|
|
Post by sayhey24 on Jul 7, 2024 11:10:49 GMT -5
Remind me again. What is the benefit of inhalable GLP1? I know people on Ozempic and Wegovy. They’re not in the least deterred by a once-weekly subcutaneous injection. And for sure they care very much that it is helping them lose weight. I don’t know but do assume that the far majority of prescriptions for these drugs has almost everything to do with losing weight and almost nothing to do with diabetes. Benefit for MNKD or for the patient? For Mike he would going head to head with BP again which I think is a bit scary for him but he now has a win with Inhale-3. For MNKD its an easy entry into the $100B weight loss market. Phase 1a study has already been done with native GLP1 and it worked really well. Using an analog like Saxenda should be a no-brainer. Companies like Pfizer disagree with your statement about subq injections for the weight loss market and have been spending a fortune on an oral approach and not doing so well. There is also an unmet need in the "maintenance" space. Once the PWD comes off Ozempic a lower cost maintenance option is needed. If priced correctly Saxenda DPI should easily fill that space. For the patient this is what was said in the past A greater proportion of the GLP-1 inhaled as MKC253 remained intact during the period following administration than has been described in the literature following subcutaneous or intravenous injection of GLP-1. "Our hypothesis at present is that delivery of active GLP-1 to the arterial circulation via the lung avoids much of the degradation by dipeptidyl peptidase-4 that occurs prior to the compound reaching the primary site of endocrine action. Thus, we may be able to achieve a different response profile with pulmonary MCK253 than that seen with subcutaneous or intravenous administration of GLP-1. Moreover, the pulsatile administration of MKC253 achieved with our proprietary Technosphere delivery technology appears to avoid the dose-limiting vomiting characteristically associated with GLP-1 and replaces a physiological response lost in patients with diabetes that cannot be replicated by other forms of GLP-1," said Dr. Peter Richardson, Corporate Vice President and Chief Scientific Officer. "As well, with pulsatile delivery, we may potentially avoid unusual adverse effects such as the acute pancreatitis that has been described with presently marketed GLP analogues." "We believe that MKC253 represents a novel approach to the use of GLP-1 as a prandial therapy for diabetes either alone, or in combination with prandial insulin. In addition, if we are able to demonstrate the same weight reduction or satiety effects seen with long-acting analogues of native GLP, MKC253 may have therapeutic potential in obesity. www.diabetesincontrol.com/positive-results-for-inhaled-glp-1-cpd/ |
|
|
|
Post by sayhey24 on Jul 7, 2024 11:18:13 GMT -5
The expectation is the kids get approved. The expectation is Mike can take the Inhale-3 results and get SoC changes to justify insurance coverage. ... INHALE-3 still only managed non-inferior. Insurance decision are justified as outcome based and the outcome has not changed. What change are you expecting from the SoC that will force insurance cover? Hmmm - I guess you could argue it was only non-inferior 30% of inhaled insulin group reached <7% (HbA1c) at 17 weeks vs. 17% of the usual care group 21% of inhaled insulin group vs. 0% of usual care group met A1c goal of <7% if baseline was >7% 24% of the Afrezza group and 13% of the usual care group achieved TIR above 70% with no increased hypoglycemia in the inhaled insulin group No difference in CGM-measured hypoglycemia between the groups You ask - my expectations for the SoC? Mike has to get insurance coverage and I don't really care how he does it. His #1 job right now is to get insurance coverage before pediatric approval. What ever he needs to do to get the proper words put in the SoC to help get the coverage and promoted expanded scripts is my expectation. |
|
|
|
Post by cretin11 on Jul 7, 2024 12:53:37 GMT -5
Good luck with that expectation 🙏🏽🤞🏽
It’s also my hope Mike can get traction with insurance/SoC but definitely not an expectation at this point.
|
|
|
|
Post by uvula on Jul 7, 2024 14:41:48 GMT -5
We have been over this before. If a study is designed to show non inferiority, the strongest statement you can make after the study is that it proved to be noninferior.
You can ask why mnkd chose to go for non-inferiority but that is irrelevant at this point.
|
|
|
|
Post by agedhippie on Jul 7, 2024 15:30:14 GMT -5
INHALE-3 still only managed non-inferior. Insurance decision are justified as outcome based and the outcome has not changed. What change are you expecting from the SoC that will force insurance cover? ... You ask - my expectations for the SoC? Mike has to get insurance coverage and I don't really care how he does it. His #1 job right now is to get insurance coverage before pediatric approval. What ever he needs to do to get the proper words put in the SoC to help get the coverage and promoted expanded scripts is my expectation. The problem is this - At 17 weeks, technosphere insulin was noninferior to usual care, with the technosphere insulin group having an HbA1c of 7.6% and the usual care group having a 7.5% HbA1c (P = .01 for noninferiority). Insurers will argue that RAA and Afrezza deliver the same outcome and therefore there is no reason for them to cover Afrezza since they cover RAA. That's a show stopper - how does Mike get around that? |
|
|
|
Post by mymann on Jul 7, 2024 23:20:56 GMT -5
... You ask - my expectations for the SoC? Mike has to get insurance coverage and I don't really care how he does it. His #1 job right now is to get insurance coverage before pediatric approval. What ever he needs to do to get the proper words put in the SoC to help get the coverage and promoted expanded scripts is my expectation. The problem is this - At 17 weeks, technosphere insulin was noninferior to usual care, with the technosphere insulin group having an HbA1c of 7.6% and the usual care group having a 7.5% HbA1c (P = .01 for noninferiority). Insurers will argue that RAA and Afrezza deliver the same outcome and therefore there is no reason for them to cover Afrezza since they cover RAA. That's a show stopper - how does Mike get around that? So what was great about the study results? It's just as good as the current mainstream treatment but cost more? |
|
|
|
Post by letitride on Jul 8, 2024 0:25:15 GMT -5
The results of inhale 3 are not complete until October and will not be posted until after that. So the show goes on. There is more than one way to skin a cat.
|
|
|
|
Post by sayhey24 on Jul 8, 2024 7:14:31 GMT -5
... You ask - my expectations for the SoC? Mike has to get insurance coverage and I don't really care how he does it. His #1 job right now is to get insurance coverage before pediatric approval. What ever he needs to do to get the proper words put in the SoC to help get the coverage and promoted expanded scripts is my expectation. The problem is this - At 17 weeks, technosphere insulin was noninferior to usual care, with the technosphere insulin group having an HbA1c of 7.6% and the usual care group having a 7.5% HbA1c (P = .01 for noninferiority). Insurers will argue that RAA and Afrezza deliver the same outcome and therefore there is no reason for them to cover Afrezza since they cover RAA. That's a show stopper - how does Mike get around that? Mike's primary job right now after making payroll is to get insurance coverage for afrezza. Its not MNKD-101 or 201. Its getting afrezza insurance coverage if he does not want to reduce the price. If you think insurance companies are going to point to the 7.6% A1C then Mike has 6 months to fix that. That is his #1 job. There is no mystery here. Those that did not get the great numbers are not properly dosing according to the "All Star" team which presented the results. With connected care that is not really that hard to fix. They need to be txting and calling these people. They can see exactly when they are dosing and when they are not from the real-time CGM reports. If everyone of these people needs a personal coach then Mike needs to get them one. At this point it needs to be no holds barred to get insurance coverage before pediatric approval. |
|
|
|
Post by agedhippie on Jul 8, 2024 8:20:15 GMT -5
... If you think insurance companies are going to point to the 7.6% A1C then Mike has 6 months to fix that. That is his #1 job. There is no mystery here. Those that did not get the great numbers are not properly dosing according to the "All Star" team which presented the results. With connected care that is not really that hard to fix. They need to be txting and calling these people. They can see exactly when they are dosing and when they are not from the real-time CGM reports. If everyone of these people needs a personal coach then Mike needs to get them one. ... People not dosing properly is a fact of life and why large scale trials matter. That is incredibly hard to fix. You cannot hire coaches because it's not in the protocol. More importantly the doctors are going to ask if the only way Afrezza works is if every patient has a coach because that will not scale. As for texting and calling my suspicion is that number will be blocked instantly, nobody likes being harassed. It is not possible to see what people are dosing unless they are using Bluhale, and even then probably not because you don't know what they ate. |
|
|
|
Post by prcgorman2 on Jul 8, 2024 8:49:51 GMT -5
The problem is this - At 17 weeks, technosphere insulin was noninferior to usual care, with the technosphere insulin group having an HbA1c of 7.6% and the usual care group having a 7.5% HbA1c (P = .01 for noninferiority). Insurers will argue that RAA and Afrezza deliver the same outcome and therefore there is no reason for them to cover Afrezza since they cover RAA. That's a show stopper - how does Mike get around that? Mike's primary job right now after making payroll is to get insurance coverage for afrezza. Its not MNKD-101 or 201. Its getting afrezza insurance coverage if he does not want to reduce the price. If you think insurance companies are going to point to the 7.6% A1C then Mike has 6 months to fix that. That is his #1 job. There is no mystery here. Those that did not get the great numbers are not properly dosing according to the "All Star" team which presented the results. With connected care that is not really that hard to fix. They need to be txting and calling these people. They can see exactly when they are dosing and when they are not from the real-time CGM reports. If everyone of these people needs a personal coach then Mike needs to get them one. At this point it needs to be no holds barred to get insurance coverage before pediatric approval. I do not agree that Mike's #1 job is getting insurance coverage for Afrezza. His company manufactures 2 FDA-approved drugs, one of which is making MannKind profitable. And, I think MannKind is also manufacturing clofazimine, although I don't know if that is the long-term plan assuming the Fast Track approval happens. The nintedanib trial was supposed to start registering patients last month. Mike's #1 job is providing executive leadership of MannKind which is neither a single-drug company nor dependent on Afrezza for ultimate success, and I am very grateful for that. |
|
|
|
Post by sayhey24 on Jul 8, 2024 8:55:35 GMT -5
... If you think insurance companies are going to point to the 7.6% A1C then Mike has 6 months to fix that. That is his #1 job. There is no mystery here. Those that did not get the great numbers are not properly dosing according to the "All Star" team which presented the results. With connected care that is not really that hard to fix. They need to be txting and calling these people. They can see exactly when they are dosing and when they are not from the real-time CGM reports. If everyone of these people needs a personal coach then Mike needs to get them one. ... People not dosing properly is a fact of life and why large scale trials matter. That is incredibly hard to fix. You cannot hire coaches because it's not in the protocol. More importantly the doctors are going to ask if the only way Afrezza works is if every patient has a coach because that will not scale. As for texting and calling my suspicion is that number will be blocked instantly, nobody likes being harassed. It is not possible to see what people are dosing unless they are using Bluhale, and even then probably not because you don't know what they ate. On the CGM reports you can tell if the people are not dosing or not dosing enough. Its pretty easy. It was also discussed by the one doctor that "some" people did not want to dose before bed. I understand their concern but if they don't want to follow the protocol and are being noncompliant then they should not be counted in the final A1c number. It has already crossed my mind BP has their finger on the scale here and yes I have my tin foil hat on. You see, I don't really care how Mike gets insurance coverage. Inhale-3 demonstrated when properly dosed afrezza wins. At this point 100% of Mike's focus needs to be getting insurance coverage before pediatric approval. If he can't do it then we need to get someone who can. Getting pediatric approval and gestational approval without insurance is a complete waste of time unless he has another approach to addressing the "cost" issue. |
|
|
|
Post by peppy on Jul 8, 2024 9:03:52 GMT -5
... If you think insurance companies are going to point to the 7.6% A1C then Mike has 6 months to fix that. That is his #1 job. There is no mystery here. Those that did not get the great numbers are not properly dosing according to the "All Star" team which presented the results. With connected care that is not really that hard to fix. They need to be txting and calling these people. They can see exactly when they are dosing and when they are not from the real-time CGM reports. If everyone of these people needs a personal coach then Mike needs to get them one. ... People not dosing properly is a fact of life and why large scale trials matter. That is incredibly hard to fix. You cannot hire coaches because it's not in the protocol. More importantly the doctors are going to ask if the only way Afrezza works is if every patient has a coach because that will not scale. As for texting and calling my suspicion is that number will be blocked instantly, nobody likes being harassed. It is not possible to see what people are dosing unless they are using Bluhale, and even then probably not because you don't know what they ate. , Subq Rapid Acting insulin is incredibly difficult to dose. According to Molly when her father was diagnosed he was given regular insulin and boiled his needles. By memory 1 and 1/2 to two hours to peak, and 5 to 6 hours out of system with no first phase insulin reaction so glycogen into glucose. Jesse Louise. These days there is an internet that can teach and coach. www.youtube.com/watch?v=Hej7L4BiVUMwww.youtube.com/watch?v=fTCsK6DQhSQI can teach afrezza. Take a dose with the first bite, after 1 hour if over 120 take another dose, probably a 4 unit if a type one diabetic. By the way, off topic, it looks to my eyeballs like the shorts are covering. |
|
|
|
Post by sayhey24 on Jul 8, 2024 10:02:38 GMT -5
Mike's primary job right now after making payroll is to get insurance coverage for afrezza. Its not MNKD-101 or 201. Its getting afrezza insurance coverage if he does not want to reduce the price. If you think insurance companies are going to point to the 7.6% A1C then Mike has 6 months to fix that. That is his #1 job. There is no mystery here. Those that did not get the great numbers are not properly dosing according to the "All Star" team which presented the results. With connected care that is not really that hard to fix. They need to be txting and calling these people. They can see exactly when they are dosing and when they are not from the real-time CGM reports. If everyone of these people needs a personal coach then Mike needs to get them one. At this point it needs to be no holds barred to get insurance coverage before pediatric approval. I do not agree that Mike's #1 job is getting insurance coverage for Afrezza. His company manufactures 2 FDA-approved drugs, one of which is making MannKind profitable. And, I think MannKind is also manufacturing clofazimine, although I don't know if that is the long-term plan assuming the Fast Track approval happens. The nintedanib trial was supposed to start registering patients last month. Mike's #1 job is providing executive leadership of MannKind which is neither a single-drug company nor dependent on Afrezza for ultimate success, and I am very grateful for that. Al Mann put $1B+ of his own money into afrezza because he believed it would become the greatest selling drug of all time. Clofazmine and nitedanib were on Al's TS list but pretty far down. The potential for afrezza sales dwafts both combined. Enough of the distractions. Last year it was V-Go before that Damon Dash. Afrezza has three issues which have prevented it from selling; 1 - label; 2 - SoC; 3 - Cost. Those three issues need to be addressed. Inhale-3 has demonstrated afrezza can be as good as Al Mann believed and can help address issue's 1 and 2. Mike's #1 job is to address issue #3 and if that means getting insurance coverage then thats what he needs to do. This should be done prior to Pediatric approval. Afrezza got some good news coverage on the Inhale-3 results but once the kids are approved the news coverage will be HUGE. MNKD needs to be ready for this. Thats what I call "Executive Leadership". How many people work at MNKD - 300? In a 300 person company the executive needs to roll up their sleeves and get to work. |
|
|
|
Post by dh4mizzou on Jul 8, 2024 10:09:02 GMT -5
sayhey24,
Not being a snot here but how does Mike go about GETTING insurance coverage? I'm asking because I am a total novice and have no understanding of how that is done.
|
|
|
|
Post by peppy on Jul 8, 2024 10:29:10 GMT -5
sayhey24, Not being a snot here but how does Mike go about GETTING insurance coverage? I'm asking because I am a total novice and have no understanding of how that is done. I believe I have learned in order for Afrezza to receive insurance coverage, Afrezza must be shown to be superior. Among non-inferior insulin label the pharmacy purchasing manager decides what insulin their insurance covers. |
|
