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Post by lennymnkd on Jan 7, 2020 7:34:16 GMT -5
Can CGM’s get to the price point that they are given away with a package commitment to AFREZZA like a lot of things in technology today....
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Post by prcgorman2 on Jan 7, 2020 7:38:46 GMT -5
Here's hoping M C is reading this and takes heed. Huevos? Cajones? Bullocks? Cobblers? MC, take your pick, but pick a pair!!! I’m going to guess you don’t have a JD in your professional title. I work with several regulatory attorneys. No CEO worth spit is going to knowingly put his company at risk of public conflict with a federal regulatory agency without professional counsel. If there are any JDs with FDA expertise watching this board, it would be good to get their view(s) before assuming Dr. Castagna should just damn the torpedoes. I certainly do not make that assumption although I certainly hope their views align with yours. It would be very good to have the shackles removed.
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Post by agedhippie on Jan 7, 2020 9:23:55 GMT -5
That would certainly be a good lead given that it seems it can be done. The counter-argument will be that there are a lot of ways to reduce hypos; use of CGMs is one, augmented pumps like the Tandem Control IQ or the Medtronics 670G is another. Since we are talking about the Type 1 market now given Mike's targeting comments both of those are probably already in use, or an easy insurance sell in the case of the 670G (they have a deal with insurers where Medtronics rebates any ER costs for their pump users). What the endos will be looking for is the biggest impact for the smallest disruption to current practice. That said; lower hypo rate will always get attention but they are going to want to drill down into the data. Aged - Counter-argument, really??? Adding CGMs to afrezza use is not a counter-argument. The use of CGMs with afrezza is synergistic. They work hand in hand. For T1s CGMs and afrezza should be the hands-down standard prior to any RAA use. One thing we do know by looking at the CGM post meal is afrezza can stop the spike and RAA's not so much. We also know by looking at the CGM is if you are runnning high nothing brings down BG for the T1 faster than afrezza. I would be hoping MNKD is developing very strong relationships with the three leading CGM providers. In fact Kevin Sayer was on Al Mann's team when afrezza was invented and my favorite Kevin Sayer quote is when he was asked about afrezza to which he responded he has "never seen anything like it". Absolutely counter-argument. If you don't think about the other side of the argument then don't be surprised when it bites you. Frankly any insulin and a CGM is synergistic, that's what that paper in the January Diabetes Care was saying - use a CGM and you can achieve a low A1c with no increased risk of hypos, and that's with RAA. There is synergy between the CGM and the pump in the hybrid pumps that are the current standard (Omnipod aside) and that achieve better TIR than a CGM and Afrezza (see the STAT study, and the Tandem Control IQ and Medtronics 670G trials). Yes, Afrezza will correct a high very fast, but personally I don't care if it is corrected half an hour faster or not. The killer for me though is the need for the second dose. That is not going to fly with the majority of people so adjust your expectations for that result. That is not to say that people will not take Afrezza, they absolutely will, just that they are unlikely to take the follow up dose. We know this because it's what you are told to do today with RAA and nobody does it which is nothing to do with fear of insulin stacking and everything to do with having a life. People want options, there are still people who are using animal insulins from choice! I would never advise that if asked, but I would equally never criticize them for doing that. What does a strong relationship with CGM providers look like? Genuinely curious. Bear in mind that the overwhelming percentage of their customers use RAA, and a growing percentage of their revenue is coming from pump integrations.
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Post by agedhippie on Jan 7, 2020 9:34:48 GMT -5
Can CGM’s get to the price point that they are given away with a package commitment to AFREZZA like a lot of things in technology today.... Today it may be possible to package a low cost CGM like the Libre, but although CGM prices will drop insulin prices will drop faster. In the end there is probably not going to be the margin to support it. The added complication is that CGMs are prescription devices (I have no idea why since meters are not).
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Post by casualinvestor on Jan 7, 2020 9:54:10 GMT -5
Yes, Afrezza will correct a high very fast, but personally I don't care if it is corrected half an hour faster or not. The killer for me though is the need for the second dose. That is not going to fly with the majority of people so adjust your expectations for that result. That is not to say that people will not take Afrezza, they absolutely will, just that they are unlikely to take the follow up dose. We know this because it's what you are told to do today with RAA and nobody does it which is nothing to do with fear of insulin stacking and everything to do with having a life. The thing is, you are ignoring the difference between a long inhale and having to inject. How big that difference is going to change from person to person, or even where you happen to be (injections are a lot easier if you happen to be at home when you need one). Injections are a part of the barrier to taking that followup. Inhaling will be less so, although other reasons may still get in the way.
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Post by matt on Jan 7, 2020 9:55:25 GMT -5
What does a strong relationship with CGM providers look like? Genuinely curious. Bear in mind that the overwhelming percentage of their customers use RAA, and a growing percentage of their revenue is coming from pump integrations. Having been in healthcare for more than 40 years, well before Medicare adopted DRGs and upset the entire structure of health insurance, I take a pretty cynical view of phrases like "strong relationship". Every company has an obligation to its shareholders, and the only shareholders a CGM company will truly care about are its own. There are lots of marketing initiatives where the partners march out promotional materials that make it sound like two companies are like Siamese twins joined at the hip, but many of those relationships only last until next quarter's financial results come in. The only true relationships are those that make continuing economic sense for both sides such as one in which a manufacturer cannot reach a group of customers without help from a specialty distributor and the distributor can make an above average profit margin introducing the manufacturer's product. Otherwise, it is like being the most beautiful girl at the dance; everybody wants to be with you until an even more beautiful lady shows up at which point the former number one is relegated to standing alone in the corner. CGM companies are device manufacturers that could care less about which insulin product the patient uses. They want to sell electronics and they will gladly "partner" with any insulin manufacturer that will co-promote their CGM, but they will always prefer Lilly and Novo Nordisk over Mannkind simply because that is where the market share is to be found. If Afrezza can start bringing in the same volume as Lilly and Novo (they account for roughly 125,000 scripts each every week vs 1,000 scripts for Mannkind), then the CGM companies will line up at corporate headquarters offering to partner. Until then, for the CGM producers the grass is greener elsewhere. It is not personal, it is just economic reality.
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Post by lennymnkd on Jan 7, 2020 9:57:40 GMT -5
There's not a premium with the synergies (insulin) and CGM THAT would make up the difference
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Post by mango on Jan 7, 2020 10:01:01 GMT -5
Aged - Counter-argument, really??? Adding CGMs to afrezza use is not a counter-argument. The use of CGMs with afrezza is synergistic. They work hand in hand. For T1s CGMs and afrezza should be the hands-down standard prior to any RAA use. One thing we do know by looking at the CGM post meal is afrezza can stop the spike and RAA's not so much. We also know by looking at the CGM is if you are runnning high nothing brings down BG for the T1 faster than afrezza. I would be hoping MNKD is developing very strong relationships with the three leading CGM providers. In fact Kevin Sayer was on Al Mann's team when afrezza was invented and my favorite Kevin Sayer quote is when he was asked about afrezza to which he responded he has "never seen anything like it". Absolutely counter-argument. If you don't think about the other side of the argument then don't be surprised when it bites you. Frankly any insulin and a CGM is synergistic, that's what that paper in the January Diabetes Care was saying - use a CGM and you can achieve a low A1c with no increased risk of hypos, and that's with RAA. There is synergy between the CGM and the pump in the hybrid pumps that are the current standard (Omnipod aside) and that achieve better TIR than a CGM and Afrezza (see the STAT study, and the Tandem Control IQ and Medtronics 670G trials). Yes, Afrezza will correct a high very fast, but personally I don't care if it is corrected half an hour faster or not. The killer for me though is the need for the second dose. That is not going to fly with the majority of people so adjust your expectations for that result. That is not to say that people will not take Afrezza, they absolutely will, just that they are unlikely to take the follow up dose. We know this because it's what you are told to do today with RAA and nobody does it which is nothing to do with fear of insulin stacking and everything to do with having a life. People want options, there are still people who are using animal insulins from choice! I would never advise that if asked, but I would equally never criticize them for doing that. What does a strong relationship with CGM providers look like? Genuinely curious. Bear in mind that the overwhelming percentage of their customers use RAA, and a growing percentage of their revenue is coming from pump integrations. While I do agree with you that any insulin + a CGM will produce synergy, obviously the therapeutic potential is not the same across the board—Afrezza + CGM = Gold Standard. In response to the bold—it is not wise to make assumptions, and the burden that holds true for RAAs remains to be seen with Afrezza. Taking a second dose of Afrezza is not even in the same reality as administering a followup injection of insulin. Afrezza is painless, takes hardly any time to administer, does not require strict carb counting, and is incredibly safe. Put simply, there is no burden with a followup dose of Afrezza (currently/factually), yet there is with a followup injection of RAA.
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Post by sellhighdrinklow on Jan 7, 2020 10:08:16 GMT -5
Aged - Counter-argument, really??? Adding CGMs to afrezza use is not a counter-argument. The use of CGMs with afrezza is synergistic. They work hand in hand. For T1s CGMs and afrezza should be the hands-down standard prior to any RAA use. One thing we do know by looking at the CGM post meal is afrezza can stop the spike and RAA's not so much. We also know by looking at the CGM is if you are runnning high nothing brings down BG for the T1 faster than afrezza. I would be hoping MNKD is developing very strong relationships with the three leading CGM providers. In fact Kevin Sayer was on Al Mann's team when afrezza was invented and my favorite Kevin Sayer quote is when he was asked about afrezza to which he responded he has "never seen anything like it". Absolutely counter-argument. If you don't think about the other side of the argument then don't be surprised when it bites you. Frankly any insulin and a CGM is synergistic, that's what that paper in the January Diabetes Care was saying - use a CGM and you can achieve a low A1c with no increased risk of hypos, and that's with RAA. There is synergy between the CGM and the pump in the hybrid pumps that are the current standard (Omnipod aside) and that achieve better TIR than a CGM and Afrezza (see the STAT study, and the Tandem Control IQ and Medtronics 670G trials). Yes, Afrezza will correct a high very fast, but personally I don't care if it is corrected half an hour faster or not. The killer for me though is the need for the second dose. That is not going to fly with the majority of people so adjust your expectations for that result. That is not to say that people will not take Afrezza, they absolutely will, just that they are unlikely to take the follow up dose. We know this because it's what you are told to do today with RAA and nobody does it which is nothing to do with fear of insulin stacking and everything to do with having a life. People want options, there are still people who are using animal insulins from choice! I would never advise that if asked, but I would equally never criticize them for doing that. What does a strong relationship with CGM providers look like? Genuinely curious. Bear in mind that the overwhelming percentage of their customers use RAA, and a growing percentage of their revenue is coming from pump integrations. 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.
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Post by sportsrancho on Jan 7, 2020 10:09:48 GMT -5
SENS doesn’t seem to have many options either.. Why don’t the two underdogs get together?
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Post by shawnonafrezza on Jan 7, 2020 11:24:51 GMT -5
Absolutely counter-argument. If you don't think about the other side of the argument then don't be surprised when it bites you. Frankly any insulin and a CGM is synergistic, that's what that paper in the January Diabetes Care was saying - use a CGM and you can achieve a low A1c with no increased risk of hypos, and that's with RAA. There is synergy between the CGM and the pump in the hybrid pumps that are the current standard (Omnipod aside) and that achieve better TIR than a CGM and Afrezza (see the STAT study, and the Tandem Control IQ and Medtronics 670G trials). Yes, Afrezza will correct a high very fast, but personally I don't care if it is corrected half an hour faster or not. The killer for me though is the need for the second dose. That is not going to fly with the majority of people so adjust your expectations for that result. That is not to say that people will not take Afrezza, they absolutely will, just that they are unlikely to take the follow up dose. We know this because it's what you are told to do today with RAA and nobody does it which is nothing to do with fear of insulin stacking and everything to do with having a life. People want options, there are still people who are using animal insulins from choice! I would never advise that if asked, but I would equally never criticize them for doing that. What does a strong relationship with CGM providers look like? Genuinely curious. Bear in mind that the overwhelming percentage of their customers use RAA, and a growing percentage of their revenue is coming from pump integrations. 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.
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Post by peppy on Jan 7, 2020 12:00:12 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.
We love our board diabetics. They tell us. SellHighDrinkLow is also a board diabetic. Type one. SellHighDrikLow seldom talks about his diabetes. I do not believe I am confused. MDI? www.urbandictionary.com/define.php?term=MDI
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Post by ktim on Jan 7, 2020 12:06:08 GMT -5
Here's hoping M C is reading this and takes heed. Huevos? Cajones? Bullocks? Cobblers? MC, take your pick, but pick a pair!!! Pick a fight with the FDA as Al did?
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Post by shawnonafrezza on Jan 7, 2020 12:28:20 GMT -5
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.
We love our board diabetics. They tell us. SellHighDrinkLow is also a board diabetic. Type one. SellHighDrikLow seldom talks about his diabetes. I do not believe I am confused. MDI? www.urbandictionary.com/define.php?term=MDIMDI = Multiple Daily Injections. Shots.
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Post by brotherm1 on Jan 7, 2020 14:01:23 GMT -5
So, for those that were familiar with the prior SOC, does this new one show anything new and more positive for Aftezza that should help with sales/insurance?
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