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Post by digger on May 7, 2018 8:05:31 GMT -5
Have they said anything about trying to get the black box changed? Again, I don't see how Mannkind can since they effectively proved that there was some serious risk to people with COPD attempting to use afrezza. What would you or they do to change that? MNKD does not need to change that. RAA's are old and lousy. The people with COPD need to use old and lousy. As far as black box labels, GLP-1 thyroid cancer. SGLT2 amputation, although less heart attacks heh. RAA hyperglycemia and hypoglycemia, Dr. Kevorkian. Heart Attack. I agree that "MNKD does not need to change that." If COPDers actually are at risk for a serious side effect, then they need to be ruled out, and they likely don't represent that many patients anyway. Investors tend to get distracted by things like the REMS deal which meant absolutely nothing in my opinion and in what I consider a pseudoimprovement in insurance coverage. In the meantime, for those that believe in the formularylookup website, fiasp has now moved to 24% preferred and "Fiasp FlexTouch U-100 Insulin has Unrestricted Access for 36% of Commercial lives in All Locations" and it hasn't even been on the market six months. To me the focus needs to be on a trial to gain tier 2. Even the BPs kickbacks couldn't block afrezza if it offered data showing a superior performance.
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Post by cretin11 on May 7, 2018 10:56:07 GMT -5
Is "no taksies backsies" found somewhere in the FDA regs? It's quite volumous, so I may have missed it. Also, if I recall correctly, CEO Michael Castagna made comments, shortly after being promoted by the BoD, that past management made a real mess of Afrezza [paraphrased] and that the current management team was working to rectify past mistakes. Have they said anything about trying to get the black box changed? Again, I don't see how Mannkind can since they effectively proved that there was some serious risk to people with COPD attempting to use afrezza. What would you or they do to change that? Why couldn't MNKD keep the "no COPD" part of the black box warning, but simply eliminate the spirometry requirement? The previous pregnancy analogy seems apt. In other words, if you've been diagnosed with COPD then no Afrezza for you, but somebody with normal lung function shouldn't need a useless spirometry test. People with COPD generally know that they have COPD!
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Post by sportsrancho on May 7, 2018 11:39:42 GMT -5
Have they said anything about trying to get the black box changed? Again, I don't see how Mannkind can since they effectively proved that there was some serious risk to people with COPD attempting to use afrezza. What would you or they do to change that? Why couldn't MNKD keep the "no COPD" part of the black box warning, but simply eliminate the spirometry requirement? The previous pregnancy analogy seems apt. In other words, if you've been diagnosed with COPD then no Afrezza for you, but somebody with normal lung function shouldn't need a useless spirometry test. People with COPD generally know that they have COPD! YES!
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Post by drman7 on May 7, 2018 12:35:16 GMT -5
MNKD does not need to change that. RAA's are old and lousy. The people with COPD need to use old and lousy. As far as black box labels, GLP-1 thyroid cancer. SGLT2 amputation, although less heart attacks heh. RAA hyperglycemia and hypoglycemia, Dr. Kevorkian. Heart Attack. I agree that "MNKD does not need to change that." If COPDers actually are at risk for a serious side effect, then they need to be ruled out, and they likely don't represent that many patients anyway. Investors tend to get distracted by things like the REMS deal which meant absolutely nothing in my opinion and in what I consider a pseudoimprovement in insurance coverage. In the meantime, for those that believe in the formularylookup website, fiasp has now moved to 24% preferred and "Fiasp FlexTouch U-100 Insulin has Unrestricted Access for 36% of Commercial lives in All Locations" and it hasn't even been on the market six months. To me the focus needs to be on a trial to gain tier 2. Even the BPs kickbacks couldn't block afrezza if it offered data showing a superior performance. FIASP is a no brainier because it is in the same category of injection/transport. We are talking about inhaled insulin which only one exist in the universe. Keep in mind Mannkind was hoping for Exubera to eliminate the obstacles of access but that did not go well, did it.
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Post by peppy on May 7, 2018 13:52:06 GMT -5
I agree that "MNKD does not need to change that." If COPDers actually are at risk for a serious side effect, then they need to be ruled out, and they likely don't represent that many patients anyway. Investors tend to get distracted by things like the REMS deal which meant absolutely nothing in my opinion and in what I consider a pseudoimprovement in insurance coverage. In the meantime, for those that believe in the formularylookup website, fiasp has now moved to 24% preferred and "Fiasp FlexTouch U-100 Insulin has Unrestricted Access for 36% of Commercial lives in All Locations" and it hasn't even been on the market six months. To me the focus needs to be on a trial to gain tier 2. Even the BPs kickbacks couldn't block afrezza if it offered data showing a superior performance. FIASP is a no brainier because it is in the same category of injection/transport. We are talking about inhaled insulin which only one exist in the universe. Keep in mind Mannkind was hoping for Exubera to eliminate the obstacles of access but that did not go well, did it. I agree, drman7. Fiasp is a no brainer. If you can get a patient to believe Fiasp is any better than the other RAA's; the patient could star singing: "If I only had a brain."
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Post by od on May 7, 2018 14:05:32 GMT -5
Why couldn't MNKD keep the "no COPD" part of the black box warning, but simply eliminate the spirometry requirement? The previous pregnancy analogy seems apt. In other words, if you've been diagnosed with COPD then no Afrezza for you, but somebody with normal lung function shouldn't need a useless spirometry test. People with COPD generally know that they have COPD! YES! Underdiagnosis in COPD: a battle worth fighting The Lancet Published April 4, 2017 First Summary section sentence - "COPD is a chronic disease universally undiagnosed. Findings from several epidemiological investigations have shown that 75% or more of patients with COPD remain undiagnosed, without substantial changes in recent years." www.thelancet.com/journals/lanres/article/PIIS2213-2600(17)30133-9/abstract?code=lancet-site(Only the summary is available without a subscription.)
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Post by goyocafe on May 7, 2018 14:11:15 GMT -5
FIASP is a no brainier because it is in the same category of injection/transport. We are talking about inhaled insulin which only one exist in the universe. Keep in mind Mannkind was hoping for Exubera to eliminate the obstacles of access but that did not go well, did it. I agree, drman7. Fiasp is a no brainer. If you can get a patient to believe Fiasp is any better than the other RAA's; the patient could star singing: "If I only had a brain." So tired of having my intelligence insulted with their shifty use of Hours vs. Minutes. link
If someone could grab the image and put it in this post, that would be much appreciated.
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Post by peppy on May 7, 2018 14:23:31 GMT -5
Underdiagnosis in COPD: a battle worth fighting The Lancet Published April 4, 2017 First Summary section sentence - "COPD is a chronic disease universally undiagnosed. Findings from several epidemiological investigations have shown that 75% or more of patients with COPD remain undiagnosed, without substantial changes in recent years." www.thelancet.com/journals/lanres/article/PIIS2213-2600(17)30133-9/abstract?code=lancet-site(Only the summary is available without a subscription.) COPD is not difficult to diagnose in late stages. Gasping a big clue. Wheezing. Not being able to get from the chair to the bathroom, another clue.
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Post by agedhippie on May 7, 2018 14:40:56 GMT -5
Underdiagnosis in COPD: a battle worth fighting The Lancet Published April 4, 2017 First Summary section sentence - "COPD is a chronic disease universally undiagnosed. Findings from several epidemiological investigations have shown that 75% or more of patients with COPD remain undiagnosed, without substantial changes in recent years." www.thelancet.com/journals/lanres/article/PIIS2213-2600(17)30133-9/abstract?code=lancet-site(Only the summary is available without a subscription.) This was exactly the issue that led to the requirement that for a lung exam. The concern was that while you could avoid people with known COPD the undiagnosed population were at risk.
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Post by peppy on May 7, 2018 14:56:03 GMT -5
Underdiagnosis in COPD: a battle worth fighting The Lancet Published April 4, 2017 First Summary section sentence - "COPD is a chronic disease universally undiagnosed. Findings from several epidemiological investigations have shown that 75% or more of patients with COPD remain undiagnosed, without substantial changes in recent years." www.thelancet.com/journals/lanres/article/PIIS2213-2600(17)30133-9/abstract?code=lancet-site(Only the summary is available without a subscription.) This was exactly the issue that led to the requirement that for a lung exam. The concern was that while you could avoid people with known COPD the undiagnosed population were at risk. I do not mean to fight with you aged. I just disagree that there is that much undiagnosed COPD individuals that meet the non smoking criteria. What Causes COPD Over time, exposure to irritants that damage your lungs and airways can cause chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. The main cause of COPD is smoking, but nonsmokers can get COPD too. Smoking About 85 to 90 percent of all COPD cases are caused by cigarette smoking. When a cigarette burns, it creates more than 7,000 chemicals, many of which are harmful. The toxins in cigarette smoke weaken your lungs' defense against infections, narrow air passages, cause swelling in air tubes and destroy air sacs—all contributing factors for COPD. Your Environment What you breathe every day at work, home and outside can play a role in developing COPD. Long-term exposure to air pollution, secondhand smoke and dust, fumes and chemicals (which are often work-related) can cause COPD. Alpha-1 Deficiency A small number of people have a rare form of COPD called alpha-1 deficiency-related emphysema. This form of COPD is caused by a genetic (inherited) condition that affects the body's ability to produce a protein (Alpha-1) that protects the lungs. www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd/symptoms-causes-risk-factors/what-causes-copd.html=========================================================================================== The lung org missed a cause. Meconium asperation will cause COPD by another name. These people are under 18.
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Post by mnholdem on May 7, 2018 15:03:45 GMT -5
Agedhippie,
"This was exactly the issue that led to the requirement that for a lung exam. The concern was that while you could avoid people with known COPD the undiagnosed population were at risk."
The same could be said for many drugs that, for example, could have dangerous consequences if used with other drugs or diseases (kidney, liver) and yet they do not require the doc to perform additional tests.
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Post by od on May 7, 2018 15:12:11 GMT -5
This was exactly the issue that led to the requirement that for a lung exam. The concern was that while you could avoid people with known COPD the undiagnosed population were at risk. I do not mean to fight with you aged. I just disagree that there is that much undiagnosed COPD individuals that meet the non smoking criteria.
What Causes COPD Over time, exposure to irritants that damage your lungs and airways can cause chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. The main cause of COPD is smoking, but nonsmokers can get COPD too. Smoking About 85 to 90 percent of all COPD cases are caused by cigarette smoking. When a cigarette burns, it creates more than 7,000 chemicals, many of which are harmful. The toxins in cigarette smoke weaken your lungs' defense against infections, narrow air passages, cause swelling in air tubes and destroy air sacs—all contributing factors for COPD. Your Environment What you breathe every day at work, home and outside can play a role in developing COPD. Long-term exposure to air pollution, secondhand smoke and dust, fumes and chemicals (which are often work-related) can cause COPD. Alpha-1 Deficiency A small number of people have a rare form of COPD called alpha-1 deficiency-related emphysema. This form of COPD is caused by a genetic (inherited) condition that affects the body's ability to produce a protein (Alpha-1) that protects the lungs. www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd/symptoms-causes-risk-factors/what-causes-copd.html=========================================================================================== The lung org missed a cause. Meconium asperation will cause COPD by another name. These people are under 18. Funny how objective, well vetted data is paramount when it supports our guts, but not so much when it does not. ( Not targeting you, Peppy.)
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Post by agedhippie on May 7, 2018 15:14:29 GMT -5
The same could be said for many drugs that, for example, could have dangerous consequences if used with other drugs or diseases (kidney, liver) and yet they do not require the doc to perform additional tests. In this case it is because it is directly linked to the black box warning. Aren't kidney and liver disease measured by blood tests (that's a question, I don't know I just thought they were) and so you get the requirement with some drugs for ongoing blood tests as well.
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Post by digger on May 7, 2018 15:21:30 GMT -5
The same could be said for many drugs that, for example, could have dangerous consequences if used with other drugs or diseases (kidney, liver) and yet they do not require the doc to perform additional tests. The label doesn't "require" the doctor to do anything. It's merely a warning: "WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE • Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. • AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. • Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients" If the doctor and the patient see fit to ignore the warning, then that's their right. On the other hand, if the doctor does chose to ignore the warning and something bad happens in consequence, then the doctor faces a malpractice suit.
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Post by peppy on May 7, 2018 15:42:28 GMT -5
The same could be said for many drugs that, for example, could have dangerous consequences if used with other drugs or diseases (kidney, liver) and yet they do not require the doc to perform additional tests. The label doesn't "require" the doctor to do anything. It's merely a warning: "WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE • Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. • AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. • Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients" If the doctor and the patient see fit to ignore the warning, then that's their right. On the other hand, if the doctor does chose to ignore the warning and something bad happens in consequence, then the doctor faces a malpractice suit.You might make a good physician if you never prescribe a drug/medication with a warning. Not sure how you would treat a type one diabetic, all their good drugs have warnings. Humalog Novolog Apidra pi.lilly.com/us/humalog-pen-pi.pdf• Hyper- or Hypoglycemia with Changes in Insulin Regimen: Carry out under close medical supervision and increase frequency of blood glucose monitoring. (5.2) • Hypoglycemia: May be life-threatening. Monitor blood glucoseand increase monitoring frequency with changes to insulin dosage, use of glucose lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness. (5.3, 7, 8.6, 8.7) • Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. Do not transfer HUMALOG U-200 from the HUMALOG KwikPen to a syringe as overdosage and severe hypoglycemia can result. (5.4) • Hypersensitivity Reactions: May be life-threatening. Discontinue HUMALOG, monitor and treat if indicated. (5.5) • Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. (5.6) Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. (5.7) Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Monitor glucose and administer HUMALOG U-100 by subcutaneous injection if pump malfunction occurs. (5.8) -------------------------------ADVERSE REACTIONS------------------------------ Adverse reactions associated with HUMALOG include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. (6.1)
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