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Post by peppy on Mar 1, 2024 12:41:57 GMT -5
Announcements, announcements. Under what is going on. It this precise moment as I type, THE NASDAQ is testing its all time highs. The $SPX and INDU, have already made new all time highs. $compq monthly chart, schrts.co/gWwizfPV |
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Post by peppy on Jan 12, 2024 16:40:15 GMT -5
At the JP Morgan Healthcare Conference yesterday, slide 6 said that Inhale-1 "interim analysis met DSMB expectations on trial size and safety." So at least there are no delays or problems related to that. I will translate that; so many people haven't dropped out that it has compromised the results, and nobody has died (literally!) The interim analysis is there to ensure that it is ethical to carry on with the trial. No one in the childhood trial has died, using a medication that adults have used for years. Also not too many people have dropped out. They are type one diabetes, drop out means back to subq. Perhaps their mothers have them in the study because their children do not like subq. ......  |
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Post by peppy on Jan 10, 2024 9:15:55 GMT -5
I take it from your words, Mannkind, Afrezza, or Diabetes are not present. ? |
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Post by peppy on Jan 8, 2024 15:32:59 GMT -5
stkt.co/2kJZLujsSlides up. Our partner United Therapeutics highlights the advantages of our delivery platform. Holy. The deal was, UTHR in charge of sales. Add to that the rebates are in place. Health insurance coverage. I'll type this here. Rare diseases. It seems to me Mike C has moved towards specialty, Rare diseases. Is this because the medication can get health insurance coverage? Also, Binder and the balance sheet. UTHR runs a clean, clean balance sheet. |
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Post by peppy on Jan 8, 2024 15:14:04 GMT -5
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Post by peppy on Jan 8, 2024 12:03:39 GMT -5
Did you see novo nordisk released their phase 3 results for once weekly glp1 combined with once weekly insulin. Basal insulin. Bagsværd, Denmark, 8 January 2024 – Novo Nordisk today announced topline results from the COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide. COMBINE 3 was a 52-week, open-label treat-to-target trial comparing the efficacy and safety of once-weekly IcoSema vs once-daily insulin glargine U100 and insulin aspart (injected 2-4 times a day during mealtimes), dosed with or without oral glucose-lowering medications, in 679 people with type 2 diabetes inadequately controlled on daily basal insulin. |
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Post by peppy on Jan 7, 2024 15:54:46 GMT -5
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Post by peppy on Jan 7, 2024 15:41:34 GMT -5
... Meat, animal products are protein and fat. Fats are high fats. cheese..... blah blah blah. The Low Carb High Fat diet diabetics, TRype 2 especially, would disagree. You can get very good results out of that diet. It was regarded as a fad initially, but there are a lot of papers in the medical journals now and it's become a recognized approach. It sort of makes sense because it was the pre-insulin treatment for diabetes. Low carb high fat type 1 diabetes? Or low carb high fat type two diabetes? If low carb high fat type two diabetes works so well.... yeah yeah. |
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Post by peppy on Jan 7, 2024 15:13:19 GMT -5
Peppy - explain to me how phthalates played a part of a ton on new diabetics after they had covid. was there a ton of new type 2 diabetes after COVID SARS2? Or Type 1, or both? Tell me more, tell me more..... I have no clue. truthfully sayhey, I am shocked by the phthalates thing. I wonder about all these apartments they are building around here. |
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Post by peppy on Jan 7, 2024 14:32:13 GMT -5
No way the FDA ever allow Afrezza to be sold OTC. The existing exceptions are the result of grandfathering under a law that no longer exists and are specific to Lilly and Novo Nordisk as the only manufacturers at that point in time. I 100% agree with you "the way things are". There is ZERO chance with the way the industry has evolved and how much money the industry is generating from diabetes that the industry would ever let afrezza be OTC without a huge disruptive force. Now, I am not sure what you mean by "under a law that no longer exists" which is not correct but doesn't really matter. The fact is afrezza is human insulin. The current argument is it has the RX on the label and there is no way the RX is getting removed until the industry is disrupted. I don't think anyone would try and argue injecting NPH is safer than inhaling afrezza. Afrezza's human insulin does have the TS component but injectable insulins also have other ingredients. Technically afrezza should be available OTC. The only way to make this happen is to first disrupt the industry. Maybe there is a better idea to disrupt the industry but my idea is to "nearly" give away afrezza. I proposed $35. Maybe thats the right price to broadly disrupt the industry maybe it needs to be lower. I don't know how much MNKD would lose if this was done for 2 years. At $35 I think afrezza is nearly break even but Mike and Steve would know. The question for them is how much of a loss would MNKD incur and how much of an impact could this have with afrezza sales being unconstrained by BP and the PBM/insurance strangle hold with Cipla results showing a significant A1c reduction? If the market can be disrupted then the conversation for OTC can start in a few years which will be about the time Apple finally introduces their Glucose watch. I also think BP will not let such a disruption occur and would rather pay a significant premium to buyout MNKD and shut afrezza down once and for all. "no way the RX is getting removed until the industry is disrupted." Stay with me, I am going to make a case that an industry disruptor is here? Phthalates? "A recent Chinese study concluded that phthalates exposure is related to the disrupted arginine and proline metabolism, resulting in the development of overweight and obesity among school-age children. "These substances have been identified as endocrine- disrupting chemicals (EDCs) which interfere with normal hormonal actions" "Some dairy products, fish, seafood, and oils are found to have a high level of phthalates." "Human epidemiological studies have shown a significant association between phthalates exposures and adverse reproductive outcomes in both women and men, for instance, type II diabetes and insulin resistance, overweight/obesity, allergy, asthma [24]." " Evidence found that DEHP was significantly related to insulin resistance and higher systolic blood pressure and the reproduction system problems, including earlier menopause, low birth weight, pregnancy loss, and preterm birth [4]" Phthalates and Their Impacts on Human Health www.ncbi.nlm.nih.gov/pmc/articles/PMC8157593/ Published online 2021 May 18. . . |
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Post by peppy on Jan 7, 2024 11:48:50 GMT -5
so far that is the case. Things change. Say aged, you are knowledge to know this..... What is the dollar cost of a submission?..... even over your objection? I mean since insulin is a $35 co charge now. ... ;By the way, I had no clue how many type two's end up in renal failure. I had to study up and look at the glomerulus. The capillaries around the glomerulus clog up with glucose or fructose and the glomerulus loses its nutrient supply and dies? It's hard to submit a request for something that no-longer exists. This is Monty Python Norwegian Blue territory  The dirty little secret of diabetic CKD is that it is driven far more by blood pressure than it is by glucose levels. This is a problem in Type 2 is that it's a metabolic disfunction and part of that is high lipids and high blood pressure - so a perfect storm. I read that or she covered that in the video. let's think this through. The capillaries encircling the glomerulus get clogged with sugar. The fluid and waste product absorption level goes down. Total blood volume goes up in a pressure system, so yes. High lipids. I still buy into the theory/reason that type two blood sugars are so high is the blood lipid levels disturbing cellar glucose absorption through some mechanism. That is the answer I came across when the medical literature saids, "we do not know what causes type two diabetes." Meat, animal products are protein and fat. Fats are high fats. cheese..... blah blah blah. . |
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Post by peppy on Jan 7, 2024 4:49:54 GMT -5
Afrezza over the counter. I think a push should be made for that. Regular inulin is over the counter. Afrezza is regular insulin. Regular insulin with a device. A syringe is a device. A pump is a device. It would solve the problems. Price could come right down as the lines ramped up. No way the FDA ever allow Afrezza to be sold OTC. The existing exceptions are the result of grandfathering under a law that no longer exists and are specific to Lilly and Novo Nordisk as the only manufacturers at that point in time. so far that is the case. Things change. Say aged, you are knowledge to know this..... What is the dollar cost of a submission?..... even over your objection? I mean since insulin is a $35 co charge now. Insurance still paying for the insured, however the uninsured can get a RAA for $35..... Things change. No black box warning on Tyvasso DPI. Things change. Pot is legal. Nancy is dead. ;By the way, I had no clue how many type two's end up in renal failure. I had to study up and look at the glomerulus. The capillaries around the glomerulus clog up with glucose or fructose and the glomerulus loses its nutrient supply and dies? |
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Post by peppy on Jan 6, 2024 19:36:37 GMT -5
I strongly advise that you go away and read the last 10Q and consider what it means to reduce the Afrezza sales revenue by an order of magnitude. The TLDR is that it absolutely would not be profitable. It’s the old gig of shoot for razor thin margin that is made up with volume. The guy that originally got me to look at MNKD and I used to joke that Afrezza ought to be a lot like crack cocaine, so just give it away for free to get users hooked, and then make money on the subscriber model. It’s still kind of tempting to think about, but I don’t have any confidence it would actually work. I’ve learned from you and too many other persons with diabetes from trolling PWD social media, several family members and close personal friends, that mealtime insulin is not a glib choice. That said, I do like the idea of Afrezza OTC, and partly because of the improved SAFETY, SAFETY, SAFETY, of Afrezza, but the price thing is still a very real question. Afrezza over the counter. I think a push should be made for that. Regular inulin is over the counter. Afrezza is regular insulin. Regular insulin with a device. A syringe is a device. A pump is a device. It would solve the problems. Price could come right down as the lines ramped up. I had no clue as to how many type two's end up with renal failure. |
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Post by peppy on Jan 6, 2024 9:12:04 GMT -5
you were talking about it. Looks like it needs to be bought.
Not like it can be made in a bio-reactor.
We have to look at the process don't we? Or do we just wish upon a star?
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Post by peppy on Jan 6, 2024 9:04:38 GMT -5
Peppy - what is the concern? We all know GLP1s are nasty - all of them. They cause issues like cancer and when compared to afrezza for T2 blood control they should not be used. However they do a hell of a job making people not want to eat. These people want to lose weight and are willing to have half their guts removed to do so. They are also willing the risk of cancer to lose a few pounds. Is Saxenda the best at reducing weight - no, but its coming off patent and it will load on TS and we can selling it for cheap. Would Pfizer's Danuglipron be a better option - probably but I don't expect Mike to pick up the phone and call Al although they are seeing a 50% drop out with people who are willing to get their gut removed. Also with Saxenda DPI Mike could totally disrupt this entire market with a $35 or $100 price tag. He could be the Jack Bogle of the pharma industry. www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-topline-phase-2b-results-oral-glp-1r. "The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C172H265N43O51 and the molecular weight is 3751.2 Daltons." Saccharomyces cerevisiae (also known as “Baker’s Yeast” or “Brewer’s Yeast”) is a unicellular fungus responsible for alcohol production and bread formation. Cultured for thousands of years, S. cerevisiae undergoes fermentation to create these products. . |
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