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Post by cjm18 on Jun 2, 2022 20:03:34 GMT -5
IMO, the biggest obstacle to Afrezza has been that all doctors are taught in med school to prescribe insulin ONLY as a last resort because it can cause hypos and death. These were my doctor's words. Afrezza offers a new and very different perspective that has not yet been sufficiently heard, understood or accepted by the mainstream. FDA approval for pediatrics should be a huge game changer because it would send a powerful message to doctors that Afrezza insulin is safe. It's hard to imagine any educated parent ever again choosing shots over inhalation for their child at mealtime. This would change everything and should become game on with the BPs. To be clear here. The competition in pediatrics is not shots, it's automated insulin delivery via a pump. The default action for new Type 1 diabetics is to immediately get them on a pump if their insurance covers it. These days the focus for kids is the automated delivery pumps. True true about pumps. Thus mannkind chose the Abc trial Years ago someone posted on here that their endo or physician friend said Afrezza was never going to catch on until peds. Then mannkind pivoted to type I. Then the abc and peds trial. Then the v go (60% Medicare). Mannkind is going in the right direction wiht peds. Outside of new partnerships or 2nd molecule with United I don’t see any major catalysts over the next 6 months. Everything is based on tyvaso sales right now. |
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Post by solicurance on Jun 2, 2022 21:25:57 GMT -5
Perfect study UTHR… with good results, I feel that will be a decent catalyst
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Post by Deleted on Jun 2, 2022 21:39:54 GMT -5
Casper - what am I missing? Why do the T2s take oral meds? And then, why do they take GLP1s ($11B sales) and SGLT2s ($7B). I would argue because the SoC says so and their doctor is following the SoC. The T2 is pretty much going to do what they are told by their doctor. Its really that simple. ... They take oral meds because it's easy and until TIR becomes the standard it appears effective. Given the choice between one injection a week and one of two inhales every time they eat it's never even going to be a contest. From a compliance standpoint the fewer doses the better - once a day is good, once a week is better, three to six times a day is not good. Compliance in chronic diseases with little obvious penalty for non-compliance has historically been awful. AND Oral Meds are CHEAP and doctors consider the patients finances when prescribing meds. |
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Post by sayhey24 on Jun 3, 2022 5:25:09 GMT -5
Casper - what am I missing? Why do the T2s take oral meds? And then, why do they take GLP1s ($11B sales) and SGLT2s ($7B). I would argue because the SoC says so and their doctor is following the SoC. The T2 is pretty much going to do what they are told by their doctor. Its really that simple. ... They take oral meds because it's easy and until TIR becomes the standard it appears effective. Given the choice between one injection a week and one of two inhales every time they eat it's never even going to be a contest. From a compliance standpoint the fewer doses the better - once a day is good, once a week is better, three to six times a day is not good. Compliance in chronic diseases with little obvious penalty for non-compliance has historically been awful. Aged - Come on Man! We will clearly agree to disagree on this one. They take oral meds because that is what their doctors tell them to do. When it comes time to take insulin, they take the shot because that's what their doctor tells them to do. Now, how many oral meds are they taking? One, two, three and some even are taking the shot on top of this. What a mess. Is taking an oral med easier than orally inhaling afrezza at meal time? Its clearly not. At meal time they need to pick up a fork. Nearly all would also pick up a Dreamboat. Could we argue afrezza is an oral med? If it helps with marketing I could make that arguement. Dave Kendall told us the problem with getting T2s to take afrezza. Sometimes its worth listening to the ex-Chief Medical Officer at the ADA. If afrezza was Step 2 in the ADA SoC it would be doing $5B+ in sales right now, probably more. For afrezza to begin the SoC path requires a follow-on Affinty-2 trial head to head with Mounjaro. Properly dosed afrezza will crush Mounjaro's A1c just as afrezza beat on A1c in the Affinty2. There is no need to wait for TIR. The next step is a partnership which has some real horsepower in doing the trial. |
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Post by sayhey24 on Jun 3, 2022 5:37:01 GMT -5
They take oral meds because it's easy and until TIR becomes the standard it appears effective. Given the choice between one injection a week and one of two inhales every time they eat it's never even going to be a contest. From a compliance standpoint the fewer doses the better - once a day is good, once a week is better, three to six times a day is not good. Compliance in chronic diseases with little obvious penalty for non-compliance has historically been awful. AND Oral Meds are CHEAP and doctors consider the patients finances when prescribing meds. Oral meds are cheap? Which oral med - metformin and then what? You think GLP1s and SGLT2s are cheap? GLP1s are doing about $11B in sales and SGLT2s about $7B. If that's cheap, I will take some of that cheap. We all know what the "Father of Metformin" nows says about metformin “The most waste in type 2 diabetes is to continuously put people on metformin and sulfonylureas (glyburide, glimepiride, etc.). These drugs have no protective effect on the beta cell, and by the time you figure out what you’re doing, there are no beta cells left to save.” – Dr. Ralph DeFronzo (University of Texas Health Science Center) diatribe.org/the-diatribe-foundation-and-tcoyd-11th-annual-forum |
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Post by sayhey24 on Jun 3, 2022 5:50:06 GMT -5
I don't care one bit for these shots once a week or the side effects.... My dad can't even go anyplace because he has to be near a bathroom at all times... It's been so bad that they had to cut the dose in half... I am awaiting his A1C... How much you wanna make a bet it is going to be horrible... Ozempic is bad stuff... Anything that causes chronic diarrhea can't be good!!!! Not ALL kids think pumps are the way to go... Just ask Afrezza Jake!!!! The kids don’t prescribe their treatment. And I agree with Aged that being successful with kids and T1 kids especially would be huge. I’ve begun to say, “Afrezza is the SAFE choice”. I’m hoping it catches on. Early on in my career I remember hearing the phrase, “Nobody ever got fired for buying Big Blue”. It was a truism that IBM computers, typewriters, and other business equipment were the safe choice. SAFETY matters. Afrezza is the SAFE choice. I would second that "Not ALL kids think pumps are the way to go". Do you guys have any idea what its like for a kid playing soccer running around with a pump? How about going to the beach? Its summer on the east coast. How many kids want to wear a pump to the Wildwoods, or Jones Beach or the OBX? How many moms are going to let there kids wear a pump to the Hamptons if they don't have to? Al and Medtronic got the doctors to prescribe pumps to kids as the safer way to go. It seems like an easy fix if afrezza can show to be just as safe. But lets be clear the kids are the target for the T1 market not the T2s. Mike needs to address both markets at the same time. |
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Post by peppy on Jun 3, 2022 6:27:35 GMT -5
Since 2016 the scene is the same. The board talks about Afrezza. agedhippie comes on and says NOPE. We all word process........ Rinse and repeat. Kids get put on pumps so they learn to feel bad right away.  |
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Post by prcgorman2 on Jun 3, 2022 7:10:34 GMT -5
The kids don’t prescribe their treatment. And I agree with Aged that being successful with kids and T1 kids especially would be huge. I’ve begun to say, “Afrezza is the SAFE choice”. I’m hoping it catches on. Early on in my career I remember hearing the phrase, “Nobody ever got fired for buying Big Blue”. It was a truism that IBM computers, typewriters, and other business equipment were the safe choice. SAFETY matters. Afrezza is the SAFE choice. I would second that "Not ALL kids think pumps are the way to go". Do you guys have any idea what its like for a kid playing soccer running around with a pump? How about going to the beach? Its summer on the east coast. How many kids want to wear a pump to the Wildwoods, or Jones Beach or the OBX? How many moms are going to let there kids wear a pump to the Hamptons if they don't have to? Al and Medtronic got the doctors to prescribe pumps to kids as the safer way to go. It seems like an easy fix if afrezza can show to be just as safe. But lets be clear the kids are the target for the T1 market not the T2s. Mike needs to address both markets at the same time. When I was young I had a cousin who wore an experimental pump (which they were at that point in time) to our family reunion, so I guess I could say I have some idea, but not really, and I don’t think it matters. I haven’t seen anybody argue that the T2 market is not worth trying to market to, but I haven’t seen a lot of love for the gimmiky self-proclaimed SOC card idea either, and that’s from the investors, let alone medical professionals. You’re champing at the bit and creative and invested (obviously) and those are all good things and so I don’t want to pour cold water on your ideas. I like seeing them even if I don’t necessariliy agree whole-heartedly. Creativity is good and it should be rewarded. I think I’ve become fixated on SAFETY as the issue partly because of Bill@VDEX, stevil, aged, Matt, and others who’ve convinced me that doctors who prescribe medication for PWDs, and PWDs themselves loathe change. That resonates with me. I see it in the script counts. We talk about Fear, Uncertainty, and Doubt (FUD) [another term I’ve heard began with IBM] but we say it is the negative posting which is the FUD but there’s even more substantial FUD amongst prescribers and PWDs. And there should be if they’re conditioned to thinking FIRST about injectible insulins. Those damn things KILL PEOPLE. The doctors are taught and it’s in their credo, “Do no harm”. But, the reality is they often have to make judgement calls about what in their treatment is likely to come closest to that ideal? Oral meds and once-a-week treatments that are “well tolerated” are going to be in that mix and clearly, hordes of sales people with fat portfolios of FDA-approved product which appear on the SOC is going to convince them they’re doing the right thing. The prescribers will sleep very comfortably at night ignoring Afrezza. You were spot on with your advocacy for “Seeing is believing”. Mannkind needs to shove it in the face of the prescribers (who are the key source of sales after all) that where SAFETY matters (and it always matters), “Afrezza is the SAFE choice”. It should not be hard. It should be “the easiest job in the world” to convince Endos and PCPs that a body that is deficient a human hormone should be provided with more of the hormone instead of HARMING parts of the body in order to either decrease the need for the hormone or increase the production of the hormone, or both. The reason it isn’t the easiest job in the world (obviously) is because of the concerns about SAFETY. Injectible insulin KILLS. This is a key point. Who gives a shit if Afrezza is inhalable? Insulin not being able to be inhaled is not the key issue. Clearly. PWDs have been saved from death for decades with injectible insulin (and also killed by it too). In the mind of prescribers inhalable insulin is a convenience and the fact that it doesn’t dose the same scares them. And, while people will pay for convenience, do prescribing doctors give a shit if something is convenient for their patient? They do some if they care about compliance, and they do, but it’s not the uppermost consideration for treatment. “Do No Harm” is. The key points are, “Injectible insulin KILLS”, and “Afrezza (inhalable) insulin is the SAFE choice”. Afrezza is the better mousetrap. Prove that it is the SAFE choice, demonstrate it is the SAFE choice, advertise that it is the SAFE choice, and the world of prescribers will beat a path to Mannkind’s door. |
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Post by sayhey24 on Jun 3, 2022 9:32:38 GMT -5
Man2 - you make some good points but lets start with the SoC card. It is not gimmicky. It exists today. The current card is IMO is a real mess. Now while the ADA is the whale there are several other SoCs. For the past 8 years the ADA has given afrezza no respect. In the T2 world the Affinty2 trial should have gotten it some respect but it never happened. Even when Kendall pushed it we got no respect. Its time for a new trial which the ADA can not ignore. Dose afrezza correctly and monitor with CGMs and afrezza will blow away Mounjaro A1c. Mark my words the big push this weekend will be Mounjaro.
The key to doctors prescribing is they need to follow "the standard". However a good sales job can push a new standard or even a competing standard. If the ADA is not going to listen Mike needs to develop a competing standard. The T2 market is no small potatoes. Afrezza should be doing $10B a year if GLP1s are doing $11B. We can call what Purdue did gimmicky but it worked. Every doctor and hospital used the damn thing. The key was, it was simple. The new T2 SoC card needs to be simple and have afrezza as Step 2.
In med school, at least at UPenn the kids get about 3 weeks on diabetes. They are basically walked through the ADA SoC for treating T2s.
Another problem is we are not going to get past the fact that insulin is dangerous. It is dangerous. While we say afrezza is different the first thing we tell people is its insulin. That is a huge marketing mistake. For the T1s thats OK but the label dosing is wrong. For the T2s all they should know is they are taking the glucose powder. If they look on the label all they should see is the active ingredient is monomer insulin. Insulin with T2s should be the last thing they need to hear. When T2s currently hear insulin they assume they are at the end of the line. Changing that will take a long time.
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Post by sayhey24 on Jun 3, 2022 9:44:42 GMT -5
It seems Medscape agrees that Mounjaro is going to be a big deal this weekend and pushing obesity none the less "Lilly's tirzepatide for obesity will likely dominate the headlines from the American Diabetes Association (ADA) 2022 Scientific Sessions" www.medscape.com/viewarticle/974866I sure hope Mike is doing some "Seeing is Believing" demos. |
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Post by uvula on Jun 3, 2022 9:59:46 GMT -5
2 facts we should all agree on.
1. Until we do a study that shows afrezza is superior, and not merely non-inferior, it will never move up in the SOC. You can spend all day writing about how great afrezza is but it is a waste of time without the clinical study to back it up.
2. #1 takes money.
If mnkd doesn't want to spend the money, they should sell adrezza to a company that will.
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Post by sayhey24 on Jun 3, 2022 10:07:39 GMT -5
2 facts we should all agree on. 1. Until we do a study that shows afrezza is superior, and not merely non-inferior, it will never move up in the SOC. You can spend all day writing about how great afrezza is but it is a waste of time without the clinical study to back it up. 2. #1 takes money. If mnkd doesn't want to spend the money, they should sell adrezza to a company that will. Lets all first agree that Affinty2 found afrezza superior and not non-inferior. However, Mounjaro is the new big whale and a targeted trial will show afrezza superior. If Mike has money to buy V-Go then he has money to do a trial against Mounjaro. However, MNKD IMO should partner on the trial. |
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Post by peppy on Jun 3, 2022 10:08:12 GMT -5
2 facts we should all agree on. 1. Until we do a study that shows afrezza is superior, and not merely non-inferior, it will never move up in the SOC. You can spend all day writing about how great afrezza is but it is a waste of time without the clinical study to back it up. 2. #1 takes money. If mnkd doesn't want to spend the money, they should sell adrezza to a company that will. Or we could change that "the human being taking the stuff gets to choose which non-inferior insulin they want to take." Or we could change "the physician gets to make the decisions rather than the pharmacy purchasing managers?" Or we could change that, "the physician and the patient get to make the right decision for the patient." Change is hard. A bit like gun control. |
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Post by MnkdWASmyRtrmntPlan on Jun 3, 2022 11:38:01 GMT -5
2 facts we should all agree on. 1. Until we do a study that shows afrezza is superior, and not merely non-inferior, it will never move up in the SOC. You can spend all day writing about how great afrezza is but it is a waste of time without the clinical study to back it up. 2. #1 takes money. If mnkd doesn't want to spend the money, they should sell adrezza to a company that will. Lets all first agree that Affinty2 found afrezza superior and not non-inferior. However, Mounjaro is the new big whale and a targeted trial will show afrezza superior. If Mike has money to buy V-Go then he has money to do a trial against Mounjaro. However, MNKD IMO should partner on the trial. The only one I can think of that may be a partner-candidate for that is Dexcom. That would be nice, but dexcom hasn't shown any interest in partnering with MNKD yet. |
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Post by MnkdWASmyRtrmntPlan on Jun 3, 2022 11:51:00 GMT -5
It seems Medscape agrees that Mounjaro is going to be a big deal this weekend and pushing obesity none the less "Lilly's tirzepatide for obesity will likely dominate the headlines from the American Diabetes Association (ADA) 2022 Scientific Sessions" www.medscape.com/viewarticle/974866I sure hope Mike is doing some "Seeing is Believing" demos. It doesn't appear that Mike is doing any presentations this weekend. BUT, low and behold, who is the key speaker in MNKD's presentation (maybe after Kevin Kaiserman introduces him)? The one and only chief of TCOYD ... Steven Edelman. Kaiserman, Edelman and Jeremy Pettusan (also from TCOYD) are running the session on "Ultra Rapid-Acting Inhaled Insulin for Diabetes Management" for Mannkind at the 2022 ADA from 3:00 to 3:45 tomorrow (Saturday). |
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