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Post by agedhippie on Mar 11, 2024 16:23:14 GMT -5
Looks like a hit piece came out an hour ago citing, among other things, poor revenue growth. We’ve got slides to show different but I bet they didn’t even care to look. This may something for management to sue for liable. In my humble, former liability claims examiner’s mind. This is pretty much textbook. If any stock starts to rise rapidly the momentum traders will kick in money and ride the rise until they hit a target, probably $5, and if they don't think it can run much longer they sell. Since there are far more sellers than buyers as they exit the price drops as they attempt to avoid being left holding the baby. Basically you are seeing the hot money following the action and it doesn't see a catalyst for MNKD in the near term so they are going to the next stock that is spiking. Meanwhile the reversion to mean traders are riding this back down towards the mean value which I think is risky as that bar may well have shifted. The question is what happens tomorrow at the open. Ideally the price establishes a new floor around here up about 30% from where it was a month ago.
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Post by agedhippie on Mar 10, 2024 15:03:11 GMT -5
If it can be shown through trial that afrezza really halts the progression of diabetes, thats game changing. I know we have said it and I know Al had said it and had some pilots studies showing this but if you can show in a large scale trial halting the progression of T2 diabetes that would make afrezza the new T2 standard of care. That would be so huge, I don't think the PBMs could block it at that point. The obvious question is why has Mike not mentioned such a potential? What would such a trial cost, $50M? If you could prove that Afrezza stopped the progression of T2 it would be huge and undoubtably make Afrezza the SoC choice. However, that is at least a five year trial with a lot of people so it would cost far more than $50M. I really don't like to think how much that would cost, usually only government entities run trials that big.
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Post by agedhippie on Mar 10, 2024 9:11:36 GMT -5
You previously explained the PBM bundling concept. Lets say MNKD had more than enough data which shows human insulin works, pancreatic insulin release works and afrezza mimics pancreatic insulin release. Lets say VDex has a 3rd party trial which says afrezza is the greatest thing since sliced bread. Lets say afrezza finally demonstrates superior TITR and better A1c. The assumption is we have all the data. Would the PBMs be forced to put afrezza on the insurance formularies? Based on what you previously said, MNKD would not have the other drugs to create bundles and therefore could not compete on price and the PBMs would not include it on the formulary. Please explain how you think this would play out. Thanks. If MNKD can demonstrate a superior A1c, the TIR is optional but nice to have, then PBMs would grumble but cover it. This would mirror what happened with RAA when it was introduced when insurers were arguing that it wasn't a significant improvement over Regular and NPH, and they didn't like the cost. As to costing I suspect that PBM would split Afrezza and RAA into separate classes and argue that for bundling was still valid as Afrezza isn't RAA. What would the coverage look like? I suspect that they would require a pre-auth, but there are levels of pre-auth. For example my insurer requires a pre-auth for a CGM, but nobody is ever refused and it's a simple electronic form. Today the pre-auth for Afrezza seems to involve wrestling alligators so this would be a huge improvement and pretty much universal. Essentially MNKD would need to redo the adult phase 3, and pediatrics phase 3 for superiority this time.
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Post by agedhippie on Mar 9, 2024 16:00:43 GMT -5
It's not the first time this has happened. When RAA was released the insurers didn't want to cover it. Lilly and Novo Nordisk did the work to get the data that showed better outcomes and the endos forced the insurers hand. Right now Afrezza lacks that data showing better outcomes as the trials have not been done. To echo what Bill said you need the data to persuade the endos to fight the battle. Contrary to what is often said here it is my experience that endos really do want to do what they see as the best for their patients, but that requires proof.
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Post by agedhippie on Mar 9, 2024 8:23:25 GMT -5
5 minutes before I posted it. Him and I have talked on the phone and he’s talked to Bill so I know when he posts anything. He had just received the information. Wasn't VDex/Bill trying to do a deal with Kaiser awhile back? What ever happened with that? I thought that was Mannkind trying to do the deal. Less a deal as such though and more education for their network to increase prescribing.
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Post by agedhippie on Mar 9, 2024 3:36:21 GMT -5
Fortunately for MNKD and Afrezza, your experience is anecdotal. The studies are adding up. Millions of very lucky children are on the horizon for Afrezza. Indeed. My experience, Ginger's experience, and the experiences of the other diabetics I know are all anecdotal and why we have trials. Studies are interesting in so far as they suggest ideas for proper trials such as INHALE-1 and INHALE-3.
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Post by agedhippie on Mar 8, 2024 18:44:00 GMT -5
Lets just use the afrezza and stop trying to use the RAA for what it is not good for. They are too damn slow. Do you see Ginger V. double dosing her RAA? She will use it when she wants the tail. Didn't we learn anything from Irl's presentation today? ... TBH I don't really pay attention to what other diabetics do, and that is true for a lot of the diabetics I know. You rapidly learn that there is an army of people out there that thinks their way is the one true light, and while that may be true for them it really isn't for you. Ginger is a good example. Afrezza works for her, but she had a sub-6.0 hBA1c with RAA even before Afrezza - that is way more work than I am prepared to even think about! My life is nothing like hers so I wish her luck and carry on my own path.
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Post by agedhippie on Mar 8, 2024 18:18:40 GMT -5
Isn't the primary takeaway from this presentation that a highly reputable industry authority (versus in-house company scientist) at a global conference, has announced there will be less hypos versus the current SOC when using Afrezza? Secondly, it's to be noted that industry influencers at all the participating test sites, including the Mayo Clinic, will now be discussing the excellent results? Just wanting to understand why some are insinuating this is not a big deal. The market has reacted nicely. Yes, that is my point. Having Irl Hirsch repeating last years numbers matters because of who he is. That is the win in this. The results in and of themselves are not going to move endos. I would love to know what else he said.
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Post by agedhippie on Mar 8, 2024 15:58:18 GMT -5
More aggressive dosing of the RAA? At the Adcom I heard the FDA say that to that doctor who got great results in the 171 when he had his patients follow-up dose. She accused him of cheating and when she asked him why he didn't do that with the RAA arm he looked at her and said "I would have killed my patients". That lady was mad. Soon after they took a break and she was in the hallway fuming. ... In the UK NHS at that time would not allow you to go onto MDI unless you used corrections. The US lagged the rest of the world on that. Of course you should use follow-up doses. Likewise it's fine to do the same with RAA provided you account for insulin onboard (pumps do that automatically for you.)
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Post by agedhippie on Mar 8, 2024 15:41:22 GMT -5
Hence why I don't find a graph only showing 2 hours very interesting... doesn't at all give the full picture of Afrezza vs RAA pk/pd difference. That data is already well known, it's essentially the same as was presented last year just with more people. ATTD 2023The first question that will be asked is what happens after the two hour mark. I suspect that was asked in the room and I would love to have heard the answer because it's the make or break question. If you have to dose twice as often with Afrezza it's going to be a problem for most people (Type 1). What mattered here was less the presentation, which was the same, but more that Irl Hirsch was putting his name behind it.
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Post by agedhippie on Mar 6, 2024 13:27:55 GMT -5
... One one hand the GPs are not going to like this when the patient comes in and starts talking AGPs and that the metformin and SGLT2 and GLP1 do crap to stop the spike. We will also start to see studies talking about how dangerous the spike is. This is going to be fun to watch. One the other hand, the horse is out of the barn to be followed by the Apple watch in a few years. The doctor will say that the spike is irrelevant and what matters is the big picture - the AGP itself. That's the current medical view and it is not about to change that I know of.
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Post by agedhippie on Mar 6, 2024 13:15:29 GMT -5
Same business model as Intel and others. Easier to build full functionality and disable parts then to produce purpose-built variations. Not trying to discourage further discussion, but we may have run the course on 4Q2023 and Full Year Results. Wait, we are discussing the 4Q2023 results?
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Post by agedhippie on Mar 6, 2024 13:11:50 GMT -5
I thought you told us that big pharma are bundling drugs and for the PBMs to get the discounts they need to buy the bundle and thats why they won't cover both Novalog and Humalog. With CGMs I am assuming this is a very different model and bundling was not involved. I would think afrezza would need to be in a whole new class of insulin to break out of your bundling theory as it was in the original Inflation Reduction Act when "form inhaled" was required. I guess this is doable but is not happening anytime soon especially for the T2s. As far as the Stelo. I like it. I think its a big step forward for wide spread glucose monitoring and people starting to ask questions on the post prandial spike. ... If the SoC requires it then bundling rules do not apply as the pharma cannot shut out the SoC pathway. The PBM can try and push you down an alternate pathway if one exists, but the cannot close it hence step therapy. This is one of the big pluses for orphan drugs - no competition. Oddly I think you are right about CGMs. I seem to be able to pick Dexcom or Libre, not sure about Senseonics as I didn't look. There is a trick where you can bypass the CGM as durable medical equipment (DME) if you get it with a pump. DME is a medical benefit, not a pharmacy benefit and so the co-pay is a lot lower. You are correct, Afrezza would need to be a new class. This has happened before; animal insulin -> human insulin -> RAA. But each of those steps had lots of data showing better outcomes for the class and Afrezza lacks that so it's grouped with RAA as it's rapid acting. I seriously doubt seeing a post prandial spike is going to move anyone. The way it will go is the person will ask the doctor about the spike and the doctor will say that the spike is far less important than the overall time in range so focus on that. For T2 this comes down to the old adage of "eat to your meter" - find what does and doesn't work for you (for some weird reason certain cupcakes don't spike me and I have no idea why.) Most people would rather avoid certain foods than take insulin, and that's not necessarily bad as a lot of those foods are highly processed.
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Post by agedhippie on Mar 6, 2024 8:00:08 GMT -5
yes, so back to my question.... Is it a G6 or G7 under a different name for over the counter sale? It is a G7 with a software mod to disable alarms and with restricted bluetooth pairing. Basically the same idea as the Dexcom One which is a G6 also with some of the functionality disabled. They are building products with standard hardware that then has different features enabled.
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Post by agedhippie on Mar 6, 2024 7:54:27 GMT -5
... According to the FDA approved afrezza label during the 175 study afrezza provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed with those that did not add afrezza to their current treatment. OK - afrezza wins. You would think if you were a T2 taking metformin and you were not controlled and your doctor prescribed to add afrezza your insurance would cover it. Nope - it will not. The PBM will deny coverage. You are not getting afrezza. ... Aged has explained the situation. BP is controlling the PBMs by "bundling" their products. If the PBM offers afrezza, the BPs will jack up their prices on other "bundled" drugs. PBMs will not cover afrezza. ... Wouldn't it make sense to run a trial with the Stelo in one group, the G7 in another and have a placebo group and afrezza as a mono therapy and see if you can get the Stelo approved for afrezza? ... Taking these in order... The 175 trial showed nothing unexpected. You took a group of people where oral meds were no-longer sufficient, split them in two and added Afrezza to one group. All that trial showed is that Afrezza is better than nothing (in fairness that was what had to be achieved for approval) and literally any insulin would have achieved that bar. However, the SoC says there are other things you should use before insulin, Afrezza or other RAA, and there was no trial against those and hence no coverage. PBMs can be forced to cover Afrezza provided you can clearly show a superior outcome. The poster child for this is the CGM. Insurers really didn't want to cover CGMs and I remember a time when you had to be hypo-unaware to get a CGM which is a very small group. But the CGM manufacturers put in the work with trials to prove that first all T1 had better outcomes if they used a CGM, and then the same for insulin using T2. It took over a decade but they got there in the end because they had indisputable data from multiple trials which changed the SoC forcing coverage. I would expect Afrezza with kids to follow the same pattern as with adults unless the trial can pull a rabbit out of the hat. AID pumps get really good results with kids, and are something the endos are familiar with. Pumps also absorb a lot of the workload from the kids and parents. All of that said, if the trial can turn iin significantly better results than the comparator arm I can see endos moving towards Afrezza. The benefit of large centers is that they have people whose sole job is handling pre-auths. You will not get Stelio approved for Afrezza because Stelio is explicitly not approved as a medical device. If you were taking Afrezza you can get a G6 or G7 today without any arguments, you don't need a Stelio.
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