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Post by sayhey24 on May 3, 2024 9:18:31 GMT -5
I can't keep up with you. For the longest time you said the 175 even though it showed superiority was not a good study because it used the placebo as the adder. Then you finally admitted it was a good study since thats the way the SoC works. Now you say we will get no movement on the SoC because we have not done enough studies. You say Inhale-1 for the kids is not enough, we need more. The Inhale-3 is not enough, I am not sure why. You said it was not for adults but it clearly is. The Inhale-2 did something and was a good size trial for the T2s and Mike said he expected a 1.5 - 2% A1C reduction. ... Read what I say, not what you think I said. Once more and slowly. The 175 trial, aka. INHALE-2, establishes is that for a broad population (good) it is better to take Afrezza than not to take anything (meh). What to you want, a slogan like "Afrezza, better than not taking anything"? This is patently trolling - The Inhale-3 is not enough, I am not sure why. You said it was not for adults but it clearly is. Look at my response to your question about how many kids there are in INHALE-3, it's easy, it's quoted in your reply (and the first quote in this reply.) No the 175 did not do that. The PWDs continue to take there current meds including DDP4 if they were taking that. They then added afrezza or a placebo powder in the inhaler. It did what the T2 SoC treat to fail standard says to do. If you are going to do a T2 trial that is the way to do it. That is what Inhale-2 did. Now the question for Inhale-2 is what the overall A1c reduction with the proper dosing was? If it was in the 1.5 - 2% thats a big deal and on par with the GLP1s without all the safety issues. In a world with an even playing field afrezza should be step 2 after metformin. Of course we don't have an even playing field so it will be up to Mike and our lobbyists (lawyers) so lets hope Mike hired some good ones. |
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Post by sayhey24 on May 3, 2024 9:42:01 GMT -5
"Inhaled insulin is now considered “standard of care” for diabetics, according to updated guidelines from the American Diabetes Association." www.youtube.com/watch?v=POiyZVwjabQIDK, I am not seeing much. What I see is Recommendation 9.2 was updated to reflect preference of insulin analogs or inhaled insulin over injectable human insulins to minimize hypoglycemia risk for most adults with type 1 diabetes. I doubt thats getting us insurance coverage. I hope I am wrong. With Inhale-3 I would like to see words that say to get TTIR afrezza is the standard of care and to get overall 24hr control use afrezza for meals and AID for non bolus periods. |
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Post by sayhey24 on May 3, 2024 9:53:26 GMT -5
Hmmm, Mike doesn’t design the trials. That’s a collaborative effort including the FDA in some cases which I assume includes INHALE 1 because there’s been open aspiration to appeal to the FDA for approval of prescription to children. The CEO doesn’t execute the trials, publish, or interpret the results. The SoC may not change. I do not assume that it will change for some of the reasons you elaborate including and especially pressure from big industry players on an industry association. I assume that is real and not a joke. I would be sad to see you give up after all this, especially in the face of success despite Afrezza. MannKind is no longer a one trick pony. I’ve not given up on Afrezza but at this point I feel like its along for the ride and if it can somehow manage to pay for its own trials and promotion, perfect. Hope springs eternal. The trials are done for Inhale-2 and Inhale-3. Thats section 9 of the SoC. Inhale-1 will be done next year. Thats section 14. Now, its the CEO's job to hire the right lawyers to get afrezza as standard of care in the ADA's Standard of Care. Inhale-3 targets TTIR and on 6/22 we should hear it beat the AID for meals. Thats a big deal. They should also say on 6/22 for overall best A1c and TIR use afrezza for meals and AID the rest of the time. Without the right lawyers the ADA will push back on SoC changes as much as possible. BP is funding them and the last thing they want to do is have afrezza Standard of Care. If they do that it opens the insurance floodgate and solves the "Cost" issue afrezza has. Did you watch the youtube Sports posted? The doctor there talks about cost being a big blocker with the pre auth process. For some reason she thinks the section 9.2 changes are enough to force insurance companies to cover but the SoC has the word "OR" in it which provides an option to afrezza. We need great lawyers representing us with the ADA. |
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Post by agedhippie on May 3, 2024 10:57:25 GMT -5
Read what I say, not what you think I said. Once more and slowly. The 175 trial, aka. INHALE-2, establishes is that for a broad population (good) it is better to take Afrezza than not to take anything (meh). What to you want, a slogan like "Afrezza, better than not taking anything"? ... No the 175 did not do that. The PWDs continue to take there current meds including DDP4 if they were taking that. They then added afrezza or a placebo powder in the inhaler. It did what the T2 SoC treat to fail standard says to do. ... One group takes oral meds and nothing, and the other group takes oral meds and insulin. It is obvious that the insulin group does better whether that's Afrezza, RAA, or even animal insulins. Hence nobody cares about 175. |
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Post by agedhippie on May 3, 2024 11:00:42 GMT -5
... Now, its the CEO's job to hire the right lawyers to get afrezza as standard of care in the ADA's Standard of Care. ... We need great lawyers representing us with the ADA Lawyers? You really don't understand how this works do you! What would be their case as a matter of curiosity? |
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Post by mango on May 3, 2024 11:12:29 GMT -5
Afrezza is the only inhaled insulin on the market! ADA barely recognizes it ever, especially in the SoC. Look who funds the ADA-BIG PHARMA. MannKind is not one of the funders. There's also a financial disclosure attached to these things. There's more to it than that too. The SoC is a bias consensus. It's a disservice to PWDs for ADA to pretend Afrezza doesn't exist. It's the safest mealtime insulin option available, and when people get it dialed in they have fantastic results. Low risk for hypos, no insulin derived amyloidosis, no lipohypertropthy, no mealtime needle sticks. Safe and effective. I've said before ADA should be sued and investigated, maybe that really needs to happen. I'm with SayHey here on this one.
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Post by prcgorman2 on May 3, 2024 12:34:25 GMT -5
Unless ADA works differently than technical industry associations with which I have some familiarity, lawyers aren't absent (if for no other reason than to avoid anti-trust violations), but the technical stuff is done by subject matter experts and there is a consensus process. I looked into the ADA process for updating the SoC and here's something I found... The American Diabetes Association (ADA) allows its professional members to vote on changes to the Standards of Medical Care in Diabetes (SoC), which are updated annually. Professional members include healthcare professionals such as physicians, nurses, dietitians, pharmacists, researchers, and other allied health professionals who are actively involved in the care and management of diabetes. The ADA typically invites its professional members to participate in the review and approval process for the SoC through a structured review and comment period. During this period, members may provide feedback on proposed changes, recommendations, and updates to the SoC. The final version of the SoC is determined based on input from various stakeholders, including healthcare professionals, researchers, patients, and advocacy groups. All makes sense, and I'm confident lawyers are involved, but they didn't even get honorable mention.  |
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Post by agedhippie on May 3, 2024 12:52:37 GMT -5
Afrezza is the only inhaled insulin on the market! ADA barely recognizes it ever, especially in the SoC. Look who funds the ADA-BIG PHARMA. MannKind is not one of the funders. There's also a financial disclosure attached to these things. There's more to it than that too. The SoC is a bias consensus. It's a disservice to PWDs for ADA to pretend Afrezza doesn't exist. It's the safest mealtime insulin option available, and when people get it dialed in they have fantastic results. Low risk for hypos, no insulin derived amyloidosis, no lipohypertropthy, no mealtime needle sticks. Safe and effective. I've said before ADA should be sued and investigated, maybe that really needs to happen. I'm with SayHey here on this one. Suing the ADA is not an option because it is a non-governmental entity providing advice that everyone is at perfect liberty to ignore it (my old endo did!) The fact that people find it persuasive and don't widely ignore it is not grounds for a lawsuit, it's grounds for education. If you tried to sue the judge would tell you that you cannot compel a private entity to accept your point of view. |
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Post by sayhey24 on May 3, 2024 13:57:08 GMT -5
Afrezza is the only inhaled insulin on the market! ADA barely recognizes it ever, especially in the SoC. Look who funds the ADA-BIG PHARMA. MannKind is not one of the funders. There's also a financial disclosure attached to these things. There's more to it than that too. The SoC is a bias consensus. It's a disservice to PWDs for ADA to pretend Afrezza doesn't exist. It's the safest mealtime insulin option available, and when people get it dialed in they have fantastic results. Low risk for hypos, no insulin derived amyloidosis, no lipohypertropthy, no mealtime needle sticks. Safe and effective. I've said before ADA should be sued and investigated, maybe that really needs to happen. I'm with SayHey here on this one. We just want to make sure the process is fair. Some of the best lobbyists I know are lawyers and as I said we just want to make this a fair process. Doing a little background investigation of these people who are voting on the SoC changes and where they get their funding would be OK too. Aged tells us that of course afrezza wins in the 175 study, they are adding insulin. Great so lets put it in the T2 SoC where it belongs. Wait he says we need to do a large study. OK we did the 175 and it was superior and the 175 was a large study. Then he says, that study was no good because the adder was afrezza. It sure sounds like a good study to me and the FDA thought so too. I think the real concern is adding afrezza is not fair because its too damn good. When they did a similar adder study for the GLP1s they made it right into the T2 SoC. What will happen this time if the Inhale-2 really shows 1.5 -2% A1c reduction with minimal chance of a severe hypo? I would think afrezza should jump in front of the GLP1s because of all their known risks. In a fair world you would think afrezza takes the GLP1 spot in the SoC and gets insurance coverage. I would like some professional lobbyists who are also lawyers advocating for afrezza and keeping an eye on the ADA so we have a fair process. Its good to have a little leverage. In most cases I trust but like to verify. With what I have seen in the past with BP, I don't have much trust that they will keep their thumb off the scale if we just trust. Ages tells us its a voluntary guide which is kind-of but not really true. More important it dictates insurance coverage. With Inhale-1,2 and 3 we can fix the label. With Inhale-1,2 and 3 I would hope we can make some progress with the SoC. To fix the cost we have to fix the insurance coverage which will only change when the SoC changes. |
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Post by agedhippie on May 3, 2024 19:07:28 GMT -5
... Ages tells us its a voluntary guide which is kind-of but not really true. More important it dictates insurance coverage. With Inhale-1,2 and 3 we can fix the label. With Inhale-1,2 and 3 I would hope we can make some progress with the SoC. To fix the cost we have to fix the insurance coverage which will only change when the SoC changes. The SoC does not dictate insurance coverage or would all have been using CGMs years ago. The insurers have their own panels who decide if an item should be covered (or more accurately justify why coverage should be restricted.) And INHALE-2 was published 10 years ago. If that was going to change the SoC it would have done so by now! |
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Post by ktim on May 3, 2024 21:29:14 GMT -5
I wish I had your talent for always knowing what others are thinking Its not talent. Its experience. When you get as old as me you will understand. Some advice I will give you - always follow the money. Tell me why these experts have been in hiding for over 10 years? Why? Did we really learn anything with Inhale-3, no. Nothing beats afrezza for TTIR after meals. There was a reason Al Mann put $1B of his own money into this. With Inhale-1 we probably learned that the kids did not need the XSM (2U) cartridge as much as some thought. Aside from that probably not much. Are we to believe these "experts" had to wait for Inhale-3 to understand how great afrezza is? I guess we're a bit different. When I was much younger than I am now (like in my early 20's) I thought I could always discern other peoples' thoughts and motivations because I highly valued my own intelligence and acumen. As I've grown older and accumulated tons of experience, wisdom and humility, I've come to realize that was the folly of youth. |
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Post by hellodolly on May 3, 2024 21:41:29 GMT -5
... Ages tells us its a voluntary guide which is kind-of but not really true. More important it dictates insurance coverage. With Inhale-1,2 and 3 we can fix the label. With Inhale-1,2 and 3 I would hope we can make some progress with the SoC. To fix the cost we have to fix the insurance coverage which will only change when the SoC changes. The SoC does not dictate insurance coverage or would all have been using CGMs years ago. The insurers have their own panels who decide if an item should be covered (or more accurately justify why coverage should be restricted.) And INHALE-2 was published 10 years ago. If that was going to change the SoC it would have done so by now! What about lawyers making a case against the insurers? Has MNKD presented enough data to bolster the argument that it deserves the same or equal to the coverage other insulins receive and Insurers are failing to make the comparison and same conclusion? What is their case to defend their decision..."Other options are available that already address that need?" Well, that is the basis for MNKDs argument...it's the same as what is already covered but an inhaled form. Seems the first step is to get the coverage..then, later, say we are better. |
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Post by ktim on May 3, 2024 21:46:30 GMT -5
The SoC does not dictate insurance coverage or would all have been using CGMs years ago. The insurers have their own panels who decide if an item should be covered (or more accurately justify why coverage should be restricted.) And INHALE-2 was published 10 years ago. If that was going to change the SoC it would have done so by now! What about lawyers making a case against the insurers? Has MNKD presented enough data to bolster the argument that it deserves the same or equal to the coverage other insulins receive and Insurers are failing to make the comparison and same conclusion? What is their case to defend their decision..."Other options are available that already address that need?" Well, that is the basis for MNKDs argument...it's the same as what is already covered but an inhaled form. Seems the first step is to get the coverage..then, later, say we are better. Generally they cover either the Lily or the Novo RAA but not both. Afrezza (being considered equivalent to RAAs in outcome) therefore isn't being treated differently. It's excluded on most formularies in the same way one of the RAAs is. |
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Post by prcgorman2 on May 3, 2024 21:50:16 GMT -5
These things can be resolved, but its going to take more DATA about the superiority and SAFETY (SAFETY, SAFETY, ...).
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Post by prcgorman2 on May 3, 2024 21:55:54 GMT -5
Going to reiterate. Cannot (easily) differentiate on superiority? Fine. Dont. Differentiate on SAFETY SAFETY SAFETY!!!! (Damn it!) For goodness sake, Afrezza is night and day superior to RAA in terms of SAFTEY. SAFETY ( SAFETY! SAFETY!) has VALUE. Nuff said.
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