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Post by rockstarrick on Jul 29, 2018 19:02:24 GMT -5
I challenge you to find one comment, “embarrassment of riches”, “stay tuned”, “position of strength” , that was made by Al Mann. Al never said anything other than “take care of the Patients and the Shareprice will take care of itself” Al never mislead anybody !! He put his money where his mouth was, and fought for what is most likely, one of the most significant advancements in care, that those living with Diabetes will ever see. Its one thing to sit on a stock message board and vent about the shareprice of Mannkind, but to just barf out bullshit statements such as this, make you appear either either stupid, or dishonest. If you’re going to put false words in somebody’s mouth, at least make it someone who can defend against the BS. 🤬 Maybe Al wasn't the one who said that. My mistake, hey listen I make mistakes. I thought he did. Anyways, look, I believe in Afrezza as much as anyone here. Not happy with the companies' performance. It's that simple. No need to play message board barbarian. Let's talk why management can't execute. No need to play message board barbarian  Now I challenge you to dig through my posting history, (other than this thread), and find any barbaric comments, or replies to comments. You are probably talking to one of the least confrontational members of this board. Read your comment that inspired my response, your comment was either made hastily without knowing what you were saying was true, or it was a flat out lie. I’m thinking it was an honest mistake, but regardless, my reply was accurate. Sorry for the delivery, but when replying to someone who puts so much emphasis on the truth, I felt I should let you know just how far from the truth you were. “Truth hurts sometimes, but I think it's healthy to know it” Right ?? I sincerely apologize for any unintended disrespect. ✌🏻 Read more: mnkd.proboards.com/thread/10272/reality-situation?page=6#ixzz5MgqyMwwy |
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Post by sayhey24 on Jul 29, 2018 19:14:14 GMT -5
I would agree. If the market sees Dr. Kendall deliver on the T1 inclusion there is little reason they should not think he will also be able to change the current T2 standard. However, the T2 hill is much steeper but the rewards significantly larger. Having t come before GLP-1 use would be huge and take the Trulicity market. Having it in its proper place which would be as step 1 with or without metformin and you are easily looking at 10x the IPO price. I really need to read the standard of care better. For some reason I only read the recommendations for Type 1 which pushes RAA. The section on insulin therapy for Type 1 already has a paragraph on Afrezza including this: Rapid-acting inhaled insulin used before meals in patients with type 1 diabetes was shown to be noninferior when compared with aspart insulin for A1C lowering, with less hypoglycemia observed with inhaled insulin therapy.Likewise the Type 2 section has a sub-section on Afrezza as well. I think my original premise that this would be trivial to do for Type 1 might be wrong. It may be a bit harder than I had thought because Afrezza underperformed HbA1c reduction against RAA in the 171 trial. I still think it is possible though. The important thing is that inhaled insulin is already in the standard of care both for Type 1 and Type 2. Getting prandial insulin moved out of it's current sequence is going to be extremely difficult though and will take a big trial to make it happen - there is just to much trial evidence on the GLP-1 side as it stands. I think what Dr Kendall knows, and Mannkind previously never understood, is that you have to have a steady stream of evidence level A or B trials to fortify your position in the medical world. Aged - keep reading and what does the standard say about afrezza? In not so many words its junk when compared to RAAs because RAAs reduce A1c better.
I agree with you as I too think making the needed changes are a huge effort. On the other hand Dr. Kendall thinks its the easiest job he has ever had. Given the scientific board he easily put together I have to give him the benefit of the doubt. At this point the market is not.
As far as the GLP-1s go, they are a disaster. There is some discussion that this class of drugs is so unsafe the entire class will be pulled. There is a suit in the 9th circuit which should be ruled on soon concerning Januvia, Byetta and Victoza over pancreatic cancer and pancreatitis. Here is a good summary on it - www.drugwatch.com/januvia/litigation/As bad as these are Trulicity may be even worse, if thats possible. It was approved on 5 small studies.
It already comes with an FDA ‘black box’ warning about its risks of medullary thyroid cancer and other thyroid tumours. It was approved on the basis of just five small clinical trials (less than is usual for this kind of drug). The FDA has required the Eli Lilly to carry out five ‘post-marketing studies’, including an assessment of cardiovascular risks in people with type 2 diabetes as there is concern it may cause heart attacks too.
And, the FDA approved last August to have the label add additional warnings about the 15 people who died from anaphylactic reactions, anaphylaxis, and angioedema. Thats on top of the other adverse events, including gastroenteritis Escherichia coli, adenocarcinoma pancreas, pancreatic carcinoma metastatic, diabetic ketoacidosis, and pancreatic carcinoma.
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Post by jmkopp on Jul 29, 2018 20:35:09 GMT -5
Correct, it has nothing to do with current management. Those words are from Al Mann himself. I challenge you to find one comment, “embarrassment of riches”, “stay tuned”, “position of strength” , that was made by Al Mann. Al never said anything other than “take care of the Patients and the Shareprice will take care of itself” Al never mislead anybody !! He put his money where his mouth was, and fought for what is most likely, one of the most significant advancements in care, that those living with Diabetes will ever see. Its one thing to sit on a stock message board and vent about the shareprice of Mannkind, but to just barf out bullshit statements such as this, make you appear either either stupid, or dishonest. If you’re going to put false words in somebody’s mouth, at least make it someone who can defend against the BS. 🤬 If you have been here as long as I have which I think you have, Then you should remeber Al Mann saying he thought this would be the biggest selling drug of all time. In spite of the share price the last 6 years, I still believe him. |
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Post by agedhippie on Jul 29, 2018 21:07:31 GMT -5
I really need to read the standard of care better. For some reason I only read the recommendations for Type 1 which pushes RAA. The section on insulin therapy for Type 1 already has a paragraph on Afrezza including this: Rapid-acting inhaled insulin used before meals in patients with type 1 diabetes was shown to be noninferior when compared with aspart insulin for A1C lowering, with less hypoglycemia observed with inhaled insulin therapy.Likewise the Type 2 section has a sub-section on Afrezza as well. I think my original premise that this would be trivial to do for Type 1 might be wrong. It may be a bit harder than I had thought because Afrezza underperformed HbA1c reduction against RAA in the 171 trial. I still think it is possible though. The important thing is that inhaled insulin is already in the standard of care both for Type 1 and Type 2. Getting prandial insulin moved out of it's current sequence is going to be extremely difficult though and will take a big trial to make it happen - there is just to much trial evidence on the GLP-1 side as it stands. I think what Dr Kendall knows, and Mannkind previously never understood, is that you have to have a steady stream of evidence level A or B trials to fortify your position in the medical world. Aged - keep reading and what does the standard say about afrezza? In not so many words its junk when compared to RAAs because RAAs reduce A1c better.
I agree with you as I too think making the needed changes are a huge effort. On the other hand Dr. Kendall thinks its the easiest job he has ever had. Given the scientific board he easily put together I have to give him the benefit of the doubt. At this point the market is not.
As far as the GLP-1s go, they are a disaster. There is some discussion that this class of drugs is so unsafe the entire class will be pulled. There is a suit in the 9th circuit which should be ruled on soon concerning Januvia, Byetta and Victoza over pancreatic cancer and pancreatitis. Here is a good summary on it - www.drugwatch.com/januvia/litigation/As bad as these are Trulicity may be even worse, if thats possible. It was approved on 5 small studies.
It already comes with an FDA ‘black box’ warning about its risks of medullary thyroid cancer and other thyroid tumours. It was approved on the basis of just five small clinical trials (less than is usual for this kind of drug). The FDA has required the Eli Lilly to carry out five ‘post-marketing studies’, including an assessment of cardiovascular risks in people with type 2 diabetes as there is concern it may cause heart attacks too.
And, the FDA approved last August to have the label add additional warnings about the 15 people who died from anaphylactic reactions, anaphylaxis, and angioedema. Thats on top of the other adverse events, including gastroenteritis Escherichia coli, adenocarcinoma pancreas, pancreatic carcinoma metastatic, diabetic ketoacidosis, and pancreatic carcinoma.
Januvia is a DPP-4, the others are GLP-1 though. Why are they mixing up the classes? There is zero chance of GLP-1 being pulled from the market. On the contrary you are going to see the ADA/EASD Consensus Statement in October push it to the front of Type 2 treatment directly behind or alongside metformin. If you have CVD then SGLT-2 will preempt it. That aside the LEADER trial killed the CV risk stone dead with this in the conclusion of the study - In the time-to-event analysis, the rate of the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke among patients with type 2 diabetes mellitus was lower with liraglutide than with placebo. The lawsuit dies because the LEADER trial found no evidence to support the claims. LEADER was a 9,830 person long term trial (Category A evidence) to look at all cause mortality, and CVD in users of GLP-1. The findings were that there are no CVD risks, and there is no provable cancer risk, that is it's not proven, and it's not cleared - courtesy of the FDA Oncology group evaluation of the LEADER results. All drugs carry risk, the question is whether the benefit outweighs the risk. In the first instance that is the FDA's call, and subsequently the doctor's call. There is no sign the FDA or doctors are going to change their position of GLP-1, and LEADER cements that. Remember Afrezza still has to conduct " A 5-year, randomized, controlled trial in 8,000-10,000 patients with type
2 diabetes to assess the serious potential risk of pulmonary malignancy with
Afrezza use" and has a lung cancer risk right there on the label. I doubt anyone here expects that to go badly, same applies to most drugs. |
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Post by sportsrancho on Jul 29, 2018 21:07:54 GMT -5
I challenge you to find one comment, “embarrassment of riches”, “stay tuned”, “position of strength” , that was made by Al Mann. Al never said anything other than “take care of the Patients and the Shareprice will take care of itself” Al never mislead anybody !! He put his money where his mouth was, and fought for what is most likely, one of the most significant advancements in care, that those living with Diabetes will ever see. Its one thing to sit on a stock message board and vent about the shareprice of Mannkind, but to just barf out bullshit statements such as this, make you appear either either stupid, or dishonest. If you’re going to put false words in somebody’s mouth, at least make it someone who can defend against the BS. 🤬 If you have been here as long as I have which I think you have, Then you should remeber Al Mann saying he thought this would be the biggest selling drug of all time. In spite of the share price the last 6 years, I still believe him. And then he joked we might buy Merck:-) |
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Post by rockstarrick on Jul 29, 2018 21:15:34 GMT -5
I challenge you to find one comment, “embarrassment of riches”, “stay tuned”, “position of strength” , that was made by Al Mann. Al never said anything other than “take care of the Patients and the Shareprice will take care of itself” Al never mislead anybody !! He put his money where his mouth was, and fought for what is most likely, one of the most significant advancements in care, that those living with Diabetes will ever see. Its one thing to sit on a stock message board and vent about the shareprice of Mannkind, but to just barf out bullshit statements such as this, make you appear either either stupid, or dishonest. If you’re going to put false words in somebody’s mouth, at least make it someone who can defend against the BS. 🤬 If you have been here as long as I have which I think you have, Then you should remeber Al Mann saying he thought this would be the biggest selling drug of all time. In spite of the share price the last 6 years, I still believe him. Yep, I remember, and after all this time, and all we as mnkd investors have been through, I still believe. Actually now more than ever !! And I just can’t wait to say “I told you !” to the people that have tried to convince me that I’m wrong. Just cant wait. ✌🏻😎 |
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Post by morgieporgie on Jul 29, 2018 21:31:10 GMT -5
Maybe Al wasn't the one who said that. My mistake, hey listen I make mistakes. I thought he did. Anyways, look, I believe in Afrezza as much as anyone here. Not happy with the companies' performance. It's that simple. No need to play message board barbarian. Let's talk why management can't execute. No need to play message board barbarian Now I challenge you to dig through my posting history, (other than this thread), and find any barbaric comments, or replies to comments. You are probably talking to one of the least confrontational members of this board. Read your comment that inspired my response, your comment was either made hastily without knowing what you were saying was true, or it was a flat out lie. I’m thinking it was an honest mistake, but regardless, my reply was accurate. Sorry for the delivery, but when replying to someone who puts so much emphasis on the truth, I felt I should let you know just how far from the truth you were. “Truth hurts sometimes, but I think it's healthy to know it” Right ?? I sincerely apologize for any unintended disrespect. ✌🏻 Read more: mnkd.proboards.com/thread/10272/reality-situation?page=6#ixzz5MgqyMwwyJust to straighten up the facts... You said that Al Mann said.. “take care of the Patients and the Shareprice will take care of itself” Actually, that's incorrect. Look up what he said and you'll see what I mean. Then come back and tell me you were wrong. If you can do that. Close but no cigar. Al wouldn't focus solely on the share price like that. |
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Post by sportsrancho on Jul 29, 2018 21:45:18 GMT -5
Al said that to Matt.
Matt had gone to Al because he was worried about the share price. Al said to Matt, don’t worry about the share price, concentrate on the patients and the stock will take care of itself.
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Post by peppy on Jul 29, 2018 21:47:36 GMT -5
No need to play message board barbarian Now I challenge you to dig through my posting history, (other than this thread), and find any barbaric comments, or replies to comments. You are probably talking to one of the least confrontational members of this board. Read your comment that inspired my response, your comment was either made hastily without knowing what you were saying was true, or it was a flat out lie. I’m thinking it was an honest mistake, but regardless, my reply was accurate. Sorry for the delivery, but when replying to someone who puts so much emphasis on the truth, I felt I should let you know just how far from the truth you were. “Truth hurts sometimes, but I think it's healthy to know it” Right ?? I sincerely apologize for any unintended disrespect. ✌🏻 Read more: mnkd.proboards.com/thread/10272/reality-situation?page=6#ixzz5MgqyMwwyJust to straighten up the facts... You said that Al Mann said.. “take care of the Patients and the Shareprice will take care of itself” Actually, that's incorrect. Look up what he said and you'll see what I mean. Then come back and tell me you were wrong. If you can do that. Close but no cigar. Al wouldn't focus solely on the share price like that. quote: Close but no cigar. reply: close only counts in horseshoes and hand grenades. I see we are the same age. |
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Post by nylefty on Jul 29, 2018 22:28:53 GMT -5
Al said that to Matt. Matt had gone to Al because he was worried about the share price. Al said to Matt, don’t worry about the share price, concentrate on the patients and the stock will take care of itself. But, but...that conversation wasn't captured by Google, so it could not have happened! (Sarcasm). |
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Post by morgieporgie on Jul 29, 2018 23:39:46 GMT -5
Just to straighten up the facts... You said that Al Mann said.. “take care of the Patients and the Shareprice will take care of itself” Actually, that's incorrect. Look up what he said and you'll see what I mean. Then come back and tell me you were wrong. If you can do that. Close but no cigar. Al wouldn't focus solely on the share price like that. quote: Close but no cigar. reply: close only counts in horseshoes and hand grenades. I see we are the same age. You know, I almost usef that one about the hand grenades? |
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Post by gamblerjag on Jul 29, 2018 23:57:37 GMT -5
Al said that to Matt. Matt had gone to Al because he was worried about the share price. Al said to Matt, don’t worry about the share price, concentrate on the patients and the stock will take care of itself. But, but...that conversation wasn't captured by Google, so it could not have happened! (Sarcasm). correct and when Al told Matt not to worry the price was $25 a share. 😀 |
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Post by mytakeonit on Jul 30, 2018 3:50:46 GMT -5
Al probably would have said it at $1.54 a share also. Al E. Newman also would have said ... "What ... me worry?"
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Post by peppy on Jul 30, 2018 8:03:20 GMT -5
I would agree. If the market sees Dr. Kendall deliver on the T1 inclusion there is little reason they should not think he will also be able to change the current T2 standard. However, the T2 hill is much steeper but the rewards significantly larger. Having t come before GLP-1 use would be huge and take the Trulicity market. Having it in its proper place which would be as step 1 with or without metformin and you are easily looking at 10x the IPO price. I really need to read the standard of care better. For some reason I only read the recommendations for Type 1 which pushes RAA. The section on insulin therapy for Type 1 already has a paragraph on Afrezza including this:
Rapid-acting inhaled insulin used before meals in patients with type 1 diabetes was shown to be noninferior when compared with aspart insulin for A1C lowering, with less hypoglycemia observed with inhaled insulin therapy.
Likewise the Type 2 section has a sub-section on Afrezza as well.
I think my original premise that this would be trivial to do for Type 1 might be wrong. It may be a bit harder than I had thought because Afrezza underperformed HbA1c reduction against RAA in the 171 trial. I still think it is possible though. The important thing is that inhaled insulin is already in the standard of care both for Type 1 and Type 2. Getting prandial insulin moved out of it's current sequence is going to be extremely difficult though and will take a big trial to make it happen - there is just to much trial evidence on the GLP-1 side as it stands. I think what Dr Kendall knows, and Mannkind previously never understood, is that you have to have a steady stream of evidence level A or B trials to fortify your position in the medical world. Quote: The section on insulin therapy for Type 1 already has a paragraph on Afrezza including this: Rapid-acting inhaled insulin used before meals in patients with type 1 diabetes was shown to be noninferior when compared with aspart insulin for A1C lowering, with less hypoglycemia observed with inhaled insulin therapy.Likewise the Type 2 section has a sub-section on Afrezza as well. reply: I noticed this as well. Consider: GENERAL CHANGES The field of diabetes care is rapidly changing as new research, technology, and treat- ments that can improve the health and well-being of people with diabetes continue to emerge. With annual updates since 1989, the American Diabetes Association’s (ADA’s) “Standards of Medical Care in Diabetes” (Standards of Care) has long been a leader in producing guidelines that capture the most current state of the field. Starting in 2018, the ADA will update the Standards of Care even more frequently online should the Professional Practice Committee de- termine that new evidence or regulatory changes merit immediate incorporation into the Standards of Care. In addition, the Standards of Care will now become the ADA’s sole source of clinical practice recommendations, superseding all prior position and scientific statements. Read more: mnkd.proboards.com/thread/10068/ada-2018-standards-care?page=2#ixzz5Mk6QQtsY |
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Post by goyocafe on Jul 30, 2018 9:38:46 GMT -5
I really need to read the standard of care better. For some reason I only read the recommendations for Type 1 which pushes RAA. The section on insulin therapy for Type 1 already has a paragraph on Afrezza including this:
Rapid-acting inhaled insulin used before meals in patients with type 1 diabetes was shown to be noninferior when compared with aspart insulin for A1C lowering, with less hypoglycemia observed with inhaled insulin therapy.
Likewise the Type 2 section has a sub-section on Afrezza as well.
I think my original premise that this would be trivial to do for Type 1 might be wrong. It may be a bit harder than I had thought because Afrezza underperformed HbA1c reduction against RAA in the 171 trial. I still think it is possible though. The important thing is that inhaled insulin is already in the standard of care both for Type 1 and Type 2. Getting prandial insulin moved out of it's current sequence is going to be extremely difficult though and will take a big trial to make it happen - there is just to much trial evidence on the GLP-1 side as it stands. I think what Dr Kendall knows, and Mannkind previously never understood, is that you have to have a steady stream of evidence level A or B trials to fortify your position in the medical world. Quote: The section on insulin therapy for Type 1 already has a paragraph on Afrezza including this: Rapid-acting inhaled insulin used before meals in patients with type 1 diabetes was shown to be noninferior when compared with aspart insulin for A1C lowering, with less hypoglycemia observed with inhaled insulin therapy.Likewise the Type 2 section has a sub-section on Afrezza as well. reply: I noticed this as well. Consider: GENERAL CHANGES The field of diabetes care is rapidly changing as new research, technology, and treat- ments that can improve the health and well-being of people with diabetes continue to emerge. With annual updates since 1989, the American Diabetes Association’s (ADA’s) “Standards of Medical Care in Diabetes” (Standards of Care) has long been a leader in producing guidelines that capture the most current state of the field. Starting in 2018, the ADA will update the Standards of Care even more frequently online should the Professional Practice Committee de- termine that new evidence or regulatory changes merit immediate incorporation into the Standards of Care. In addition, the Standards of Care will now become the ADA’s sole source of clinical practice recommendations, superseding all prior position and scientific statements. Read more: mnkd.proboards.com/thread/10068/ada-2018-standards-care?page=2#ixzz5Mk6QQtsY" Starting in 2018, the ADA will update the Standards of Care even more frequently online should the Professional Practice Committee de- termine that new evidence or regulatory changes merit immediate incorporation into the Standards of Care. In addition, the Standards of Care will now become the ADA’s sole source of clinical practice recommendations, superseding all prior position and scientific statements." Let's see how morally and ethically compelled they are to do so...and when. |
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