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Post by agedhippie on Mar 10, 2023 13:14:05 GMT -5
All true. I was specifically thinking about Afrezza. The things that are needed to really help sales will all take longer than 2023. Agree, but Mike seems more confident than ever, so I don't get the feeling the Board is threatening him with termination. I think it's pretty certain they aren't threatening him with termination. I feel it's more that they will want to move resources away from Afrezza. That would be a mistake given that there are catalysts in the not to distant future.
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Post by agedhippie on Mar 10, 2023 11:51:37 GMT -5
This thread is about a theory on intestinal blockage and the question of can GLP1s be a contributing factor. I think they could be. I would say they are most likely not helping the situation. Should GLP1s be prescribed for glucose control - I would say since we have afrezza probably not. I was curious about the idea that GLP-1 and basal insulins don't handle TIR well for Type 2 diabetics so I went off and did some research. There is only one trial I can find that used CGMs and it is a sub-study of SURPASS-3 looking at treating people after oral meds no longer work (the point at which the Affinity-2 trial was set) and what their TIR looked like for 243 people over a year. What do we find? People on Mounjaro averaged 91% TIR (71-180), and 73% had a TIR of (71-140) after 52 weeks. On Tresiba people achieved 75% TIR. When the weekly basal insulins arrive you will be able to use either of these once a week for good TIR. This means we can bust two myths at once; GLP-1 obviously can control spikes, and basal insulin as a first step looks pretty good as well. Will those results persist forever? Probably not, but at this point we have no data one way or the other. So to answer your question as to whether GLP1s be prescribed for glucose control, that 91% TIR appears to validate the SoC choice. I confess, it wasn't what I had been expecting!
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Post by agedhippie on Mar 9, 2023 18:20:36 GMT -5
Feels like there is a marketing campaign coming or why bother with a new trademark given that the current one is established.
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Post by agedhippie on Mar 9, 2023 18:14:18 GMT -5
Stevil - sorry if I hurt your feelings on points 1 2 and 3. I thought you were a young guy/gal? One thing you will learn is with age comes wisdom.There is a second half to that quote. The full version is "With age comes wisdom, but sometimes age comes alone." Oscar Wilde.
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Post by agedhippie on Mar 8, 2023 20:47:10 GMT -5
Selling started about 2 weeks ago. Just curious about planned sells and continue sp dropping. Maybe shorts are using the sells to drop the UTHR sp. I wish people would read the filings. Those are all 10b5-1 trading plan sales. That will not move the share price one jot because the market does read the filings.
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Post by agedhippie on Mar 8, 2023 20:42:15 GMT -5
@sayhey It still would not surprise me regarding non diabetics getting small bowel obstructions. Again, delayed gastric emptying was a known mechanism. I’d be semi surprised if SBOs didn’t happen for some. Obese people don’t often have the healthiest of diets. If you slow the transit of low fiber/highly processed food, I’d be shocked if the mud didn’t get stuck. On that note, I’ve had a dozen or so obese patients come in with IBS just in the past couple weeks. They are already having all the symptoms listed on the side effect list of GLP-1s/GIPs. For many/most, it’s a normal day. I saw where 30k are dying in the U.S. per year. I guess just another day. What are your thoughts on the CMS decision to pay for CGMs for "insulin treated" PWDs? Assuming in 2024 afrezza is on the formularity and you have a Medicare Plan D metformin patient and the Abbott rep buys you a nice lunch and says forget the SoC we need to get your patients CGMs so they need to be "insulin treated" - 1. would you lean toward prescribing a once a day shot of basal or 2. prescribe afrezza as an after meal correction? I am curious, how many deaths are you attributing to GLP-1, and on what basis? Mayo clinic gives a laundry list of causes so I hardly think GLP-1 will change much. You probably ought to read the underlying papers, and not just the abstracts, because there are a lot of disclaimers about co-morbidities in them. Long story short - this will have zero impact on GLP-1 because the benefits are significantly greater than the risks and for doctors that's an easy choice. The CVD benefits alone more than offset it, before you even go near the diabetes benefits. The idea that a doctor is going take the risk of ignoring the SoC in exchange for a lunch is a joke I take it? Nobody risks their medical license and career for a lunch. The SoC is clear - you want to change it then do the work like the CGM makers did. I will take a chance and answer the last bit for Stevil. I suspect that he evaluates the patient and makes what he considers the best treatment is on balance.
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Post by agedhippie on Mar 8, 2023 20:30:08 GMT -5
@sayhey It still would not surprise me regarding non diabetics getting small bowel obstructions. Again, delayed gastric emptying was a known mechanism. I’d be semi surprised if SBOs didn’t happen for some. Obese people don’t often have the healthiest of diets. If you slow the transit of low fiber/highly processed food, I’d be shocked if the mud didn’t get stuck. On that note, I’ve had a dozen or so obese patients come in with IBS just in the past couple weeks. They are already having all the symptoms listed on the side effect list of GLP-1s/GIPs. For many/most, it’s a normal day. ... The most common side effects of OZEMPIC® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.Yet there is a queue around the block for this drug and people are refilling their prescriptions. If you read that article I linked in my last post for Ginger you will see that in most cases it's bad for a month or so and then settles (this is true of metformin as well btw.) If it doesn't settle you are going to drop it, if it does settle then you are staying with it (like Ginger). Does it have side effects? Sure, but so do all drugs. You just decide if the risk is worth the reward, and to Stevil's point if you are already obese and have IBS you are likely suffering these symptoms before you ever go near GLP-1 so there really is little down side from their standpoint.
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Post by agedhippie on Mar 8, 2023 20:06:20 GMT -5
And yet Ozempic is the 6th largest seller by revenue in the US. You could ask Ginger Vieira who uses it if it's worthwhile. aged, why would Ginger Vieira be using Ozempic? Ginger is a type one diabetic beyondtype1.org/getting-inhaled-insulin/Is Ginger doing the Sayhey study? I went to a website, Ginger uses metformin? Aged, do you think Ginger is on to something? Are you going to jump on the band wagon? Load em? My endo has already tried to get me to jump on that particular bandwagon and I politely declined. There is a case to be made for Type 1 diabetics taking GLP-1, and Ginger talks about why she uses it here - t1dexchange.org/semaglutide-type-1-diabetes/A lot of Type 1 use metformin although that didn't used to be the case because of the risk of lactic acidosis. Once they understood that it wasn't a viable risk (you need a lot of stars to align before you could get it) it got prescribed quite widely. It's good for insulin sensitivity, lipids, and is even protective against some cancers. My endo has various of us using it off-label before it became mainstream.
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Post by agedhippie on Mar 7, 2023 19:19:08 GMT -5
Aged - the other arm is just like Affinty 2 - placebo. GLP1s did not make the Affinity 2 trial where afrezza showed superiority. It will again on the GLP1/afrezza arm show superiority but more important it will show CGM recorded post prandial numbers. Some things take on faith and I am not going to give you evidence. What I can say is the CGM vendors were trying to get once daily basal approved but then something happened and CMS approved "insulin treated". I am pretty sure that was not a coincidence but you will need to take that on faith. You are correct the current SoC has basal before mealtime but again - don't thing of afrezza as another insulin. Think of it as an easy way to get Medicare to pay for CGMs. Maybe not so much Dexcom but Abbott has a lot of money and Robert Ford said he wants $10B in Libre sales by 2025 and he said this Medicare approval is key to opening up the T2s. Remember the CGM with a basal he said is like having a "rearview mirror" and we know a CGM with afrezza is like "Forward Looking Radar". MNKD on its own as we have learned has little chance of changing the SoC. If afrezza is an easier sell as an add-on to sell CGMs than subq insulin then all of a sudden there is big money wanting to see changes to the SoC. What we do know is subq insulin is a pain for GPs and they don't want hypos. A 4u of afrezza on top of metofrmin, etc. is not causing hypos and already has the Affinity 2 results showing superiority. Add the 8u or a couple of 12us and all of a sudden we have "Forward Looking Radar". How much of a splash did Affinity-2 make in the market? It's obvious that if you add insulin, any insulin, vs. a placebo the insulin will win. That's not going to persuade anyone medical. What happened with the CGM for insulin use approval is that the manufactures did the work and produced the evidence. CMS has a track record of doing the right thing if you can present them with evidence which means multiple large trials - they were the first to approve pumps for Type 1 diabetics which forced the commercial insurers to keep up. The CGM decision will do the same for Type 2 CGM approvals commercially. I don't think faith had any place in this. Afrezza is insulin, as inconvenient as that may be for your desires. That means that you have to get a doctor to prescribed it contrary to the SoC to get it ahead of basal insulin. That doesn't happen unless there is evidence (large scale trial data) to support the change and I have yet to see any CGM maker even starting down that track. Starting down the track to the use of CGMs by non-insulin users? Definitely. Ultimately; as you say, there is no evidence to support the idea, just that it would be nice if it was true.
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Post by agedhippie on Mar 7, 2023 18:32:36 GMT -5
I am unable to watch TV adverts for drugs in general because it's all going swimmingly until they reach the side effects section and then I am just sitting there in a state of shock. Anyway if you want to see the advert - www.ispot.tv/ad/1VpJ/mounjaro-what-if
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Post by agedhippie on Mar 7, 2023 18:26:04 GMT -5
Why do you think they are seeing this at 20 weeks and not 16 weeks in the mice? I don't think the mice were diabetic. There are a few strains the breed for diabetic research that have mutations that make them diabetic. I never liked the rodent model because it's at best a very rough approximation. They have cured Type 1 in mice, I think twice now, but the treatments have never worked in humans.
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Post by agedhippie on Mar 7, 2023 18:18:22 GMT -5
I wonder how many PWDs are dying from intestinal blockage caused by GLP1s and there has not been a direct linkage between the cause of death and GLP1s? Of those 30k how many are GLP1 users? hmmmmm 30k is a really big number, if its 10k thats a huge number. Seriously, this is garbage; if it's 10k it's a big number? If it's 1 it's a tiny number. What does that even mean? There are no grounds for either of those numbers, they are just made up from thin air.
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Post by agedhippie on Mar 7, 2023 10:32:17 GMT -5
What you are saying is not wrong but it is where the term "selected insulin products" are defined as any dosage form such as vial, pump or inhaler and any different type such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed of insulin. If you noticed it is also the only place where dosage form "vial" is mentioned. You should see "Dosage Form" is sprinkled through out the legislation and from the above we know "inhaler" is its own dosage form. I think you are trying to say the formulary includes at least 2 drugs in the most commonly prescribed categories and classes and you are trying to argue a fiasp is the same as afrezza. Since they are different categories (dosage forms) I don't think that is correct. It really goes back to the bid requirement as the section you provided is a description not a contractual requirement - we will have to see in June. What we do know is it is currently on the formularity spreadsheet and is required to be costed. I get the feeling you are really hoping it does not get included. I also have the feeling Robert Ford and Kevin Sayer really want it included. Lets see who wins. If it does its pretty clear MNKD has a brand new sales force who also happens to sell Libres and G7s. They also have a brand new game plan for going after the T2 market. All I know is Mike needs to keep a close eye on this and he needs to get the GLP1/afrezza study kicked off ASAP. Did you read the article I posted in the news thread? Not good for the GLP1s. Contrary to your feelings I really do hope Afrezza is mandated because I want diabetics to have as many options as possible. My other hope is world peace, but I don't think that's likely either. Don't confuse desire and reality (although I think the Afrezza mandate is far more likely to become reality) Inhaler is definitely it's own dosage form. However, there is no requirement to offer every dosage form possible. The references to dosage form scattered throughout the Act are around data aggregation and not formularies. Afrezza is a good example of dosage forms. Afrezza's class is human insulin (with Humulin R and Novolin R) and the dosage form is inhaled (Fiasp's class is RAA and dosage form is subq and vial.) I see no evidence that Robert Ford and Kevin Sayer care one way or the other. In the SoC basal insulin comes ahead of mealtime insulin. Their focus now is on getting CGMs extended to non-insulin users because that's the growth area. I agree that a GLP-1 + Afrezza trial would be good, but I am not sure what the other arm should be, GLP-1 + RAA or basal? That news isn't going to have any impact on GLP-1. It's the old problem of 4x increase is a great headline, but 4x a tiny number remains a tiny number. Look at the actual numbers vs. the risk of not taking the drug.
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Post by agedhippie on Mar 7, 2023 10:23:39 GMT -5
The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase. You say tomato I say tomato. Nausea Vomiting Diarrhea Abdominal pain Constipation www.novo-pi.com/ozempic.pdfAnd yet Ozempic is the 6th largest seller by revenue in the US. You could ask Ginger Vieira who uses it if it's worthwhile.
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Post by agedhippie on Mar 6, 2023 21:19:56 GMT -5
I guess it also bears repeating; inhaled insulin is not mentioned in the Inflation Reduction Act of 2022 except in the context of the modification to the Safe Harbor provision of the Internal Revenue Code (taxes) in order to protect high deductible health plans. In other words the Act does no impose a requirement to supply all forms. This means the requirement to offer inhaled insulin is dependent on the CMS modifying their policy to require it. So far I have found nothing to suggest that they have moved off the two drug per drug category rule to requiring (as opposed to allowing) different formats. The two drug rule from the medicare.gov site: What Medicare Part D drug plans coverAn in-depth review of Part D with links to the underlying legislation: medicareadvocacy.org/medicare-info/medicare-part-d/
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