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Post by brotherm1 on Jan 8, 2020 12:13:25 GMT -5
Sayhey, would you know if these two studies are large or should we expect a new SOC to again say no large studies have been completed? India is the large T2 study - hopefully Dr. Kendall is fully engaged in the design. It would be nice to seem them leveraging Onduo and Onduo's partner Dexcom. Is the India trial a superiority trial Aged is saying we should have?
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Post by agedhippie on Jan 8, 2020 12:21:03 GMT -5
I am curious why you think endos are going to start promoting Afrezza by T1s more now and didn't do it last year. Aged - I am not "thinking" it. This is what Mike said his plan was. Why now? Several reasons, here are a few; Mike has a few years of experience and has learned from his failures; CGM's have now come of age and every endo now has experience with them; As a result realtime BG, CGM numbers matter and A1c not so much; afrezza is the only real time solution and CGMs let you see those results - seeing is believing; afrezza lung safety has had outstanding results with some seeing improved FEV1; MNKD now has a large T1 study result analysis to couple with the STAT results; Dr. Kendall moved the "Borge" and got meaningful words in the SoC; hypos, hypos, hypos and afrezza will reduce them is something Endos understand; AND the kids will be approved later this year. Once you have the kids day 1 they will be afrezza users for life. Mike is going to hit the endos early and hard in preparing for the kids. No one wants kids getting hypos, especially their moms. Aged - have you ever dealt with "soccer moms"? I have and I think moms of T1s have a greater passion. Nice to know Mike was learning on the job considering the reason he was originally hired was because he was meant to be an expert in this area. CGMs have been of age for years. A Type 1 can relatively easily get a CGM and that has been the case for at least the seven or eight years and every endo has had experience of them for a lot longer. The take up is still limited and you have to ask why (this is aside from people who have CGMs but seldom use them). The last big barrier was Medicare, and that went two years ago. The uptake in CGMs is going to be driven by integration into pumps, and that is not to Mannkind's advantage. The large T1 study I think you mean is the analysis of the Affinity-1 data from six years ago. That is not going to move the needle, plus the data is not exactly earth moving. I doubt you are going to get many endos looking at that and deciding now is the time to start moving stable patients onto a new regime. If you want that move you need compelling data - STAT-2! I was curious what had changed in the SoC between this year and last year. Turns out the wording on hypos is exactly the same so no change there then. Notice (because doctors will) that it says may reduce, not does or will reduce. That is going to be enough to get it disregarded for pro-active change. The SOC will not change without a large scale trial, that's just the way it is. I definitely think there is an age range where pediatric uptake will be big.
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Post by peppy on Jan 8, 2020 14:16:04 GMT -5
I was under the impression, that when physicians see a medication work extremely well for their patients and their patients are happier; is the reason physicians put more of their patients on that medication. That and health insurance coverage. sorry about that run on sentence above. I think you are correct. That begs the question as to why after five years there has not been any serious take up. My feeling is that the case has not been made in a compelling way and the doctors are going with what they view as working. How could it be made more compelling? Run a superiority trial. Without that nothing changes despite what people have been repeatedly saying for years. Aged, there really is quite a bit of pent up demand for Afrezza vs injectable RAA's. Granted not every type one RAA user wants to switch. I remember reading on tudiabtes a lady who had a pump and had a continuous glucose monitor and stated it took her a long time to get those devices and she wasn't going to change. Pent up demand just the same shut down by insurance coverage. Love you.
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Post by agedhippie on Jan 8, 2020 15:21:23 GMT -5
I think you are correct. That begs the question as to why after five years there has not been any serious take up. My feeling is that the case has not been made in a compelling way and the doctors are going with what they view as working. How could it be made more compelling? Run a superiority trial. Without that nothing changes despite what people have been repeatedly saying for years. Aged, there really is quite a bit of pent up demand for Afrezza vs injectable RAA's. Granted not every type one RAA user wants to switch. I remember reading on tudiabtes a lady who had a pump and had a continuous glucose monitor and stated it took her a long time to get those devices and she wasn't going to change. Pent up demand just the same shut down by insurance coverage. Love you. I have no problem believing there is a pent up demand from people blocked by insurers. I would be cautious about the size. I could see a lot of demand for the "rescue inhaler" usage pattern.
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Post by peppy on Jan 8, 2020 16:45:04 GMT -5
Aged, there really is quite a bit of pent up demand for Afrezza vs injectable RAA's. Granted not every type one RAA user wants to switch. I remember reading on tudiabtes a lady who had a pump and had a continuous glucose monitor and stated it took her a long time to get those devices and she wasn't going to change. Pent up demand just the same shut down by insurance coverage. Love you. I have no problem believing there is a pent up demand from people blocked by insurers. I would be cautious about the size. I could see a lot of demand for the "rescue inhaler" usage pattern. the people want that also. because they got a sample, used it to adjust their RAA post meal high down or stubborn out of no where high down. yes.
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Post by prcgorman2 on Jan 8, 2020 18:05:04 GMT -5
India is the large T2 study - hopefully Dr. Kendall is fully engaged in the design. It would be nice to seem them leveraging Onduo and Onduo's partner Dexcom. Is the India trial a superiority trial Aged is saying we should have? Great question, really. I probably shouldn't have a nagging feeling about acceptance in the US of results of a study in India, but I do. India regularly produces world class engineers, doctors, lawyers, executives, et cetera, but I can't shake the feeling a large clinical trial of Afrezza in India will not gain the same acceptance that a large US trial would. If so I suspect it might be partially due to cultural bias at least in terms of diet (much larger population with predominantly vegan diet) as well as concerns with trial design and execution. I am curious how aged and Matt (or one of the doctor that has occasionally posted) view portability of influence from a large trial in India.
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Post by sayhey24 on Jan 8, 2020 18:47:59 GMT -5
Aged - I am not "thinking" it. This is what Mike said his plan was. Why now? Several reasons, here are a few; Mike has a few years of experience and has learned from his failures; CGM's have now come of age and every endo now has experience with them; As a result realtime BG, CGM numbers matter and A1c not so much; afrezza is the only real time solution and CGMs let you see those results - seeing is believing; afrezza lung safety has had outstanding results with some seeing improved FEV1; MNKD now has a large T1 study result analysis to couple with the STAT results; Dr. Kendall moved the "Borge" and got meaningful words in the SoC; hypos, hypos, hypos and afrezza will reduce them is something Endos understand; AND the kids will be approved later this year. Once you have the kids day 1 they will be afrezza users for life. Mike is going to hit the endos early and hard in preparing for the kids. No one wants kids getting hypos, especially their moms. Aged - have you ever dealt with "soccer moms"? I have and I think moms of T1s have a greater passion. Nice to know Mike was learning on the job considering the reason he was originally hired was because he was meant to be an expert in this area. CGMs have been of age for years. A Type 1 can relatively easily get a CGM and that has been the case for at least the seven or eight years and every endo has had experience of them for a lot longer. The take up is still limited and you have to ask why (this is aside from people who have CGMs but seldom use them). The last big barrier was Medicare, and that went two years ago. The uptake in CGMs is going to be driven by integration into pumps, and that is not to Mannkind's advantage. The large T1 study I think you mean is the analysis of the Affinity-1 data from six years ago. That is not going to move the needle, plus the data is not exactly earth moving. I doubt you are going to get many endos looking at that and deciding now is the time to start moving stable patients onto a new regime. If you want that move you need compelling data - STAT-2! I was curious what had changed in the SoC between this year and last year. Turns out the wording on hypos is exactly the same so no change there then. Notice (because doctors will) that it says may reduce, not does or will reduce. That is going to be enough to get it disregarded for pro-active change. The SOC will not change without a large scale trial, that's just the way it is. I definitely think there is an age range where pediatric uptake will be big. Aged - I am at a loss for words when I read "CGMs have been of age for years". My O' My! Weren't you the guy who argued CGMs would never be mainstream for a long long time just a few short years ago? Or, maybe you are a different Aged, not sure? As for Mike being originally hired because he was an expert in this area that couldn't be further from the truth. Mike got hired IMO because he had a set of stainless steel balls and contacted Matt and Al when Duanne DeSisto didn't show up for work. My understanding is they gave him a trial year as the Chief Marketing Officer. When I first met Mike he was like a deer in the headlights. He knew little of the diabetes market. At the same time that was over three years ago and Mike is a really smart guy. More important he does not have brass balls but rather SS balls which MNKD needed to save it from Receivership. As far as the SoC are you saying the hypo and BG control language are no change from last year? Why are some on this board saying its new wording. I don't remember it but I did not compare 2019 SoC to 2020 changes. Is it really true these same words were there last year? If so why was this thread started? At the same time they are very powerful words for the new sales reps to provide endos the reason to use afrezza, less hypos and better control. Prior all they had was statistically non-inferior and inhaled but maybe not as good A1c.
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Post by agedhippie on Jan 8, 2020 21:16:53 GMT -5
Aged - I am at a loss for words when I read "CGMs have been of age for years". My O' My! Weren't you the guy who argued CGMs would never be mainstream for a long long time just a few short years ago? Or, maybe you are a different Aged, not sure? As for Mike being originally hired because he was an expert in this area that couldn't be further from the truth. Mike got hired IMO because he had a set of stainless steel balls and contacted Matt and Al when Duanne DeSisto didn't show up for work. My understanding is they gave him a trial year as the Chief Marketing Officer. When I first met Mike he was like a deer in the headlights. He knew little of the diabetes market. At the same time that was over three years ago and Mike is a really smart guy. More important he does not have brass balls but rather SS balls which MNKD needed to save it from Receivership. As far as the SoC are you saying the hypo and BG control language are no change from last year? Why are some on this board saying its new wording. I don't remember it but I did not compare 2019 SoC to 2020 changes. Is it really true these same words were there last year? If so why was this thread started? At the same time they are very powerful words for the new sales reps to provide endos the reason to use afrezza, less hypos and better control. Prior all they had was statistically non-inferior and inhaled but maybe not as good A1c. In what way is a product being available and that product not being mainstream mutual contradictory? So yes I am saying that CGMs have been out for a long time, but they will not be mainstream for a long time. I got my Dexcom Seven Plus ten years ago (still have it somewhere!) so I think that qualifies as having been available for a long time. How are we doing for mainstream? In the US about 840,000 out of around 30 million diabetics have a CGM - that's less than 3%. My bet would be that this is almost entirely in the 10% of diabetics who are Type 1 which marries up to the idea that around 30% of Type 1s have a CGM. CGMs will go mainstream, but the insurers are going to delay that as long as humanly possible. The end-run would be to reduce the costs of CGMs to the point where insurance no longer matters, but that is not any time soon from what we can see over the next couple of years. Mike was hired because he knew how to market drugs. How is that going? "...If so why was the thread started?" Did you read the first post that I opened this thread with? If so you will see the thread was started to announce the arrival of the 2020 SoC. Why are some on this board saying the wording is new? Maybe for the same reason I wondered - they didn't put the two versions side by side. Well I have done that now and they are identical barring the removal of some sub-headings. The reps are going to have the same wording as previously to work with.
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Post by sellhighdrinklow on Jan 8, 2020 22:18:38 GMT -5
Aged - I am at a loss for words when I read "CGMs have been of age for years". My O' My! Weren't you the guy who argued CGMs would never be mainstream for a long long time just a few short years ago? Or, maybe you are a different Aged, not sure? As for Mike being originally hired because he was an expert in this area that couldn't be further from the truth. Mike got hired IMO because he had a set of stainless steel balls and contacted Matt and Al when Duanne DeSisto didn't show up for work. My understanding is they gave him a trial year as the Chief Marketing Officer. When I first met Mike he was like a deer in the headlights. He knew little of the diabetes market. At the same time that was over three years ago and Mike is a really smart guy. More important he does not have brass balls but rather SS balls which MNKD needed to save it from Receivership. As far as the SoC are you saying the hypo and BG control language are no change from last year? Why are some on this board saying its new wording. I don't remember it but I did not compare 2019 SoC to 2020 changes. Is it really true these same words were there last year? If so why was this thread started? At the same time they are very powerful words for the new sales reps to provide endos the reason to use afrezza, less hypos and better control. Prior all they had was statistically non-inferior and inhaled but maybe not as good A1c. In what way is a product being available and that product not being mainstream mutual contradictory? So yes I am saying that CGMs have been out for a long time, but they will not be mainstream for a long time. I got my Dexcom Seven Plus ten years ago (still have it somewhere!) so I think that qualifies as having been available for a long time. How are we doing for mainstream? In the US about 840,000 out of around 30 million diabetics have a CGM - that's less than 3%. My bet would be that this is almost entirely in the 10% of diabetics who are Type 1 which marries up to the idea that around 30% of Type 1s have a CGM. CGMs will go mainstream, but the insurers are going to delay that as long as humanly possible. The end-run would be to reduce the costs of CGMs to the point where insurance no longer matters, but that is not any time soon from what we can see over the next couple of years. Mike was hired because he knew how to market drugs. How is that going? "...If so why was the thread started?" Did you read the first post that I opened this thread with? If so you will see the thread was started to announce the arrival of the 2020 SoC. Why are some on this board saying the wording is new? Maybe for the same reason I wondered - they didn't put the two versions side by side. Well I have done that now and they are identical barring the removal of some sub-headings. The reps are going to have the same wording as previously to work with. When the Dexcom 7+ was out, DXCM stock was trading at $4. Keep spinning your spin Hippie. Your transparency is what it is.
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Post by shawnonafrezza on Jan 8, 2020 22:21:02 GMT -5
This from an ALLEGED type 1, who prefers to be tethered to a pump and who enjoys a 6.3 A1C (diabetic defined) rather than even trying Afrezza to experience what a normal A1C feels like. AKA a normal life. Shawnflynn calls me a "dick" for knocking Agedhippie for his choice on "managing his blood sugar levels". YET, Mr or Ms. Hippie is on this board pontificating negativity of Afrezza many times each day. If folks believe Hippie is actually here to do something other than spread FUD, you might want to take a second to rethink. And yes, Shawnflynn can call my comments a " dick move" all he or she wants, because being tethered to a pump at 6.3 vs no tether and a 5.3 defies logic. Aged is MDI. FYI.
And you beat me to it. Like I said, if we want to measure dicks by A1C...
That was pre Afrezza, that on a pump some 7 months ago. I don't have my hardcore GRIT days but that was with R and I got in the 4s. My next labs are Wednesday and Clarity is estimating 5.5. On Afrezza though... It's almost like it's not just the insulin or method of deliver you use that matters.
You are more than your A1C. You are more than your treatment decisions. You are more than your diabetes. You are more than your dietary decisions. You are more than your highs and lows.
Empathy goes a long way.
Just an update since I said I was getting labs and this is what would be possible with a different soc...
Tresiba + R + Afrezza
This was not expected at all. Dexcom estimated much higher.
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Post by sellhighdrinklow on Jan 8, 2020 22:25:46 GMT -5
My home test today came in at 4.9.
Long live Afrezza and for me, Lantus.
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Post by agedhippie on Jan 8, 2020 22:45:02 GMT -5
In what way is a product being available and that product not being mainstream mutual contradictory? So yes I am saying that CGMs have been out for a long time, but they will not be mainstream for a long time. I got my Dexcom Seven Plus ten years ago (still have it somewhere!) so I think that qualifies as having been available for a long time. How are we doing for mainstream? In the US about 840,000 out of around 30 million diabetics have a CGM - that's less than 3%. My bet would be that this is almost entirely in the 10% of diabetics who are Type 1 which marries up to the idea that around 30% of Type 1s have a CGM. CGMs will go mainstream, but the insurers are going to delay that as long as humanly possible. The end-run would be to reduce the costs of CGMs to the point where insurance no longer matters, but that is not any time soon from what we can see over the next couple of years. Mike was hired because he knew how to market drugs. How is that going? "...If so why was the thread started?" Did you read the first post that I opened this thread with? If so you will see the thread was started to announce the arrival of the 2020 SoC. Why are some on this board saying the wording is new? Maybe for the same reason I wondered - they didn't put the two versions side by side. Well I have done that now and they are identical barring the removal of some sub-headings. The reps are going to have the same wording as previously to work with. When the Dexcom 7+ was out, DXCM stock was trading at $4. Keep spinning your spin Hippie. Your transparency is what it is. Yes, 10 years ago the Dexcom share price was $4. I am not sure what that has to do with how long Dexcom CGMs have been available.
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Post by lennymnkd on Jan 8, 2020 22:53:20 GMT -5
But the share price certainly has to do with market acceptance.
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Post by agedhippie on Jan 9, 2020 4:26:51 GMT -5
But the share price certainly has to do with market acceptance. That would be stock market rather than customer market. The stock market often accepts (or not) a lot faster than the customers. Hence the old adage of "buy on rumor, sell on news".
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Post by sayhey24 on Jan 9, 2020 6:38:17 GMT -5
Aged - I am at a loss for words when I read "CGMs have been of age for years". My O' My! Weren't you the guy who argued CGMs would never be mainstream for a long long time just a few short years ago? Or, maybe you are a different Aged, not sure? As for Mike being originally hired because he was an expert in this area that couldn't be further from the truth. Mike got hired IMO because he had a set of stainless steel balls and contacted Matt and Al when Duanne DeSisto didn't show up for work. My understanding is they gave him a trial year as the Chief Marketing Officer. When I first met Mike he was like a deer in the headlights. He knew little of the diabetes market. At the same time that was over three years ago and Mike is a really smart guy. More important he does not have brass balls but rather SS balls which MNKD needed to save it from Receivership. As far as the SoC are you saying the hypo and BG control language are no change from last year? Why are some on this board saying its new wording. I don't remember it but I did not compare 2019 SoC to 2020 changes. Is it really true these same words were there last year? If so why was this thread started? At the same time they are very powerful words for the new sales reps to provide endos the reason to use afrezza, less hypos and better control. Prior all they had was statistically non-inferior and inhaled but maybe not as good A1c. In what way is a product being available and that product not being mainstream mutual contradictory? So yes I am saying that CGMs have been out for a long time, but they will not be mainstream for a long time. I got my Dexcom Seven Plus ten years ago (still have it somewhere!) so I think that qualifies as having been available for a long time. How are we doing for mainstream? In the US about 840,000 out of around 30 million diabetics have a CGM - that's less than 3%. My bet would be that this is almost entirely in the 10% of diabetics who are Type 1 which marries up to the idea that around 30% of Type 1s have a CGM. CGMs will go mainstream, but the insurers are going to delay that as long as humanly possible. The end-run would be to reduce the costs of CGMs to the point where insurance no longer matters, but that is not any time soon from what we can see over the next couple of years. Mike was hired because he knew how to market drugs. How is that going? "...If so why was the thread started?" Did you read the first post that I opened this thread with? If so you will see the thread was started to announce the arrival of the 2020 SoC. Why are some on this board saying the wording is new? Maybe for the same reason I wondered - they didn't put the , two versions side by side. Well I have done that now and they are identical barring the removal of some sub-headings. The reps are going to have the same wording as previously to work with. Aged - The words in the SoC are very powerful. Combined with the Affinity-1 analysis and the STAT Mike's reps can now give the endo's the reason to use afrezza with T1s; better control; less hypos. As you have said the reps could not market off-label until as I think most here now realize until study data was available which support these positions in the SoC. investors.mannkindcorp.com/news-releases/news-release-details/study-171-shows-hypoglycemia-reduced-use-afrezzar-relativeMike has told us his 2020 target - T1 endos; and Mike now has no excuses for not executing. If Mike's reps can not sell the holy grail of diabetes care to endos now that they can tell the endos why they need to be using it, then I will join the threads asking for Mike's head. I am hoping 2020 is the beginning of something great for MNKD.
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