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Post by sayhey24 on Aug 10, 2023 9:04:22 GMT -5
... For Medicare both Abbott and Dexcom want to sell CGMs but the PWD needs to take insulin. This flips the GLP1 usage a little. The real power of the CGM is with prandial insulin but what T2 wants to take injections when they can inhale and have better control? The CGM vendors don't care if the PWD takes a basal or prandial. All they care about is the PWD is using insulin. Icodec will fit the bill but whats the CGM going to tell them - most likely, they have no meal time control and need afrezza. Prandial insulin is a long way down the treatment steps so CGM makers are not going to help because by the time the patient is on a prandial insulin they are already on a basal and so eligible for a CGM. Their focus is on getting CGMs for GLP-1 users and that's where they are spending their energy. If they were going to promote an insulin it would be Icodec or similar alongside a GLP-1 because that fits the SoC. Short of a change in the SoC the idea of getting CGM makers to push Afrezza is going nowhere. Says you. We will see. We now have time to play the long game thanks to Martine and Tyvaso DPI. Will it take time to change the SoC, absolutely. Will it take some trials Mike has not done yet, absolutely. The great news is we know the power of the CGM and we know the power of afrezza. We also know no one has anything in development which is better. The first step is getting the pre auth removed from Medicare . That was Mikes #1 job this year. I told him Medicare would open up afrezza sales and guess what, he is now starting to see it. You know what they say, seeing is believing. He hedged on Monday with maybe 2024 or maybe 2025. I want 2024 but I am not sure he did all the lobbying he needed to do. It all becomes public in October. Robert Ford can sell his CGM with icodec but what is the CGM going to tell the doctor? As Robert said, his CGM with a basal is like looking in the rear view mirror. It has little power. What it is going to tell the PWD and the doctor is they have lost meal time control. Now you add the afrezza to the CGM and you are now demonstrating the power of the CGM and selling more CGMs as you show their power. The reality is over time with the CGM, afrezza will be the go to for the T2 not the icodec. Once taking afrezza they will never need the icodec. Is all this happening over night - NO but it will. The CGM is now staged to "save" afrezza and with Medicare its pretty much paid for. I knew the CGM was but I never thought Medicare was going to be that important for saving afrezza 5 years ago. I loved Mike's comment about with afrezza not needing the pumps and pump supplies and how thats a big selling point. I was wondering if he realized he too is selling a psuedo pump and no one will need that either. |
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Post by prcgorman2 on Aug 10, 2023 9:08:02 GMT -5
... For Medicare both Abbott and Dexcom want to sell CGMs but the PWD needs to take insulin. This flips the GLP1 usage a little. The real power of the CGM is with prandial insulin but what T2 wants to take injections when they can inhale and have better control? The CGM vendors don't care if the PWD takes a basal or prandial. All they care about is the PWD is using insulin. Icodec will fit the bill but whats the CGM going to tell them - most likely, they have no meal time control and need afrezza. Prandial insulin is a long way down the treatment steps so CGM makers are not going to help because by the time the patient is on a prandial insulin they are already on a basal and so eligible for a CGM. Their focus is on getting CGMs for GLP-1 users and that's where they are spending their energy. If they were going to promote an insulin it would be Icodec or similar alongside a GLP-1 because that fits the SoC. Short of a change in the SoC the idea of getting CGM makers to push Afrezza is going nowhere. I assume that's why Dr. Kendall moved on. Direct assault on SoC was not possible without significant investment in money and time in studies which proved superiority (not non-inferiority) and SAFETY. Those are goals of the Pediatric Trial and assume it will be successful, but that conclusion still remains to be proven. Until then, my assumption is wheeling-and-dealing will likely be hamstrung at least. |
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Post by sayhey24 on Aug 10, 2023 9:51:28 GMT -5
Pay close attention to what Aged said "Their focus is on getting CGMs for GLP-1 users and that's where they are spending their energy".
Robert Ford has a zillion studies. The problem with CGMs and GLP1s are GLP1S do not stop the meal time spike. The CGM provides little power for GLP1s. They actually expose the GLP1s.
For "insulin" getting Medicare to pay for the CGM was sold as a safety thing. Its hard making that argument with the GLP1. The big focus with GLP1s is getting Medicare to pay for it. Thats not happening in 2024. Its also going to be difficult showing a real benefit of the CGM and the GLP1.
I don't know why Kendall gave up. I have always had a feeling Pfizer and Mounjaro had something to do with it and they didn't want him making waves when they were just trying to make the market for Mounjaro. Of course MNKD had no money and Mike could not afford any trials but Kendall knew that when he signed on.
Also keep in mind the kids trial will only move the SoC needle for the T1s. The India trial is the jumping point for the T2s.
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Post by prcgorman2 on Aug 10, 2023 11:06:01 GMT -5
I do wonder what "CGMs for GLP-1 users" and "spending their energy" mean. It's a different solution set than insulin and would seem better fitted for managing to A1C than to Time In Range specifically because of the post-prandial BG spike, but the slower emptying of the stomach may also help reduce the post-prandial BG spike to some degree.
The good thing about inhaling a drug is it's ability to get in the bloodstream almost instantly and to bypass the digestive tract and help with bioavailability of smaller doses of the target drug. Those aspects of TechnoSphere are not necessarily of great advantage for GLP-1 (analog). Your starting point is kind of a round peg square hole problem. I'm not saying there isn't some possibility but I suspect it's not as easy as plopping an existing GLP-1 analog on TS. My guess would be you might need to increase dosing (which isn't necessarily a big problem) and perhaps adjust the analog properties to improve longer term bioavailability. I think that part of adjusting analog properties could be more problematic. Time-release is something you typically see with oral drugs, and that is an active area of research. I can't fault you for recognizing market opportunity, but I'm less confident about TS-enabled GLP-1 analog being a good fit or low-hanging fruit for a company that's only just breaking even.
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Post by sayhey24 on Aug 10, 2023 12:28:12 GMT -5
I do wonder what "CGMs for GLP-1 users" and "spending their energy" mean. It's a different solution set than insulin and would seem better fitted for managing to A1C than to Time In Range specifically because of the post-prandial BG spike, but the slower emptying of the stomach may also help reduce the post-prandial BG spike to some degree. The good thing about inhaling a drug is it's ability to get in the bloodstream almost instantly and to bypass the digestive tract and help with bioavailability of smaller doses of the target drug. Those aspects of TechnoSphere are not necessarily of great advantage for GLP-1 (analog). Your starting point is kind of a round peg square hole problem. I'm not saying there isn't some possibility but I suspect it's not as easy as plopping an existing GLP-1 analog on TS. My guess would be you might need to increase dosing (which isn't necessarily a big problem) and perhaps adjust the analog properties to improve longer term bioavailability. I think that part of adjusting analog properties could be more problematic. Time-release is something you typically see with oral drugs, and that is an active area of research. I can't fault you for recognizing market opportunity, but I'm less confident about TS-enabled GLP-1 analog being a good fit or low-hanging fruit for a company that's only just breaking even. I think he is conflating two different things. BP is really pushing hard to get Medicare to pay for GLP1s. The CGM vendors don't have data to support benefits of CGM usage with GLP1s. As I said the CGMs expose the GLP1s lack of post prandial control and hypos with GLP1 are not that big of a risk. Then again we are talking about big money and politics so who knows. It won't be happening in 2024. What Peter Richardson published was the use of TS with native GLP1. He demonstrated benefits of using TS with it. I have reason to believe more was done and Victoza DPI would provide benefits. Until the official pilot is done all we can do is speculate. Lets say its as good as injected Victoza and provides the same "diet" benefits. Now you have a non-injected diet drug. Albert Bourla says that makes the diet market a $90B market. Others are saying $100B. All I want is the pilot and Mike on Monday said pilots are things they can do while doing everything else on his slide. Maybe I am wrong but then again maybe not. Lets just build on what we have from Richardson and see what we get. Victoza is coming off patent. IMO that $15M we spent on V-Go would be better spent on a failed study showing TS GLP1 just wont work. At least we tried going after the $100B market instead of paying $15M to dumpster dive. What I can tell you is Richardson's work seemed to be long forgotten at MNKD until last year. Maybe our new guy can take a look at it. If you have been watching the news on the GLP1 diet use a few things are emerging. One thing is the "Ozempic Shamming" now happening. Why is it happening? Some is because you have the purists who believe these people need to eat less and get in the gym but I don't think this is the major group. I think a bigger part of the shamming is if you go to tictok you see a lot of people injecting. I think a lot has to do with the perception of needing to inject and injecting is seen as bad. |
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Post by ktim on Aug 10, 2023 12:45:25 GMT -5
Sayhey... if we ever have a single payer healthcare system and you're appointed to run it, I'll definitely hold onto all my shares of MNKD and hold out for $100.
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Post by mytakeonit on Aug 10, 2023 12:53:32 GMT -5
At that point ... my number would be $500/share.
But, that's mytakeonit
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Post by prcgorman2 on Aug 10, 2023 13:29:53 GMT -5
I do wonder what "CGMs for GLP-1 users" and "spending their energy" mean. It's a different solution set than insulin and would seem better fitted for managing to A1C than to Time In Range specifically because of the post-prandial BG spike, but the slower emptying of the stomach may also help reduce the post-prandial BG spike to some degree. The good thing about inhaling a drug is it's ability to get in the bloodstream almost instantly and to bypass the digestive tract and help with bioavailability of smaller doses of the target drug. Those aspects of TechnoSphere are not necessarily of great advantage for GLP-1 (analog). Your starting point is kind of a round peg square hole problem. I'm not saying there isn't some possibility but I suspect it's not as easy as plopping an existing GLP-1 analog on TS. My guess would be you might need to increase dosing (which isn't necessarily a big problem) and perhaps adjust the analog properties to improve longer term bioavailability. I think that part of adjusting analog properties could be more problematic. Time-release is something you typically see with oral drugs, and that is an active area of research. I can't fault you for recognizing market opportunity, but I'm less confident about TS-enabled GLP-1 analog being a good fit or low-hanging fruit for a company that's only just breaking even. I think he is conflating two different things. BP is really pushing hard to get Medicare to pay for GLP1s. The CGM vendors don't have data to support benefits of CGM usage with GLP1s. As I said the CGMs expose the GLP1s lack of post prandial control and hypos with GLP1 are not that big of a risk. Then again we are talking about big money and politics so who knows. It won't be happening in 2024. What Peter Richardson published was the use of TS with native GLP1. He demonstrated benefits of using TS with it. I have reason to believe more was done and Victoza DPI would provide benefits. Until the official pilot is done all we can do is speculate. Lets say its as good as injected Victoza and provides the same "diet" benefits. Now you have a non-injected diet drug. Albert Bourla says that makes the diet market a $90B market. Others are saying $100B. All I want is the pilot and Mike on Monday said pilots are things they can do while doing everything else on his slide. Maybe I am wrong but then again maybe not. Lets just build on what we have from Richardson and see what we get. Victoza is coming off patent. IMO that $15M we spent on V-Go would be better spent on a failed study showing TS GLP1 just wont work. At least we tried going after the $100B market instead of paying $15M to dumpster dive. What I can tell you is Richardson's work seemed to be long forgotten at MNKD until last year. Maybe our new guy can take a look at it. If you have been watching the news on the GLP1 diet use a few things are emerging. One thing is the "Ozempic Shamming" now happening. Why is it happening? Some is because you have the purists who believe these people need to eat less and get in the gym but I don't think this is the major group. I think a bigger part of the shamming is if you go to tictok you see a lot of people injecting. I think a lot has to do with the perception of needing to inject and injecting is seen as bad. A few things here. The "flying hamburger" marketing was ~$10M if memory serves. I liked seeing it because it was TV DTC. It didn't move the needle. Not even the lightest wiggle. That's when all of the "you need studies" comments from industry veterans finally rang true. $10M was a lot of money for MNKD to spend with nothing to show for it. The money spent on V-Go is not like that because it provably brings in revenue which has tangible value, albeit perhaps not enough to make it a good decision, yet. Regardless, hammering the decision to do the V-Go acquisition does not equate to a TS GLP-1 pilot making sense. They are orthogonal, so it would be nice if you could maybe let go of Mike's V-Go. (There's a toaster waffle joke in there.)
I didn't know about the Ozempic shaming, but that's just childish and so I will ignore the silly people who indulge in such nonsense.
If a TS GLP-1 pilot makes sense, it has to have a value to doctors and patients and not just potential revenue value to the manufacturer. Kind of the Afrezza story. But what Afrezza does is something that other approaches have not. Ultra-rapid action. That's of special value for a prandial insulin. It's apparently of no value to a GLP-1. agedhippie has argued the unfortunate nausea side-effect of using GLP-1s is because the action is to slow emptying of the stomach causing gastritis, and the compound breaks down extremely rapidly which is why it must be an analog timed-release formula. So instantaneous access to the bloodstream is not only not of value, it's actually a problem, and the action which causes the side-effect of nausea and gastritis is not likely to change because it was inhaled versus injected versus taken orally.
So what is the hook here? You have "reason to believe more was done and Victoza DPI would provide benefits"? I believe you, but I don't know if others would. You may not be able to openly explain your assertion so not trying to get you to divulge anything you shouldn't, but just going to say its fair for folks to be skeptical in that situation.
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Post by sayhey24 on Aug 10, 2023 15:12:23 GMT -5
you said "The "flying hamburger" marketing was ~$10M if memory serves. I liked seeing it because it was TV DTC. "
I thought it was terrible. I hated it. I would have preferred a doctor doing a Sunday morning infomercial showing CGM AGPs
you said - "The money spent on V-Go is not like that because it provably brings in revenue which has tangible value, albeit perhaps not enough to make it a good decision, yet. Regardless, hammering the decision to do the V-Go acquisition does not equate to a TS GLP-1 pilot making sense."
IMO buying V-GO made as much sense as the flying hamburger but I liked the hamburger more. I understand why he did it and I also understand he wants to make it work. Hopefully we don't lose much more money on it. I do like the term "stabilizing" but we are still losing money on it. How much is not clear since they are not disclosing that. They mushed it in with afrezza and show a 72% margin. The reality is $35 afrezza has obsoleted V-Go. He said it himself on Monday in not so many words when he was arguing against pump costs and $35 insulin.
Aged is correct when he talks about the GLP1 action is to slow emptying of the stomach causing gastritis. The way these analogs work is not the same as a subq RAA or basal. The analogs are engineered to resistance DPP-4 degradation. Taking Victoza on TS should allow less to be needed and it should last as long as the injection. If Peter was correct we should also see some other benefits. Mike's objection was he was looking at a GLP1 on TS providing no additional A1c benefit. He was not looking at it as a diet product. Maybe things are different now with the diet market explosion.
Additionally and separately - he needs to get the afrezza/glp1 study going for the T2 market showing afrezza being added and replacing the GLP1 for A1c. This is a no-brainer and he has talked about doing the pilot on some of the calls but didn't want to spend the money. Maybe now we have enough money with Tyvaso DPI that he will start it.
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Post by sayhey24 on Aug 10, 2023 15:31:20 GMT -5
Sayhey... if we ever have a single payer healthcare system and you're appointed to run it, I'll definitely hold onto all my shares of MNKD and hold out for $100. For 50% of T2s we already do. Its called Medicare. The problem is the entire "health" industry is out of control. Its turned into one big corporate run industry. All the doctors I know are now working for a corporation or sold their practice to a corporation. Its all about the money but Medicare is really pretty good. To make afrezza real and huge for the T2s all we need to do is focus on the Medicare market and make sure we don't need pre auths going forward. I will say getting the pre auths this year was a big F'ing deal and now Mike is seeing the benefit. The India study should really help if Mike's 1.5-2.0 A1c reduction is reality. For the T1s the kids study should make afrezza a real player. |
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Post by prcgorman2 on Aug 10, 2023 16:11:37 GMT -5
you said "The "flying hamburger" marketing was ~$10M if memory serves. I liked seeing it because it was TV DTC. " I thought it was terrible. I hated it. I would have preferred a doctor doing a Sunday morning infomercial showing CGM AGPs you said - "The money spent on V-Go is not like that because it provably brings in revenue which has tangible value, albeit perhaps not enough to make it a good decision, yet. Regardless, hammering the decision to do the V-Go acquisition does not equate to a TS GLP-1 pilot making sense." IMO buying V-GO made as much sense as the flying hamburger but I liked the hamburger more. I understand why he did it and I also understand he wants to make it work. Hopefully we don't lose much more money on it. I do like the term "stabilizing" but we are still losing money on it. How much is not clear since they are not disclosing that. They mushed it in with afrezza and show a 72% margin. The reality is $35 afrezza has obsoleted V-Go. He said it himself on Monday in not so many words when he was arguing against pump costs and $35 insulin. Aged is correct when he talks about the GLP1 action is to slow emptying of the stomach causing gastritis. The way these analogs work is not the same as a subq RAA or basal. The analogs are engineered to resistance DPP-4 degradation. Taking Victoza on TS should allow less to be needed and it should last as long as the injection. If Peter was correct we should also see some other benefits. Mike's objection was he was looking at a GLP1 on TS providing no additional A1c benefit. He was not looking at it as a diet product. Maybe things are different now with the diet market explosion. Additionally and separately - he needs to get the afrezza/glp1 study going for the T2 market showing afrezza being added and replacing the GLP1 for A1c. This is a no-brainer and he has talked about doing the pilot on some of the calls but didn't want to spend the money. Maybe now we have enough money with Tyvaso DPI that he will start it. I didn't say I liked the "flying hamburger" commercial. I said I liked "seeing it because it was TV DTC". The part I liked was TV DTC, not the "flying hamburgers". I thought it was lackluster at best. A much better commercial would have been two diabetics sitting down at a pizza joint, one disappears to the bathroom, the other sits at the table. The one who went to the bathroom asks, "Why aren't you eating?" The response, "I'm eating, I'm just not injecting insulin anymore". There could be a thousand variations including time lapse on a CGM. From what I've been told, that would never fly with the FDA. Too bad, because that story is not BS and I think it would be way more interesting than flying hamburgers to very many persons with diabetes.
I would avoid using the phrase "no-brainer". Drug development and marketing takes brains, and money, and time. Your points about "Taking Victoza on TS should allow less to be needed and it should last as long as the injection" and "not looking at it as a diet product" are more persuasive, but I've no way of assessing whether the assertion regarding Victoza on TS being just as effective while using less drug is accurate or reasonable.
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Post by agedhippie on Aug 10, 2023 17:38:40 GMT -5
.. Robert Ford has a zillion studies. The problem with CGMs and GLP1s are GLP1S do not stop the meal time spike. The CGM provides little power for GLP1s. They actually expose the GLP1s. ... Lilly has trial data for people on Mounjaro with 91.2% TIR, and 72% between 80-140 from the SURPASS-3 trial. Against that getting Afrezza to preempt GLP-1 in the Type 2 SoC is a very hard sell. Add in the cardiovascular study results from Novo Nordisk and I really cannot see it happening, it simply offers much better value. |
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Post by agedhippie on Aug 10, 2023 17:50:39 GMT -5
To make afrezza real and huge for the T2s all we need to do is focus on the Medicare market and make sure we don't need pre auths going forward. I will say getting the pre auths this year was a big F'ing deal and now Mike is seeing the benefit. The India study should really help if Mike's 1.5-2.0 A1c reduction is reality. Deciding if pre-auths are necessary is up to the insurer, not Medicare. The insurer must pick one drug from the class, but can optionally offer others and may require pre-auths on those. The India study had better hit 1.5-2.0 because Mounjaro beats those numbers. |
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Post by sayhey24 on Aug 10, 2023 18:15:18 GMT -5
prcgorman2 - my point is no one knows until we at least do the pilot study. With that $15M we could have already done the pilot. Maybe it ends up being an epic fail. Aged has told us it won't work. Says who? Has he shown us a study that says it won't work? If I remember correctly he is also the one who told us afrezza was not getting $35 Medicare. I know he told us he would not use afrezza because his NYC endos said his lungs would explode. I am still waiting for one case of lungs being damaged by afrezza. I know Mike never said TS GLP1 won't work. Maybe after he does the pilot he will but then again maybe it will work. I know Mike's concern is having a diabetes product which provides no better A1c control and going up against BP and having another situation like afrezza. The thing is he did not see it as a diet product. In the diet market the first that can get rid of the injections will be the winner. Pfizer's CEO already told us that. To steal a line from James Carville "Its the injection stupid" With diabetes society accepts diabetics have to take shots to stay alive. For losing weight it is not socially accepted. From Emily Simpson - "People are harder about Ozempic than the liposuction," Simpson said. "People get really angry. I don't understand the anger. That's the part that confuses me." "What Simpson said took her by surprise was the shaming she received for using Ozempic, which she said she took by prescription for around six weeks in November, losing between five and 10 pounds." www.goodmorningamerica.com/wellness/story/ozempic-weight-loss-shame-101897139#:~:text=%22Real%20Housewives%20of%20Orange%20County,between%20five%20and%2010%20pounds. |
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Post by sayhey24 on Aug 10, 2023 18:28:58 GMT -5
.. Robert Ford has a zillion studies. The problem with CGMs and GLP1s are GLP1S do not stop the meal time spike. The CGM provides little power for GLP1s. They actually expose the GLP1s. ... Lilly has trial data for people on Mounjaro with 91.2% TIR, and 72% between 80-140 from the SURPASS-3 trial. Against that getting Afrezza to preempt GLP-1 in the Type 2 SoC is a very hard sell. Add in the cardiovascular study results from Novo Nordisk and I really cannot see it happening, it simply offers much better value. OK, so? In the Medicare market GLP1s can not compete against $35 afrezza. Do you really think these seniors are going to pay $1k+ a month when they can pay $35, get better control and not get sick in the process? Oh. and they get a CGM for a few bucks. Lets see what the India results are and if they are as Mike said they might be maybe Mike can get CMS and CGM vendors to sponsor SOC T2 changes. BTW - have one of these seniors take the "Coke Challenge" and lets see that GLP1 stop the spike. Heck. 91% it should be 100% when these people are hardly eating and what they do does not get digested. In the non-Medicare market what are these PWDs going to do in a year when they stop using it? In this market its all about backfilling the GLP1. Mike needs to do the study. Now, if I am to believe Bernstein with the BC control you can get with afrezza we will see as good, maybe better cardiovascular study results. The problem is Mike needs to do the study. |
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