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Post by sayhey24 on Jul 5, 2022 15:24:30 GMT -5
Aged - you are 100% correct. Lilly is doing a great job positioning Mounjaro. This afrezza trial should have been announced at the ADA2022 and it needs to be a head to head against Mounjaro.
I bet once afrezza kicks butt on Mounjaro the ADA will do all it can to stonewall afrezza getting its proper place in the SoC. Mike needs to plan for this but he needs to get the trial going asap. He also better properly design it so afrezza wins big.
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Post by cretin11 on Jul 5, 2022 16:29:52 GMT -5
Thanks for the well thought out posts, sayhey. If you're basically saying layups are nice, but we'll need to extend our shooting range out a bit, then i agree.
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Post by sayhey24 on Jul 5, 2022 18:01:28 GMT -5
Thanks for the well thought out posts, sayhey. It you're basically saying layups are nice, but we'll need to extend our shooting range out a bit, then i agree. Layups are great but the goal of the game is to win. Lets not kid ourselves, MNKD was in a bad spot before Martine threw the life line. Tyvaso DPI has now provided more time to develop realistic executable plans to sell into the T1 market and the T2 market. For the T1 market the plan was already developed years ago with the pumps. No one wanted them when they first hit the market. Then they got the kids. This approach should work with afrezza. This approach is a no-brainer but Sanofi had no interest in the T1 market since their focus was Toujeo at the time. After 7 years we finally got the kids trial. Lets not forget what Sports was saying maybe 4 or 5 years ago. The kids are going to need the 2unit or what I like to call the XS cartridges. Maybe Mike has figured that out or he could just read Proboards. I don't know if they have provided the kids in the trial the XS cartridges. I sure hope they have and they have those kids dosing as needed. The goal is to win big with game changing results. The T2 market is the big win. Its $30B+. It sends MNKD pps well above $100. Al Mann believed afrezza could win a big chunk of that market. Stefan Schwartz also believed he could win a big chunk of that market. What we know is nothing is better than human insulin to control blood sugar when properly dosed. Between the pancreas and the liver they do a great job. No combination of GLP1/SGLT2s/DDP4s or the rest will do better than a healthy pancreas. When properly dosed afrezza is the next best thing to a healthy pancreas for mealtime BG control. Now, Mike needs to do the kick butt trial against the new "King of the Hill" and that's Mounjaro. The thing is even after afrezza wins in the trial Mike needs the plan to move the ADA and get afrezza's proper position in the SoC. I doubt Mike and MNKD by themselves can do this, so Mike needs a plan. There are several approaches he could take. I know what I would do. Lets see what Mike does.
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Post by agedhippie on Jul 6, 2022 13:22:13 GMT -5
... The T2 market is the big win. Its $30B+. It sends MNKD pps well above $100. Al Mann believed afrezza could win a big chunk of that market. Stefan Schwartz also believed he could win a big chunk of that market. What we know is nothing is better than human insulin to control blood sugar when properly dosed. Between the pancreas and the liver they do a great job. No combination of GLP1/SGLT2s/DDP4s or the rest will do better than a healthy pancreas. When properly dosed afrezza is the next best thing to a healthy pancreas for mealtime BG control. Now, Mike needs to do the kick butt trial against the new "King of the Hill" and that's Mounjaro. The thing is even after afrezza wins in the trial Mike needs the plan to move the ADA and get afrezza's proper position in the SoC. I doubt Mike and MNKD by themselves can do this, so Mike needs a plan. There are several approaches he could take. I know what I would do. Lets see what Mike does. Proving blood glucose superiority is just the first step. Ten years ago diabetes treatment was very glucose focused. You had insulin for glucose, ACE inhibitors for kidneys, statins for cholesterol and baby aspirin for heart. Now it turns out they can use GIP/GLP-1 and treat all of those at once. That is the narrative that Lilly are building and the numbers are impressive. Lilly are building a moat that will require a competitor to outperform them on all these axes or the response will be "yes, but that doesn't address..." This is going to require two things; a full blown trial to prove superiority for glucose control, and follow on trials covering CV and kidneys (this is what Lilly have done with Mounjaro in SURPASS-1&2) The best framing may be a trial to prove Afrezza significantly out-performs Mounjaro for glucose control, and another trial to prove that Afrezza + Mounjaro significantly outperforms Mounjaro alone. The second approach nullified the "yes but" you will get from trying to do a one for one swap to Afrezza. (I note with interest that Bloomberg already have a slot for Mounjaro in their Rx intelligence section)
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Post by sayhey24 on Jul 6, 2022 15:17:55 GMT -5
... The T2 market is the big win. Its $30B+. It sends MNKD pps well above $100. Al Mann believed afrezza could win a big chunk of that market. Stefan Schwartz also believed he could win a big chunk of that market. What we know is nothing is better than human insulin to control blood sugar when properly dosed. Between the pancreas and the liver they do a great job. No combination of GLP1/SGLT2s/DDP4s or the rest will do better than a healthy pancreas. When properly dosed afrezza is the next best thing to a healthy pancreas for mealtime BG control. Now, Mike needs to do the kick butt trial against the new "King of the Hill" and that's Mounjaro. The thing is even after afrezza wins in the trial Mike needs the plan to move the ADA and get afrezza's proper position in the SoC. I doubt Mike and MNKD by themselves can do this, so Mike needs a plan. There are several approaches he could take. I know what I would do. Lets see what Mike does. Proving blood glucose superiority is just the first step. Ten years ago diabetes treatment was very glucose focused. You had insulin for glucose, ACE inhibitors for kidneys, statins for cholesterol and baby aspirin for heart. Now it turns out they can use GIP/GLP-1 and treat all of those at once. That is the narrative that Lilly are building and the numbers are impressive. Lilly are building a moat that will require a competitor to outperform them on all these axes or the response will be "yes, but that doesn't address..." This is going to require two things; a full blown trial to prove superiority for glucose control, and follow on trials covering CV and kidneys (this is what Lilly have done with Mounjaro in SURPASS-1&2) The best framing may be a trial to prove Afrezza significantly out-performs Mounjaro for glucose control, and another trial to prove that Afrezza + Mounjaro significantly outperforms Mounjaro alone. The second approach nullified the "yes but" you will get from trying to do a one for one swap to Afrezza. (I note with interest that Bloomberg already have a slot for Mounjaro in their Rx intelligence section) Aged - 100% agree. Step 1 is kicking butt in A1C. In theory with the proper trial design and proper afrezza dosing this should be a no-brainer. Step 2 is adding Mounjaro to afrezza. I am OK splitting the $30B with Lilly. We knew going into ADA2022 Lilly was positioning Mounjaro to be the top dog in the T2 market. Once BG is under control I suspect we will see significant kidney and CV improvement without Mounjaro but we will see. Thats the hope if we believe Bernstein. I have reached out to a trial house in NJ to get an estimate to run the study. Even after showing afrezza being superior the battle with the ADA will just be starting. I have been thinking about this since Dave Kendall left. IMO doing the trial is the easy part but its been eight years. Maybe after eight years we can at least get the trial done and MNKD can get a T2 plan in place.
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Post by MnkdWASmyRtrmntPlan on Jul 8, 2022 15:32:44 GMT -5
This is great collaboration between you two. Sayhey, PLEASE set up that appointment with Mike (or, however you do it) and go over your list of advice to him. Is that possible for you to do? Also, Sayhey, you mentioned awhile ago that you can't find that Joslin article where it discussed the viruses. Is this it by chance? www.joslin.org/about/news-media/insulin-goes-viral
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Post by sayhey24 on Jul 8, 2022 17:03:51 GMT -5
This is great collaboration between you two. Sayhey, PLEASE set up that appointment with Mike (or, however you do it) and go over your list of advice to him. Is that possible for you to do? Also, Sayhey, you mentioned awhile ago that you can't find that Joslin article where it discussed the viruses. Is this it by chance? www.joslin.org/about/news-media/insulin-goes-viralLet me just say, I have hope. We will see. One thing I am doing is getting a budgetary estimate for Aged's 500 subject trial. On the Joslin info - no but this is interesting and related. It looks like some kind of press release. Joslin use to have a location on their website with various findings. This article does mention the original 4 fish viruses. What's interesting is this article talks about the viruses causing "bad insulin" which - "could indeed bind to human insulin receptors". So the theory goes the viruses kill the beta cells and also make "bad insulin" and when released block the insulin receptors. If so this might explain why insulin works better - you need less - after a meal if you stop the spike - before the "bad insulin" gets fully released and binds. This would also be the root cause of "insulin resistance" or as they called it in 1949 - receptor blocking. One thing hard to deny is more people after covid are getting diabetes and there sure looks like a connection to SARS. The good news is a lot of SARS/diabetes is getting funded now.
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Post by porkini on Jul 8, 2022 18:25:23 GMT -5
This is great collaboration between you two. Sayhey, PLEASE set up that appointment with Mike (or, however you do it) and go over your list of advice to him. Is that possible for you to do? Also, Sayhey, you mentioned awhile ago that you can't find that Joslin article where it discussed the viruses. Is this it by chance? www.joslin.org/about/news-media/insulin-goes-viralLet me just say, I have hope. We will see. One thing I am doing is getting a budgetary estimate for Aged's 500 subject trial. On the Joslin info - no but this is interesting and related. It looks like some kind of press release. Joslin use to have a location on their website with various findings. This article does mention the original 4 fish viruses. What's interesting is this article talks about the viruses causing "bad insulin" which - "could indeed bind to human insulin receptors". So the theory goes the viruses kill the beta cells and also make "bad insulin" and when released block the insulin receptors. If so this might explain why insulin works better - you need less - after a meal if you stop the spike - before the "bad insulin" gets fully released and binds. This would also be the root cause of "insulin resistance" or as they called it in 1949 - receptor blocking. One thing hard to deny is more people after covid are getting diabetes and there sure looks like a connection to SARS. The good news is a lot of SARS/diabetes is getting funded now. Just curious, if you do not know about the Wayback Machine, or if you have forgotten it exists, I think the original timeframe sayhey24 mentioned would make the site a candidate for searching here: web.archive.org/
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Post by uvula on Jul 8, 2022 20:07:16 GMT -5
Does the Wayback machine work for stock purchases?
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Post by prcgorman2 on Jul 8, 2022 20:20:57 GMT -5
Does the Wayback machine work for stock purchases? Yes, but only if you’re a talking dog that wears eyeglasses.
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