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Post by stevil on May 8, 2019 0:30:35 GMT -5
Wait, you were the super glucose fighting powder guy, right? So never mind on the authority part. I'm just curious why you continue to bang the Endos aren't our friends and PCP's don't know how to treat PWD's drum. What has given you that impression since you're not in the healthcare field?
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Post by matt on May 8, 2019 6:52:15 GMT -5
Sports - we have been saying for a long time until significant changes are made to the SOC afrezza scripts will grow but they will grow very slowly. TV ads are not going to sell afrezza but I think the TV ads worked out better than I expected as a lot of people saw them and afrezza is no longer a total unknown. When Mike gets serious about selling afrezza he will partner to open dedicated health and wellness clinics which specialize in diabetes and leverage CGM and connected care technology and afrezza. I would expect each clinic to do a minimum of 100 scripts per week which is a lot more than our current sales staff is doing. and the clinics would be profitable. Endos are not our friend and PCPs just don't have the focus to properly treat PWDs. What you are suggesting is the corporate practice of medicine which is illegal in every state. Ultimately every clinic needs to be owned by a physician licensed to practice in that state, and their compensation cannot be tied to prescribing any particular treatment without violating the Stark Act or a host of other federal and state laws. The fact that VDEX exists is good, but if the company gets tied up with VDEX contractually then both VDEX and MNKD will be in hot water. There is promise in helping to set up clinics with a concept similar to VDEX just so long as the clinic is financially independent. The issue that raises is that the physician must have deep enough pockets to cover the cost of operating the clinic in the absence of insurance reimbursement which will be minimal, at least at first. This strategy would be possible, even with a non-inferior designation on the label, but somebody still has to write the checks or the clinic fails, and managed care does not seem interested in covering Afrezza in a big way. When a particular treatment gets reimbursed, there are plenty of physicians who can figure out how to make a buck out of it but there are many promising technologies that never see the light of day because of reimbursement issues. Fix reimbursement and Afrezza will be fine, but that is easier said than done.
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Post by Deleted on May 8, 2019 7:05:27 GMT -5
Sports - we have been saying for a long time until significant changes are made to the SOC afrezza scripts will grow but they will grow very slowly. TV ads are not going to sell afrezza but I think the TV ads worked out better than I expected as a lot of people saw them and afrezza is no longer a total unknown. When Mike gets serious about selling afrezza he will partner to open dedicated health and wellness clinics which specialize in diabetes and leverage CGM and connected care technology and afrezza. I would expect each clinic to do a minimum of 100 scripts per week which is a lot more than our current sales staff is doing. and the clinics would be profitable. Endos are not our friend and PCPs just don't have the focus to properly treat PWDs. What you are suggesting is the corporate practice of medicine which is illegal in every state. Ultimately every clinic needs to be owned by a physician licensed to practice in that state, and their compensation cannot be tied to prescribing any particular treatment without violating the Stark Act or a host of other federal and state laws. The fact that VDEX exists is good, but if the company gets tied up with VDEX contractually then both VDEX and MNKD will be in hot water. There is promise in helping to set up clinics with a concept similar to VDEX just so long as the clinic is financially independent. The issue that raises is that the physician must have deep enough pockets to cover the cost of operating the clinic in the absence of insurance reimbursement which will be minimal, at least at first. This strategy would be possible, even with a non-inferior designation on the label, but somebody still has to write the checks or the clinic fails, and managed care does not seem interested in covering Afrezza in a big way. When a particular treatment gets reimbursed, there are plenty of physicians who can figure out how to make a buck out of it but there are many promising technologies that never see the light of day because of reimbursement issues. Fix reimbursement and Afrezza will be fine, but that is easier said than done. There is a guy in Seattle who has a company that sells books online. Word has it he recently bought a high end grocery chain. This guy has been hiring all sorts of people with significant experience in the pharmaceutical industry. Me thinks if Bezos wanted to he could set up a store within a store concept in the vitamin / health section of Whole Foods and staff it with a CNP with a diabetes focus. If patient Doe needs to speak with an MD, that could be done on the spot via encrypted video conference to an Amazon MD located off site. In a fee for outcomes world, patient Doe would also be given intensive nutrition education via in store and video programs. Patient Doe can be incentivized for achieving certain metrics, time in range, weight loss or control, proper nutrition, exercising... And that new Dex G7 sensor thats coming out late 2020 is a lot smaller and less expensive than anything they have ever produced and it will send data directly to patient Doe's smartphone and from there, that data could be sent to AWS for analysis and warehousing. If someone cracks the holy grail of time in range, fee for outcomes will be the golden goose and in the right reimbursement scenario, the provider can give a patient their Rx products at no charge and hell, if the time in range is good enough, Whole Foods might even be able to collect some type of reimbursement for healthy food for patient Doe from the insurance company. Keep in mind Matt, using the current benchmark, A1c patient time in range and otherwise control of BG levels is abysmal. Diabetes and its associated healthcare costs will bankrupt the US healthcare system, its no longer if but when. The DCCT validated the economic, clinical and human benefits of very tight control of BG levels 20+ years ago. The advent of CGMs is the conduit to measure patient performance in a way that even a few years ago was not possible. What pisses me off so much about the Mannkind fiasco is that I have no doubt that Afrezza is the best advancement in diabetes care since Banting did his insulin thing. Why MC can't sell more of it now has me scratching my head. His salesforce must absolutely suck or not be working.
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Post by matt on May 8, 2019 8:41:57 GMT -5
Keep in mind Matt, using the current benchmark, A1c patient time in range and otherwise control of BG levels is abysmal. Diabetes and its associated healthcare costs will bankrupt the US healthcare system, its no longer if but when. The DCCT validated the economic, clinical and human benefits of very tight control of BG levels 20+ years ago. The advent of CGMs is the conduit to measure patient performance in a way that even a few years ago was not possible. I won't even try to disagree that control of A1c is pretty bad in a significant number of patients. I have written a number of clinical trial protocols that attempted to allow reasonably well-controlled diabetics into the trial and exclude those who were seriously out of range. I have had to move the goal posts for inclusion on some trials to those that achieve A1c levels of 10%, and even then there were issues with enrollment. The well-controlled diabetic with an A1c < 6.5% is observed about as often as unicorns, at least in those with advanced disease, most of whom are Type II and the DCCT trial was done on Type I. At any rate, I don't think anybody with significant medical experience would argue your point that a well-controlled patient is less expensive to treat than a poorly-controlled patient. The problem with Afrezza is that they cannot demonstrate that they are superior to cheaper alternatives (it says so right on the label), and that is what prevents managed care from covering the drug. Had MNKD done economic studies along with the pharmacology studies during the development phase, they might have the necessary data to argue that the higher price for Afrezza is justified by superior economic outcomes (managed care is all about better economics). While it may seem obvious to some that Afrezza does a better job of controlling post prandial glucose levels and therefore should translate to lower long-term costs, the insurers want to see the data with some hard numbers attached. Are the savings enough to justify a $400 per month insulin, a $600 per month insulin, or an $800 per month insulin? Those are numbers the manufacturer needs to come up with (suitably audited by an independent third-party) because the insurance industry is not going to do the work themselves. That is a long and costly study, but one that needs to be done. Unquantified benefits, no matter how real they may be, don't move the needle on managed care acceptance; hard numbers do.
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Post by sweedee79 on May 8, 2019 11:04:09 GMT -5
Wait, you were the super glucose fighting powder guy, right? So never mind on the authority part. I'm just curious why you continue to bang the Endos aren't our friends and PCP's don't know how to treat PWD's drum. What has given you that impression since you're not in the healthcare field? Seyhey is quite knowledgeable about. What is going on.. many of us here are.. you don't have to be in the healthcare field to see what is going on. I don't mean to be rude, but just because you are in the healthcare field doesn't make you an authority on what is going on with Afrezza. There are many healthcare professionals that obviously don't understand Afrezza and don't want to. I've been around the block with that. Docs who do understand Afrezza are having remarkable results. What Seyhey says is true.. he isn't beating any drum anymore than you are...
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Post by sportsrancho on May 8, 2019 11:13:32 GMT -5
Wait, you were the super glucose fighting powder guy, right? So never mind on the authority part. I'm just curious why you continue to bang the Endos aren't our friends and PCP's don't know how to treat PWD's drum. What has given you that impression since you're not in the healthcare field? Seyhey is quite knowledgeable about. What is going on.. many of us here are.. you don't have to be in the healthcare field to see what is going on. I don't mean to be rude, but just because you are in the healthcare field doesn't make you an authority on what is going on with Afrezza. There are many healthcare professionals that obviously don't understand Afrezza and don't want to. I've been around the block with that. Docs who do understand Afrezza are having remarkable results. What Seyhey says is true.. he isn't beating any drum anymore than you are... I second that! I think someone has taken over stevil’s ID🤣 this is not how I remember him. Sayhey knows of what he speaks I’m just gonna leave it at that.
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Post by Deleted on May 8, 2019 11:14:40 GMT -5
Keep in mind Matt, using the current benchmark, A1c patient time in range and otherwise control of BG levels is abysmal. Diabetes and its associated healthcare costs will bankrupt the US healthcare system, its no longer if but when. The DCCT validated the economic, clinical and human benefits of very tight control of BG levels 20+ years ago. The advent of CGMs is the conduit to measure patient performance in a way that even a few years ago was not possible. I won't even try to disagree that control of A1c is pretty bad in a significant number of patients. I have written a number of clinical trial protocols that attempted to allow reasonably well-controlled diabetics into the trial and exclude those who were seriously out of range. I have had to move the goal posts for inclusion on some trials to those that achieve A1c levels of 10%, and even then there were issues with enrollment. The well-controlled diabetic with an A1c < 6.5% is observed about as often as unicorns, at least in those with advanced disease, most of whom are Type II and the DCCT trial was done on Type I. At any rate, I don't think anybody with significant medical experience would argue your point that a well-controlled patient is less expensive to treat than a poorly-controlled patient. The problem with Afrezza is that they cannot demonstrate that they are superior to cheaper alternatives (it says so right on the label), and that is what prevents managed care from covering the drug. Had MNKD done economic studies along with the pharmacology studies during the development phase, they might have the necessary data to argue that the higher price for Afrezza is justified by superior economic outcomes (managed care is all about better economics). While it may seem obvious to some that Afrezza does a better job of controlling post prandial glucose levels and therefore should translate to lower long-term costs, the insurers want to see the data with some hard numbers attached. Are the savings enough to justify a $400 per month insulin, a $600 per month insulin, or an $800 per month insulin? Those are numbers the manufacturer needs to come up with (suitably audited by an independent third-party) because the insurance industry is not going to do the work themselves. That is a long and costly study, but one that needs to be done. Unquantified benefits, no matter how real they may be, don't move the needle on managed care acceptance; hard numbers do. I hear you on the study but that is not going to happen. Mannkind has neither the time or money for it but I am sure given your experience, you knew that already. What the company could have and should have done some time ago is try to work with an insurer that they have very good relationships with and get XXX type one patients who were already on CGMs to participate in a study to determine how their use of Afrezza impacts their time in range, A1c as well as participants subjective thoughts on how Afrezza is in terms of ease of use and impact on lifestyle. If the results were good enough and I believe they would have been, that information could make for a compelling case to the insurance company whose patients participated. The downside of this of course is the insurance company likely has contracts with other Rx manufacturers so they may not be eager to try to move the bulk of patients over to Afrezza. Mannkind never achieved critical mass, that is enough patients singing the praises of Afrezza to the point where enough perspective patients demanded the product. The company needs around $55 mm to break even and a stronger sales growth trajectory up to and past this point would have demonstrated to the street the product had legs. I would think that had Afrezza sales been trending toward $42-44mm this year, the SP would have responded because that trajectory repeated again in 2020 would have had sales coming in around $105mm but that ain't happening. Historically the docs were hesitant to get A1c much below the 7s due to fears of hypoglycemia. Afrezza would have allowed for A1c levels in the 6s or lower without hypoglycemia as we have already seen in many Afrezza users. The diabetes industrial complex is alive and well. Matt, ideas as to what Afrezza would fetch if Mannkind did a deal where they got a cut but turned over ownership to another entity? Do you think the company has enough data to make a compelling case to another entity that with more resources, strong sales growth is possible within 12 - 18 months or is there simply too much clinical trial work that still needs to happen before Afrezza's unique qualities can be openly spoken about with clinicians, payors and patients?
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Post by mango on May 8, 2019 11:40:08 GMT -5
Wait, you were the super glucose fighting powder guy, right? So never mind on the authority part. I'm just curious why you continue to bang the Endos aren't our friends and PCP's don't know how to treat PWD's drum. What has given you that impression since you're not in the healthcare field? Seyhey is quite knowledgeable about. What is going on.. many of us here are.. you don't have to be in the healthcare field to see what is going on. I don't mean to be rude, but just because you are in the healthcare field doesn't make you an authority on what is going on with Afrezza. There are many healthcare professionals that obviously don't understand Afrezza and don't want to. I've been around the block with that. Docs who do understand Afrezza are having remarkable results. What Seyhey says is true.. he isn't beating any drum anymore than you are... I second that emotion🕺🏻
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Post by ktim on May 8, 2019 11:44:24 GMT -5
Sports - we have been saying for a long time until significant changes are made to the SOC afrezza scripts will grow but they will grow very slowly. TV ads are not going to sell afrezza but I think the TV ads worked out better than I expected as a lot of people saw them and afrezza is no longer a total unknown. When Mike gets serious about selling afrezza he will partner to open dedicated health and wellness clinics which specialize in diabetes and leverage CGM and connected care technology and afrezza. I would expect each clinic to do a minimum of 100 scripts per week which is a lot more than our current sales staff is doing. and the clinics would be profitable.Endos are not our friend and PCPs just don't have the focus to properly treat PWDs. Medicare and Medicaid would not cover clinics that are owned by a pharma to push their own products. I doubt commercial health insurance would either.
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Post by mymann on May 8, 2019 12:47:50 GMT -5
If you get Doctors become part owners of a clinic and if the Doctors create a Corporation which can partner with Mannkind, could this help solve the Medicare and Medicaid issues?
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Post by Deleted on May 8, 2019 12:50:14 GMT -5
What you are suggesting is the corporate practice of medicine which is illegal in every state. Ultimately every clinic needs to be owned by a physician licensed to practice in that state, and their compensation cannot be tied to prescribing any particular treatment without violating the Stark Act or a host of other federal and state laws. The fact that VDEX exists is good, but if the company gets tied up with VDEX contractually then both VDEX and MNKD will be in hot water. There is promise in helping to set up clinics with a concept similar to VDEX just so long as the clinic is financially independent. The issue that raises is that the physician must have deep enough pockets to cover the cost of operating the clinic in the absence of insurance reimbursement which will be minimal, at least at first. This strategy would be possible, even with a non-inferior designation on the label, but somebody still has to write the checks or the clinic fails, and managed care does not seem interested in covering Afrezza in a big way. When a particular treatment gets reimbursed, there are plenty of physicians who can figure out how to make a buck out of it but there are many promising technologies that never see the light of day because of reimbursement issues. Fix reimbursement and Afrezza will be fine, but that is easier said than done. There is a guy in Seattle who has a company that sells books online. Word has it he recently bought a high end grocery chain. This guy has been hiring all sorts of people with significant experience in the pharmaceutical industry. Me thinks if Bezos wanted to he could set up a store within a store concept in the vitamin / health section of Whole Foods and staff it with a CNP with a diabetes focus. If patient Doe needs to speak with an MD, that could be done on the spot via encrypted video conference to an Amazon MD located off site. In a fee for outcomes world, patient Doe would also be given intensive nutrition education via in store and video programs. Patient Doe can be incentivized for achieving certain metrics, time in range, weight loss or control, proper nutrition, exercising... And that new Dex G7 sensor thats coming out late 2020 is a lot smaller and less expensive than anything they have ever produced and it will send data directly to patient Doe's smartphone and from there, that data could be sent to AWS for analysis and warehousing. If someone cracks the holy grail of time in range, fee for outcomes will be the golden goose and in the right reimbursement scenario, the provider can give a patient their Rx products at no charge and hell, if the time in range is good enough, Whole Foods might even be able to collect some type of reimbursement for healthy food for patient Doe from the insurance company. Keep in mind Matt, using the current benchmark, A1c patient time in range and otherwise control of BG levels is abysmal. Diabetes and its associated healthcare costs will bankrupt the US healthcare system, its no longer if but when. The DCCT validated the economic, clinical and human benefits of very tight control of BG levels 20+ years ago. The advent of CGMs is the conduit to measure patient performance in a way that even a few years ago was not possible. What pisses me off so much about the Mannkind fiasco is that I have no doubt that Afrezza is the best advancement in diabetes care since Banting did his insulin thing. Why MC can't sell more of it now has me scratching my head. His salesforce must absolutely suck or not be working. Someone should send this to Castagna, www.amazon.com/stores/page/5C6C0A16-CE60-4998-B799-A746AE18E19B?channel=hmd_190420 - watch the video www.biopharmadive.com/news/meet-pillpack-amazon-rolls-out-rx-delivery-direct-marketing/553380/
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Post by harryx1 on May 8, 2019 13:06:26 GMT -5
I wonder if this means more TS molecules coming to the pipeline in the near future!?!?!?!
"I'm very proud to announce that during Q2 we started to build out the factory to make high-potency molecules, which establishes a new capability within MannKind." - Mike
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Post by mannmade on May 8, 2019 13:14:15 GMT -5
Harry I took it to mean they are working on prepping for Trep T to produce for trials and until UTHR builds their own production facility.
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Post by compound26 on May 8, 2019 13:18:42 GMT -5
Harry I took it to mean they are working on prepping for Trep T to produce for trials and until UTHR builds their own production facility. Yes, based on my understanding of Mike's presentation, the completion of the building of this manufacturing facility (for Trep) is the condition for UTHR to pay the next $12.5 million of the milestone payments.
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Post by harryx1 on May 8, 2019 13:20:10 GMT -5
Then why state a new capability within Mannkind
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