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Post by uvula on Jun 16, 2018 23:41:47 GMT -5
No one here seems to take artificial pancreas closed loop pumps seriously but they could be real competition. (Yes, I know that can't respond as fast as Afrezza but they might be good enough for the masses that want a low effort solution.)
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Post by thekindaguyiyam on Jun 17, 2018 0:21:08 GMT -5
Good thing we have the Pros to counter the Cons Most of the Con Men & Women seem to be in the swamp in DC. Let’s focus on Making Mannkind Great again. It was Great when Alfred brought it to market. It remains Superior Now and Great Now. It's time for ADA to reveal to the skeptics that there is no magic trick; that this is the real thing. Mannkind/ Affrezza is on the right track. Afrezza isn't about politics. It the intelligent bipartisan choice.
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Post by agedhippie on Jun 17, 2018 9:36:44 GMT -5
No one here seems to take artificial pancreas closed loop pumps seriously but they could be real competition. (Yes, I know that can't respond as fast as Afrezza but they might be good enough for the masses that want a low effort solution.) I think they will be, but only for a segment of the market. If they have a pump today then they are a prime target for an artificial pancreas. Outside that group, which is the majority, I think that the AP will struggle because insurers are not going to want to pay (or people don't want an external device). The biggest competitor is going to be the status quo. For the most part there is little immediate observable down side to spikes and higher levels so there is a tendency to ignore them. I know the reply is that this will change when CGMs are broadly available, but I doubt it. You tend to tune them out in favor of more immediate things. As an example when I use a CGM I set the high high alert really high because short of a medical emergency I do not want to be interrupted (I leave the hypo alert in place because I care about that). If I am working and I hit 140 I am not about to stop and deal with it, I am going to ignore it and clean things up later. Some people are more driven, but an awful lot are not.
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Post by sportsrancho on Jun 17, 2018 9:49:39 GMT -5
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Post by agedhippie on Jun 17, 2018 10:02:37 GMT -5
Ok - I admit if my A1c was over 10 I would definitely care more as well. I think maybe it comes down to what each person sees as trying, and what the trade off is. I am luck, I don't try much and my A1c hovers around 7, mostly under, and when I use a CGM my TIR is around 75% (deviations tend to the upside) with a low standard deviation which is good (I target SD more than TIR). On the other hand I know people who work really hard and still end up in the 8s and 9s. It's a bit of a lottery.
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Post by akemp3000 on Jun 17, 2018 10:13:21 GMT -5
Ok - I admit if my A1c was over 10 I would definitely care more as well. I think maybe it comes down to what each person sees as trying, and what the trade off is. I am luck, I don't try much and my A1c hovers around 7, mostly under, and when I use a CGM my TIR is around 75% (deviations tend to the upside) with a low standard deviation which is good (I target SD more than TIR). On the other hand I know people who work really hard and still end up in the 8s and 9s. It's a bit of a lottery. They should not participate in a lottery. Please tell them about and convince them that Afrezza will not only improve their daily lives but will extend as well.
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Post by agedhippie on Jun 17, 2018 14:31:40 GMT -5
Ok - I admit if my A1c was over 10 I would definitely care more as well. I think maybe it comes down to what each person sees as trying, and what the trade off is. I am luck, I don't try much and my A1c hovers around 7, mostly under, and when I use a CGM my TIR is around 75% (deviations tend to the upside) with a low standard deviation which is good (I target SD more than TIR). On the other hand I know people who work really hard and still end up in the 8s and 9s. It's a bit of a lottery. They should not participate in a lottery. Please tell them about and convince them that Afrezza will not only improve their daily lives but will extend as well. Trust me, I have tried. There is a limit to how hard you can push though.
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Post by oldfishtowner on Jun 17, 2018 15:30:34 GMT -5
As we approach the start of ADA (at roughly the midpoint of 2018) I thought it might be good to recap what we have to look forward to this year both pro and con: A. The Pros 1. ADA Stat Study and Hypo Study 2. Term sheet (possibly China?) 3. Possible second term sheet (Mexico or Canada?) 4. Trep T Partner (upfront cash payment?) 5. One Drop partnership for direct pay subscription 6. Better Insurance Coverage 7. Gradual trend of increasing scripts and revenue 8. Mike’s assurances we will meet guidance 9. RLS, anyone??? 10. Approval of AFREZZA for Brazil 11. Possible Fast track of AFREZZA in India 12. Start of Trep T Phase 3 13. Reduction of Deerfield Debt w final payment in 2019, leaving only Mann Group as a major debtor 14. New Commercial and more commercials 15. Dr. K continued publishing and outreach w his advisory board 16. Continued growth of cgm penetration and with it the growth of importance of TIR, which helps us B. The Cons 1. Need for cash: Dilution on it before August? Or something non-dilutive? Likely dilution 2. Payment to Deerfield in July with stock also dilutive 3. Scripts and revenue do not grow as expected 4. Dilution in 1st Q 2019 I would say the Pros outweigh the The Cons imho at this point in time. Please note if I have left anything out either Pro or Con please feel free to add. This is only meant to be an outline to start a conversation about what we might expect over next six months until end of year. Also I have only included those items both pro and con which imho are real possibilities and have tried to avoid the truly speculative with no basis or reference points making them worth inclusion on either list. Items 4 & 12 may not happen this year, but maybe 1st quarter and 2nd quarter 2019 respectively. The PR released on the completion of the phase 1 trial stated, "Based on these data, MannKind is preparing the next phase of development to evaluate the safety and tolerability of TreT in patients with PAH." This next "phase of development" sounds to me like another phase 1 trial, this time in PAH patients rather than healthy subjects. If this is so, the phase 1 studies may not complete until November or December, which likely means that a partnership deal might not materialize until 1st or 2nd quarter next year, with the phase 3 study following (unless MNKD decides to fully fund the phase 3 trial itself.)
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Post by Deleted on Jun 17, 2018 16:16:12 GMT -5
No one here seems to take artificial pancreas closed loop pumps seriously but they could be real competition. (Yes, I know that can't respond as fast as Afrezza but they might be good enough for the masses that want a low effort solution.) I think they will be, but only for a segment of the market. If they have a pump today then they are a prime target for an artificial pancreas. Outside that group, which is the majority, I think that the AP will struggle because insurers are not going to want to pay (or people don't want an external device). The biggest competitor is going to be the status quo. For the most part there is little immediate observable down side to spikes and higher levels so there is a tendency to ignore them. I know the reply is that this will change when CGMs are broadly available, but I doubt it. You tend to tune them out in favor of more immediate things. As an example when I use a CGM I set the high high alert really high because short of a medical emergency I do not want to be interrupted (I leave the hypo alert in place because I care about that). If I am working and I hit 140 I am not about to stop and deal with it, I am going to ignore it and clean things up later. Some people are more driven, but an awful lot are not. Small % of diabetic ppn is target for AP and given its pretty advanced stuff, may not work as well (initially as had hoped). Like CGMs, at the beginning, not so good but today, very good. Takes time and money to improve the iterations. Sam can't be the only one who has ditched the pump in favor of Afrezza and basal. Far easier and much less expensive and its not like our debt is getting smaller and with the massive increase in diabetes and pre-diabetes, pumps ain't good for anyone's budget. What do they cost now, $7500 or so? With CGM, A1C is a buggy whip. Would not be surprised if Amazon/JMP/Buffet pursues diabetes since the costs of the disease and associated complications could be large enough to take down the US healthcare system. Hate to use buzzwords but diabetes is beyond ready for disruption. Time in range = better health = lower costs. H2 will be interesting to say the least. Afrezza sales growing at a rate 30% faster than the last year or so could put some nice upward pressure on SP. That said, the product cannot continue at current growth rate in the US or perhaps some other countries get it on market sooner than expected. For pediatric trial, it was the FDA some time ago that wanted Afrezza tested in kids down to 4 yrs old and thats when the chatter for a 2U dose surfaced.
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Post by slugworth008 on Jun 17, 2018 16:30:40 GMT -5
I second that!! And speculate.... #1...That after we are in a position of strength we could get a co/partner for Afrezza. #2...That RLS is hooey. RLS is definitely hooey - IMO - was a brilliant smokescreen by the previous administration IMO
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Post by nylefty on Jun 17, 2018 17:12:53 GMT -5
So Andrea Leone-Bay has been involved in "hooey" all this time? Really?
And the million bucks Mannkind received from RLS, while not much in the overall scheme of things, was also hooey?
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Post by sportsrancho on Jun 17, 2018 17:17:01 GMT -5
I second that!! And speculate.... #1...That after we are in a position of strength we could get a co/partner for Afrezza. #2...That RLS is hooey. RLS is definitely hooey - IMO - was a brilliant smokescreen by the previous administration IMO Slug, let’s add #3... The Wainwright article and downgrade was not a typo, they are history and we’re getting a new bank:-))
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Post by sweedee79 on Jun 17, 2018 18:33:55 GMT -5
Why SHOULD people with diabetes have to try so hard? Maybe they just want a normal life. Quality of life is important....
It isn't just quality of life.. but also a superior and appropriate treatment..
It seems to me that we have come to a point in this country where how rich you are dictates whether or not you get appropriate care.. I don't regard sub q as up to date or appropriate. I agree with Dr. Kendall.. it is barbaric..
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Post by agedhippie on Jun 17, 2018 18:48:48 GMT -5
I think they will be, but only for a segment of the market. If they have a pump today then they are a prime target for an artificial pancreas. Outside that group, which is the majority, I think that the AP will struggle because insurers are not going to want to pay (or people don't want an external device). The biggest competitor is going to be the status quo. For the most part there is little immediate observable down side to spikes and higher levels so there is a tendency to ignore them. I know the reply is that this will change when CGMs are broadly available, but I doubt it. You tend to tune them out in favor of more immediate things. As an example when I use a CGM I set the high high alert really high because short of a medical emergency I do not want to be interrupted (I leave the hypo alert in place because I care about that). If I am working and I hit 140 I am not about to stop and deal with it, I am going to ignore it and clean things up later. Some people are more driven, but an awful lot are not. Small % of diabetic ppn is target for AP and given its pretty advanced stuff, may not work as well (initially as had hoped). Like CGMs, at the beginning, not so good but today, very good. Takes time and money to improve the iterations. Sam can't be the only one who has ditched the pump in favor of Afrezza and basal. Far easier and much less expensive and its not like our debt is getting smaller and with the massive increase in diabetes and pre-diabetes, pumps ain't good for anyone's budget. What do they cost now, $7500 or so? With CGM, A1C is a buggy whip. Would not be surprised if Amazon/JMP/Buffet pursues diabetes since the costs of the disease and associated complications could be large enough to take down the US healthcare system. Hate to use buzzwords but diabetes is beyond ready for disruption. Time in range = better health = lower costs. H2 will be interesting to say the least. Afrezza sales growing at a rate 30% faster than the last year or so could put some nice upward pressure on SP. That said, the product cannot continue at current growth rate in the US or perhaps some other countries get it on market sooner than expected. For pediatric trial, it was the FDA some time ago that wanted Afrezza tested in kids down to 4 yrs old and thats when the chatter for a 2U dose surfaced. What I think you will see with the AP is that the AP becomes the default for pump users simply because all pumps will become APs or go out of business. This is already happening today, automatic basal suspend has been around for a couple of years now, and you are seeing the intermediate stage in the hybrid pumps like the Medtronics 670G and T:SlimX2 which go beyond basal suspend to predictive actions. If you get a pump today, this is what the endos are pushing and the insurers are paying for. The promise of the AP is good TIR with no manual intervention. That is absolutely a winner. I used a pump for a few years but in the end I decided that it wasn't worth it, the AP would get me back.
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Post by brotherm1 on Jun 17, 2018 19:06:06 GMT -5
So Andrea Leone-Bay has been involved in "hooey" all this time? Really? And the million bucks Mannkind received from RLS, while not much in the overall scheme of things, was also hooey? I got the impression last time or so that Mike spoke publicly about RLS to answer a question about it, it seamed to me he even kind of like tilted his head upward, rolled his eyes, shrugged his shoulders and threw his hands out out to his sides palms up and said something like who knows. Not really, but that’s the impression I got.
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