive attention however, but in what way and what form I have no idea.
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Post by mango on Mar 4, 2017 13:20:47 GMT -5
What do insurers say about injectable insulin hexamers being amyloidogenic and the inhaled insulin monomer being non-amyloidogenic? Afrezza is non-amyloidogenic because it is a monomer. Do insurers distinguish between the two? We don't need trial data for this because it is already scientifically proven. I have no idea what they say on any of this but I can guess. What do insurers say about injectable insulin hexamers being amyloidogenic and the inhaled insulin monomer being non-amyloidogenic? They ask you to point to where this is listed as a concern in the Standard of Care. Oh it isn't? Thank you and goodnight.Every drug has side effects and that side effect is never going to sway anyone - it's very rare (there are no numbers to the contrary, just supposition), and it is easily mitigated or avoided (don't inject in the same spot all the time - they tell you that on day one). That kind of attitude is exactly what is wrong. I personally do not care about the Standard of Care because the current Standard of Care is a complete failure. It is not very rare and that is a naive statement. The studies and case reports all state that it is commonly misdiagnosed as lipohypertrophy because either: 1) Clinicians lack proper awareness and education that the mass they suspect is lipohypertrophy is more than likely an amyloid mass, 2) lack proper pathology equipment and personel to conduct the histology studies 3) patients do not report the mass because they prefer to use that site over others. Insulin hexamers are amyloidogenic and currently there is only one insulin that I know of that is not and that is Afrezza because it is an insulin monomer which is able to avoid becoming an protein amyloid fibril entirely.
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Post by mango on Mar 4, 2017 13:26:25 GMT -5
Without proper research how are we suppose to know whether or not the bacteria people are injecting into them is or is not also contributing to other physiological conditions, such as cerebral amyloidosis? The structure of the injectable insulin protein amyloids remarkably resemble the endogenous insulin protein amyloid fibrils seen in brains of Alzheimer's Disease patients. And the connection involving the parallel prevalence of diabetes and Alzheimer's is frightening.
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Post by sayhey24 on Mar 4, 2017 13:28:33 GMT -5
Going forward since Dexcom is approved for dosing wouldn't they have to have afrezza in the study and wouldn't they need to show FIAsp is non-inferior in a time in range study to afrezza? There are some studies already currently going on with injectable insulins and CGM. Might be Dexcom's. What are the studies for? I would think MNKD could bring their own law suits if they are not included depending on what the studies are for. Nothing can beat monomer human insulin when properly dosed and I would be surprised if they can show non-inferiority.
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Post by mango on Mar 4, 2017 13:32:29 GMT -5
There are some studies already currently going on with injectable insulins and CGM. Might be Dexcom's. What are the studies for? I would think MNKD could bring their own law suits if they are not included depending on what the studies are for. Nothing can beat monomer human insulin when properly dosed and I would be surprised if they can show non-inferiority. Glucose control. Do a search on pubmed and check them out. Not a lot of them though.
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Post by agedhippie on Mar 4, 2017 13:34:57 GMT -5
I have no idea what they say on any of this but I can guess. What do insurers say about injectable insulin hexamers being amyloidogenic and the inhaled insulin monomer being non-amyloidogenic? They ask you to point to where this is listed as a concern in the Standard of Care. Oh it isn't? Thank you and goodnight.Every drug has side effects and that side effect is never going to sway anyone - it's very rare (there are no numbers to the contrary, just supposition), and it is easily mitigated or avoided (don't inject in the same spot all the time - they tell you that on day one). That kind of attitude is exactly what is wrong. I personally do not care about the Standard of Care because the current Standard of Care is a complete failure. It is not very rare and that is a naive statement. The studies and case reports all state that it is commonly misdiagnosed as lipohypertrophy because either: 1) Clinicians lack proper awareness and education that the mass they suspect is lipohypertrophy is more than likely an amyloid mass, 2) lack proper pathology equipment and personel to conduct the histology studies 3) patients do not report the mass because they prefer to use that site over others. Insulin hexamers are amyloidogenic and currently there is only one insulin that I know of that is not and that is Afrezza because it is an insulin monomer which is able to avoid becoming an protein amyloid fibril entirely. You might not care about Standards of Care but the medical profession does, and in this instance their opinion is the only opinion that matters. I have not seen anywhere a hard number from studies giving the count of people with this issue. I have seen lots of assumptions and theories, but no hard numbers. I know you think this is the silver bullet, but as someone on the receiving end of this stuff I assure you it isn't - doctor catch things like escalating insulin needs because they can be caused by some serious and non-diabetes related conditions and those ones need treating.
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Post by agedhippie on Mar 4, 2017 13:36:26 GMT -5
There are some studies already currently going on with injectable insulins and CGM. Might be Dexcom's. What are the studies for? I would think MNKD could bring their own law suits if they are not included depending on what the studies are for. Nothing can beat monomer human insulin when properly dosed and I would be surprised if they can show non-inferiority. Think those are the Dexcom G6 trials. They need to prove non-inferiority to the G4/5 sensor.
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Post by agedhippie on Mar 4, 2017 13:41:04 GMT -5
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Post by slugworth008 on Mar 4, 2017 13:51:51 GMT -5
I politely ask the moderators to allow this thread to remain in All About MannKind because it is important for everyone to be able to see this information that they otherwise might not. The Federal Class Action lawsuit against Sanofi, Novo Nordisk and Eli Lilly was filed on 1/30/2017 on charges of colluding in insulin price fixing, among other things. The web of corruption that runs among these three companies is an intricate one. This thread is dedicated to the discussion on the Class Action filed against Sanofi, Novo Nordisk and Eli Lilly.... It would be really nice to see this all over the mainstream news !!! And if MNKD could somehow take advantage of this...IMO
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Post by mango on Mar 4, 2017 13:54:34 GMT -5
That kind of attitude is exactly what is wrong. I personally do not care about the Standard of Care because the current Standard of Care is a complete failure. It is not very rare and that is a naive statement. The studies and case reports all state that it is commonly misdiagnosed as lipohypertrophy because either: 1) Clinicians lack proper awareness and education that the mass they suspect is lipohypertrophy is more than likely an amyloid mass, 2) lack proper pathology equipment and personel to conduct the histology studies 3) patients do not report the mass because they prefer to use that site over others. Insulin hexamers are amyloidogenic and currently there is only one insulin that I know of that is not and that is Afrezza because it is an insulin monomer which is able to avoid becoming an protein amyloid fibril entirely. You might not care about Standards of Care but the medical profession does, and in this instance their opinion is the only opinion that matters. I have not seen anywhere a hard number from studies giving the count of people with this issue. I have seen lots of assumptions and theories, but no hard numbers. I know you think this is the silver bullet, but as someone on the receiving end of this stuff I assure you it isn't - doctor catch things like escalating insulin needs because they can be caused by some serious and non-diabetes related conditions and those ones need treating. It is a fact that injectable insulins are amyloidogenic. Insulin-derived localized amyloidosis often mimics lipohypertrophy, and differentiating between the two in clinic cannot be reasonably done without proper pathology study, thus a referral to a dermatologist is warranted in such a case. Which is a lot of cases. Since you are a Standard of Care advocate, then you should have no problem with improving on the current Standard of Care. Injectable insulins should be required to carry black box warnings stating the insulin is amyloidogenic and can form amyloid masses at repeated injection sites, and perhaps this would raise awareness for patients to rotate their sites more often, and also for clinicians to become more aware of the existence of this important complication of insulin therapy in order for them to become more proactive in examining the injection sites for signs and symptoms. Raising awareness on this important risk factor of an already established fact would perhaps result in clinicians referring patients to a dermatologist when clinically indicated, because it has already been scientifically established that injected insulin-derived localized amyloidosis and lipohypertrophy can be indistinguishable from one another clinically because the amyloidosis can mimic lipohypertrophy, not the other way around, therefore a clinician will never know what the mass is without proper evaluation and histology studies. End of story.
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