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Post by ktim on Apr 16, 2024 15:48:15 GMT -5
And on the point of "great product, bad company"... I kind of hate to go there, having met and in a way revering Al Mann's career as a fellow engineer and entrepreneur, but in my opinion the bad management was substantially from that time. Afrezza was the wrong product to debut technosphere, missteps were made with trial design & interactions with the FDA, and too much faith and not enough protections were put in the contract with Sanofi. I don't think there is anything within the means of MNKD that would have allowed Mike to have turned the fate of Afrezza by now.
I'm not counting on Afrezza doing much more than the modest growth presented in Mike's own projections. By the time MNKD has enough financial resources to do large new studies that might show Afrezza really gives superior long term results (health and/or financial) vs other insulins, there may be other solutions for T1 and/or T2 negating the need for exogenous insulin.
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Post by agedhippie on Apr 16, 2024 17:14:20 GMT -5
Have you considered that patients may not like needing to follow-up dose? That could be a problem that is unfixable. That would be a showstopper for me. I want to minimize my interaction with diabetes, not double it. There is a constituency who would go for the double dosing, but it's not big, and endos would hate it because of the compliance problems. Separately, the pediatrics results cannot be used to change the adult SoC. This is why there are separate adult and child trials.
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Post by caesar on Apr 16, 2024 17:15:17 GMT -5
And on the point of "great product, bad company"... I kind of hate to go there, having met and in a way revering Al Mann's career as a fellow engineer and entrepreneur, but in my opinion the bad management was substantially from that time. Afrezza was the wrong product to debut technosphere, missteps were made with trial design & interactions with the FDA, and too much faith and not enough protections were put in the contract with Sanofi. I don't think there is anything within the means of MNKD that would have allowed Mike to have turned the fate of Afrezza by now. I'm not counting on Afrezza doing much more than the modest growth presented in Mike's own projections. By the time MNKD has enough financial resources to do large new studies that might show Afrezza really gives superior long term results (health and/or financial) vs other insulins, there may be other solutions for T1 and/or T2 negating the need for exogenous insulin. Well put! Didn't know Al Mann personally, however I got to listen to him at various speaking engagements - he was special, not unlike Elon Musk and other polymaths. Elon did not invent and designing EV's (Tesla), or designing new rocket ships (SpaceX), nor did Al Mann do the heavy lifting for Afrezza. Al had the gift of being able to cobble together other people's innovations (buying their companies) and create a going concern. As a physicist and playing in the aerospace industry, he was used to bending the rules and with Mannkind he did the same with the inhaler and Martin Shkreli got wind of it, confronted Al Mann publicly and the rest is history. Al Mann was "dead man walking" after the "conspirators" were done tearing his company to shreds and even Sanofi realized that the hurdles to make Afrezza a blockbuster was not in the cards. Everybody on this board has to realize that all the studies in the world attempting to prove that Afrezza is the best mealtime insulin, will not overcome the fundamental objections: . Marketing would cost a fortune. . Endo's and clinicians would have to be trained on ever changing dosing regimentation. . To many other options, let alone the SOC protocols. . Afrezza is Expensive. . Endo's & Patients are loath to change something that seems to be working. . Ultimately simplicity and cost-effectiveness rules. On the bright side, if one uses Afrezza religiously and doses correctly over their lifetime - the LONG-TERM benefits are unbelievable. Unfortunately, most people/patients do not understand or care to worry about the long-term shortcomings of the options other than Afrezza.
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Post by agedhippie on Apr 16, 2024 17:30:28 GMT -5
Mark Cuban looked at insulin before and the killer wasn't the cost of the insulin, they had that nailed down, but rather that insulin has to be shipped refrigerated which pretty much doubled the cost. After the recent price reductions their conclusion was that consumers could get a better deal buying at list price from a pharmacy. I have posted all the numbers before along with comments from his team when asked what happened to the pilot.
Afrezza also fails one of their other metric to target established high volume drugs where generics are available.
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Post by BD on Apr 16, 2024 17:31:04 GMT -5
Um, Elon actually did and still does do a lot of design for SpaceX for sure, but even for Tesla he's the de-facto design lead of everything. He's not just an aggregator lol.
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Post by sayhey24 on Apr 16, 2024 17:36:37 GMT -5
Mark Cuban looked at insulin before and the killer wasn't the cost of the insulin, they had that nailed down, but rather that insulin has to be shipped refrigerated which pretty much doubled the cost. After the recent price reductions their conclusion was that consumers could get a better deal buying at list price from a pharmacy. I have posted all the numbers before along with comments from his team when asked what happened to the pilot. Afrezza also fails one of their other metric to target established high volume drugs where generics are available. What I can tell you is I had a front row seat. What you are saying I know first hand is not correct but I will leave it at that.
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Post by cretin11 on Apr 16, 2024 18:04:34 GMT -5
And on the point of "great product, bad company"... I kind of hate to go there, having met and in a way revering Al Mann's career as a fellow engineer and entrepreneur, but in my opinion the bad management was substantially from that time. Afrezza was the wrong product to debut technosphere, missteps were made with trial design & interactions with the FDA, and too much faith and not enough protections were put in the contract with Sanofi. I don't think there is anything within the means of MNKD that would have allowed Mike to have turned the fate of Afrezza by now. I'm not counting on Afrezza doing much more than the modest growth presented in Mike's own projections. By the time MNKD has enough financial resources to do large new studies that might show Afrezza really gives superior long term results (health and/or financial) vs other insulins, there may be other solutions for T1 and/or T2 negating the need for exogenous insulin. Everybody on this board has to realize that all the studies in the world attempting to prove that Afrezza is the best mealtime insulin, will not overcome the fundamental objections Not everyone will agree with that. We’ll never know what Al Mann could’ve done if much younger, or what would’ve happened with the right people in charge of commercialization. We can only speculate since we can’t turn back time. But if we are correct Afrezza is indeed the world’s best mealtime insulin, then it follows that proper studies could get it into the lungs of PWDs on more than a tiny niche level. Bill M and the folks at VDEX still believe it can happen. Even Mike C. said it could and would happen, when he was put in charge of commercialization. I have no reason to doubt his honesty in saying that. If it’s truly the best then those objections can be overcome.
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Post by sayhey24 on Apr 16, 2024 18:15:03 GMT -5
And on the point of "great product, bad company"... I kind of hate to go there, having met and in a way revering Al Mann's career as a fellow engineer and entrepreneur, but in my opinion the bad management was substantially from that time. Afrezza was the wrong product to debut technosphere, missteps were made with trial design & interactions with the FDA, and too much faith and not enough protections were put in the contract with Sanofi. I don't think there is anything within the means of MNKD that would have allowed Mike to have turned the fate of Afrezza by now. I'm not counting on Afrezza doing much more than the modest growth presented in Mike's own projections. By the time MNKD has enough financial resources to do large new studies that might show Afrezza really gives superior long term results (health and/or financial) vs other insulins, there may be other solutions for T1 and/or T2 negating the need for exogenous insulin. Well put! Didn't know Al Mann personally, however I got to listen to him at various speaking engagements - he was special, not unlike Elon Musk and other polymaths. Elon did not invent and designing EV's (Tesla), or designing new rocket ships (SpaceX), nor did Al Mann do the heavy lifting for Afrezza. Al had the gift of being able to cobble together other people's innovations (buying their companies) and create a going concern. As a physicist and playing in the aerospace industry, he was used to bending the rules and with Mannkind he did the same with the inhaler and Martin Shkreli got wind of it, confronted Al Mann publicly and the rest is history. Al Mann was "dead man walking" after the "conspirators" were done tearing his company to shreds and even Sanofi realized that the hurdles to make Afrezza a blockbuster was not in the cards. Everybody on this board has to realize that all the studies in the world attempting to prove that Afrezza is the best mealtime insulin, will not overcome the fundamental objections: . Marketing would cost a fortune. . Endo's and clinicians would have to be trained on ever changing dosing regimentation. . To many other options, let alone the SOC protocols. . Afrezza is Expensive. . Endo's & Patients are loath to change something that seems to be working. . Ultimately simplicity and cost-effectiveness rules. On the bright side, if one uses Afrezza religiously and doses correctly over their lifetime - the LONG-TERM benefits are unbelievable. Unfortunately, most people/patients do not understand or care to worry about the long-term shortcomings of the options other than Afrezza. I am not sure where to start. Al Mann and Elon Musk are like night and day. Elon is more of a really smart opportunist and carnival barker. Al Mann was a genius of geniuses. Back in the early days he had no one helping him. At Bell Labs there where a lot of really smart PHDs most would call them geniuses but not one could figure out how to make the solar panel work. Today we still have Spectrolab but the current CEO looks nothing like Al www.spectrolab.com/company.html#:~:text=The%20company%20was%20founded%20in,purchased%20by%20the%20Boeing%20Company. As far as afrezza - Sol Steiner had fdkp but was looking at other applications. Al was looking for a faster insulin for his pumps. He knew he personally could develop the best algorithm in the world to work with the CGM he invented and the pump would still not be good enough. I think today we call it the AID and today they are still trying to perfect the algorithm Al probably developed 30 years ago. The Sanofi failure was 100% on Ollie Brandicourt. If he did not show up Sanofi would have followed through and did the studies that they knew had to be done and the SoC today NOT be the Rube Goldberg it is. What did Ollie pay Sanofi for Exubera $1.2B? There was no way he was ever going to champion afrezza. It was dead the day he step in the door. Now let me take your list Marketing would cost a fortune. - We all know the "open secret" on pharma marketing Do't waste the money - tuckercarlson.com/the-case-against-ozempic/Endo's and clinicians would have to be trained on ever changing dosing regimentation. - thats why we have CGMs. Training is actually very easy once you know what you are doing. Training is nothing when you compare it to chasing highs and lows with RAAs. Now that is a nightmare. To many other options, let alone the SOC protocols. - NOTHING comes even close to afrezza Afrezza is Expensive. - afrezza is human insulin and fdkp - neither is expensive and the brewing process can make really big batches. What we have was a pricing decision which makes it expensive Endo's & Patients are loath to change something that seems to be working - TRUE - just start with the kids in the T1 space. The adults are mostly not going to change Ultimately simplicity and cost-effectiveness rules. - you have now defined afrezza once we get proper pricing. No more chasing highs and lows. For the T2s just take a big dose.
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Post by prcgorman2 on Apr 16, 2024 18:33:20 GMT -5
From what I can tell, Afrezza will be a welcome tool in the toolkit of persons with diabetes who want an ultra-rapid acting insulin (is anything faster than human insulin?) to cut the legs off a stubborn high. And for those willing to put in the work, it will help them achieve very good A1C/TIR results. But, unless doctors prescribe it, at scale, the result won't be a blockbuster. That idea, not a blockbuster really used to bother me no end. I thought of it as wrong. A tragedy.
Not now. I want Afrezza to continue to be available until there is something better. e.g., a new functional pancreas grown from stem cells of a person with diabetes (easy to say but not easy to do).
Now I look at MannKind like I should have looked at it from the start. A small pipeline company with a promising technology. And I should have invested accordingly. If I had, my investment would be way smaller than it is, but now I would be adding. And I plan to add more, but mostly trading around a core.
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Post by agedhippie on Apr 16, 2024 19:58:16 GMT -5
Mark Cuban looked at insulin before and the killer wasn't the cost of the insulin, they had that nailed down, but rather that insulin has to be shipped refrigerated which pretty much doubled the cost. After the recent price reductions their conclusion was that consumers could get a better deal buying at list price from a pharmacy. I have posted all the numbers before along with comments from his team when asked what happened to the pilot. Afrezza also fails one of their other metric to target established high volume drugs where generics are available. What I can tell you is I had a front row seat. What you are saying I know first hand is not correct but I will leave it at that. You are incorrect and my evidence was in my reply to you the last time you bought this up - mnkd.proboards.com/post/261201/threadThe emphasis is mine since you seem to have missed it before. Dr. Oshmyansky said the company realized it "didn't quite make sense" to sell insulin.
"We were working on bringing in an insulin product to the market for quite some time," he said at the conference. "We did actually bring one to the market, we did it as sort of a closed beta pilot to see what consumer response would be. But ultimately, direct to consumer mail-order it was $35 for a month's supply but $65 for the shipping and handling. It didn't quite make sense within our model. We almost viewed it as a solved problem from the consumer perspective at this point. You know, almost everyone has access to $35 insulin in one form or another now."
What evidence do you have? I am guenuinely curious because I haven't seen anything else on this.
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Post by caesar on Apr 16, 2024 20:43:16 GMT -5
Um, Elon actually did and still does do a lot of design for SpaceX for sure, but even for Tesla he's the de-facto design lead of everything. He's not just an aggregator lol. Nice, won't argue the point.... I would compare Elon's contribution to being similar to Steve Jobs. Both add value, but neither is a "deep thinker". Keep in mind, that was not an insult, actually it's a compliment. For what it's worth, I am as old as dirt, a refugee from the 1956 Hungarian Revolution - 5 years old when forced to flee to Austria. Had the pleasure of living "Hell" for over a decade (refugee camps, contracted viral TB, etc, etc, ...). Ultimately, for whatever reason I agreed to become the VP of Product Development & CFO for a start-up right as the DOT-COM bubble burst. In my never-ending pilgrimages to Silicon Valley and New York (Morgan Stanley, etc..), I got a healthy understanding of how Capitalism works. Met, wine and dined with the who's who of companies like Sun Microsystems, Oracle, Apple, Microsoft, Napster, 4Systems, the list goes on. Suffice it to say, people in general discount the 'id, ego, superego' of people like Al Mann - their wants & needs, their desires & obsessions and the fact that "MONEY" is their GOD, the GREASE that permits them to do whatever they please. After our gig was up (our start-up merged into a much bigger concern), a founder was offered a Chaired Professorship at Stanford, the other founder a Lead Research Position at Synopsis, most of us transitioned to 'Angel Investing', a few committed themselves to 'Anonymous', while some actually became cultural and political 'Anarchists' (think of Bitcoin & it's derivatives). I am old school, a bit more grounded, less motivated by money, and a bit more concerned about what happens to companies (i.e. Mannkind) - 'Bad Juju'. That's why I post, not because I think that anything I post will make a bit of difference to the final outcome - Mannkind one way or another will thrive (phenomenal intellectual property, patents to boot, and a couple of billion dollars' worth of tax credits). Last FYI - do not discount people like Martin Shkreli - he is dangerously focused and smart. Just like other polymaths, he is playing for the MONEY, and it's always a BAD idea to dismiss and piss a person like that off!
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Post by BD on Apr 16, 2024 22:03:14 GMT -5
You had me, caesar, until you suggested not to piss Shkreli off. Shkreli can go to friggin' hell, but at least he's not the only person in the news lately to really piss me off. Anyway, glad to have you here, I have some similar stories to tell but one generation removed, and I'm really old now, so you must be really really old. Congrats
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Post by prcgorman2 on Apr 17, 2024 6:36:29 GMT -5
Born in 51 is not old as dirt. Born in 1930? Now that’s old. Very interesting post caesar. Thank you for sharing.
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Post by sayhey24 on Apr 17, 2024 6:39:19 GMT -5
What I can tell you is I had a front row seat. What you are saying I know first hand is not correct but I will leave it at that. You are incorrect and my evidence was in my reply to you the last time you bought this up - mnkd.proboards.com/post/261201/threadThe emphasis is mine since you seem to have missed it before. Dr. Oshmyansky said the company realized it "didn't quite make sense" to sell insulin.
"We were working on bringing in an insulin product to the market for quite some time," he said at the conference. "We did actually bring one to the market, we did it as sort of a closed beta pilot to see what consumer response would be. But ultimately, direct to consumer mail-order it was $35 for a month's supply but $65 for the shipping and handling. It didn't quite make sense within our model. We almost viewed it as a solved problem from the consumer perspective at this point. You know, almost everyone has access to $35 insulin in one form or another now."
What evidence do you have? I am guenuinely curious because I haven't seen anything else on this. For what ever reason Oshmyansky was not involved in the discussions. BTW - I have never gotten a box of afrezza shipped. I doubt they refrigerate it. If they do there is no need to except for the bad label. As I said they dropped the idea for the insulin when the IRA legislation happened and probably after I pointed Mark to Walmart - "You know, almost everyone has access to $35 insulin in one form or another now." The thing we know is afrezza is not just another insulin nor it is just another diabetic treatment. What evidence do I have of what - getting Cuban interested in afrezza? Now you sound like my wife. In this case its kind of funny. It was getting late one night and he kept bugging me and she wanted to know what was wrong "at work". Of course she thought I was kidding too. You might be surprised how interested some of these people get in afrezza. Few understand how different it is from all other diabetic treatments. In the case of most they have really good gatekeepers - admins who want to "take charge" and setup formal meetings and times. I don't know if Cuban has one. You know what I get from my wife now - now who are you talking to. You just never know. We did get an invite to the west wing of the Whitehouse and got some good pictures one time. I think she liked that. What I never knew was why they call the Whitehouse reporters "pool reporters" - the press pool. The Whitehouse briefing "room" is literally over FDR's old pool which Nixon never used so they covered it and the press meet at the pool.
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Post by mayday on Apr 17, 2024 7:04:23 GMT -5
I did not know that! Thanks
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