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Post by agedhippie on Jan 10, 2024 19:20:58 GMT -5
3 complex products undergoing clinical trails, with filings targeted in FY 2024 & FY 2025 • Plan to launch 1 peptide product in FY 2024 and 3-4 peptide products in FY 2025 $ Mn North America Q2 FY24 YoY 11 P ------- I ASSUME the "1 PEPTIDE PRODUCT" is AFREZZA? ? Not unless they are selling Afrezza in North America (slide title: North America: Robust momentum in differentiated portfolio).
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Post by agedhippie on Jan 9, 2024 22:16:15 GMT -5
What is a “decent sized trial”? I would say around 300 people per arm. The truly pivotal trials like DCCT or UKPDS have thousands, but really only governments can run those. If you look at the SURPASS-2 trial Lilly ran which was comparing Mounjaro with Ozempic via a clever bit of framing to avoid the FDA getting upset (you aren't meant to compare with competitors) there were just under 450 people in each of 4 arms. Having large numbers makes the result less arguable as while you might get an outlier group of 5 people in a 100 person arm that's 5% of the arm which doctors will care about, if it's a 450 person arm it's 1% and doctors will be a lot more relaxed. This is why small trials never get traction as that group of 5 would be large percentage of the end result.
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Post by agedhippie on Jan 9, 2024 19:08:13 GMT -5
This is where changing the label, potentially the Standard Of Care, and DTC advertising and marketing may help, but the bottom-line is the bottom-line and somehow the cost of Afrezza has to be competitive to the moms. It saddens me that improved compliance and outcomes don't carry more weight with insurance providers because that's the other angle that should be persuasive. Changing the label would definitely help. Changing the SoC will take proper trial data and there are no plans for that beyond what is in flight. DTC and marketing will fail for the same reason that they did last time - negative endos, poor insurance cover, and general inertia. To change the story do a decent sized trial over six months with a six month extension and show the benefits, not the features. That will move the needle.
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Post by agedhippie on Jan 9, 2024 17:03:18 GMT -5
The nebulizer version is faster (less technology questions and more docs comfortable with the delivery) to get through trial and probably less FDA questions in the long run. ... Why would it be faster to get through trials and less FDA questions? ... Because the nebulized version already exists and has cleared Phase 1 so the FDA are familiar with it. The DPI version does not yet exist.
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Post by agedhippie on Jan 9, 2024 16:58:01 GMT -5
...Based on past experience BP will throw the kitchen sink at MNKD and getting insurance coverage is not changing... BP stopped caring the day Sanofi dumped Afrezza. Their view was that if Sanofi (ie. a BP like them) cannot make it work then it has no future. The killer was the PBMs and the lack of insurance cover, and that was to do with pricing and bundle negotiations (you can have blockbuster drug X cheap if you give me an exclusive on these other drugs.) MNKD and other small pharmas are collateral damage in the fight between the BP companies - when elephants fight, it is the grass that suffers.
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Post by agedhippie on Jan 9, 2024 16:46:43 GMT -5
Then try actually reading the label and not skimming as you read the wrong section. If you had read section 14 of the label, specifically section 14.3 the opening words are literally "SURPASS-2 (NCT03987919)" and it proceeds to describe the results which exceed the hoped for CIPLA results. SURPASS-2 is important because it mirrors the CIPLA trial. Just like previous suggestions (bundle CGMs with Afrezza, CMS will be forced to cover Afrezza because it's the only inhaled insulin for example) the go nuclear option is never going to happen because reality always intervenes. As I said I looked at the label and not the study. I could care less what Lilly called their study. Great its "SURPASS-2 (NCT03987919)". Who cares. Is Cipla adding afrezza to a basal? I thought it was just oral agents. When Mike mentioned it I was under the impression he was talking about afrezza as a mono therapy and if it hits the 2.0 it beats Mounjaro. If it comes in at 1.7 then they are the same. ... If you don't read the labels then don't be surprised when the endos do. Parts like section 14.3 of the label are the sort of thing they care about (for those who honestly don't read the label, and I can't say I blame you, that section is a summary of each of the trials with outcomes). The CIPLA trial is not a monotherapy as you would know if you had read the trial protocol. That makes SURPASS-2, which also was not a monotherapy (it only allowed metformin) the relevant comparator and that outperforms Mike's Afrezza numbers. Read the label to learn more. I don't want MNKD to go nuclear because I don't want them to go out of business. Attempting to fight both Lilly and Novo Nordisk on price will absolutely do that and very literally decimating Afrezza's net revenue.
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Post by agedhippie on Jan 9, 2024 8:36:39 GMT -5
I wasn't looking at a trial. Thats what is on the label. ... Then try actually reading the label and not skimming as you read the wrong section. If you had read section 14 of the label, specifically section 14.3 the opening words are literally "SURPASS-2 (NCT03987919)" and it proceeds to describe the results which exceed the hoped for CIPLA results. SURPASS-2 is important because it mirrors the CIPLA trial. Just like previous suggestions (bundle CGMs with Afrezza, CMS will be forced to cover Afrezza because it's the only inhaled insulin for example) the go nuclear option is never going to happen because reality always intervenes.
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Post by agedhippie on Jan 9, 2024 8:16:56 GMT -5
In consideration that the treatment period is less than 2 months total Im expecting it to stay nebulized. I agree. They already have the nebulized product so why incur a big delay while they get it onto TS. It's far better to do the trial immediately using the nebulized version and then do equivalence trial to convert to TS. In the interval you have a revenue stream from the approved nebulized version.
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Post by agedhippie on Jan 8, 2024 23:02:16 GMT -5
To get the A1c reduction Mounjaro had to add basal insulin. There was also no post prandial CGM done - AGP with Mounjaro. Afrezza will win in all cases; afrezza/basal; afrezza vs mounjaro post prandial control and replacing the basal with afrezza and adding to Mounjaro. I think it will also win afrezza alone with no basal but lets throw in icodec for the trial. ... You are looking at the wrong trial. SURPASS-2 (NCT03987919) required that the patient was on metformin alone. The HbA1c reduction was 2.37 for the 10mg dose, and 2.46 for the 15mg dose. That's why 1.5 to 2.0 reduction is hardly likely to change the SoC, it's worse than the current option and has to be taken far more often. That's not a winning proposition.
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Post by agedhippie on Jan 8, 2024 22:36:55 GMT -5
There is no way a doctor will move a patient off a satisfactory product. It's why UTHR spent all that money blocking LQDA, and why Afrezza struggles in the market today. EXACTLY why I said it. LQDA can sell Yutopia with a little hopia but, getting doctors to switch is going to be a huge hurdle, considering DPI is a superior product. It doesn't need to be superior, it just needs to be good enough. It's what happened with Afrezza and RAA - Afrezza is superior, but RAA is good enough so there is no move to change.
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Post by agedhippie on Jan 8, 2024 18:11:26 GMT -5
...At the same time poke BP in the other eye and announce Saxenda DPI. ... You realize that Novo Nordisk has Saxenda under patent? Are you suggesting MNKD should try and break the patent?
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Post by agedhippie on Jan 8, 2024 18:05:39 GMT -5
...Yutopia can be marketed by LQDA, but they're going to need to convince doctors and patients why they should take a superior product away from a patient that's happy, satisfied with the current delivery device and responding to the med... There is no way a doctor will move a patient off a satisfactory product. It's why UTHR spent all that money blocking LQDA, and why Afrezza struggles in the market today.
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Post by agedhippie on Jan 8, 2024 17:56:03 GMT -5
Did you see novo nordisk released their phase 3 results for once weekly glp1 combined with once weekly insulin. Yes and thanks for pointing that out. This goes to what I keep saying when I say we need to do the trial adding afrezza to the GLP1. I think if properly dosed afrezza will beat these results. Adding just afrezza to icodec should also be part of this study afrezza/glp1 study and it should beat these results when properly dosed. Now Mike has said Cipla is showing 1.5 - 2.0 without the GLP1. I hope that is true. ... Not going to happen. Mike has already said that. He sees GLP1 as a two year stopgap and takes the view that this makes them irrelevant for diabetes. The benefit here is going to be better compliance as people only have to take it once a week, not every time they eat. Cipla is showing 1.5-2.0 reduction allegedly which is less than GLP-1 achieves so it's hardly a gamechanger even if it is true.
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Post by agedhippie on Jan 7, 2024 15:33:14 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.
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Post by agedhippie on Jan 7, 2024 15:27:36 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. ...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. The bottom line here is that Afrezza, or indeed any other new insulin, will never be OTC. And $35 list price insulin from MNKD is a fantasy as the unit has to break even and getting into a price war with BP is not going to achieve that. Going OTC is not an option. It's nothing to do with effectiveness, or safety, or anything else (RAA has surpassed all of those for years as you would know if you had ever had to use NPH.) It is entirely to do with originally the insulin purity law (the law that no longer exists) and the subsequent FDA law regulating drugs and legends. Going OTC under the human insulin exception is a nice idea, but decades late. You could try and go OTC without the exception, that happens all the time, but Afrezza is insulin and so viewed has dangerous making it a heavy lift. Go on, give away Afrezza for $35. You can work out the cost based on the 10Q from the CoG and assigning part of the SG&A costs if you really want, I can't be bothered because I am certain it's way over $35. The BoD want the endocrine unit to break even now, not make an huge loss indefinitely. There is absolutely zero prospect of the BoD allowing Mike to start a pricing war with Lilly and Novo Nordisk, that's suicide. They could both permanently cut the price to $25 and still make money (they already sell around that price point in the rest of the world).
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