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Post by alethea on Jan 12, 2023 10:53:22 GMT -5
Blaming Mike is disingenuous. Fact is, Afrezza was rushed to get approved and we are paying the price for that today. Botched clinical trials (taking COPDers off their meds are you serious?), only non-inferior clinical trials, didn’t even have the dosing correct in any clinical trial, failure to conduct a pediatric clinical trial. I could go on. Mike is the one that got Peds going and that’s going to readout Q4 this year. Mike is the one that got Afrezza in Bazil and soon India (that’s going to readout this year as well). Mike is the one who has done multiple Phase 4 clinical trials. Mike is the one who has acknowledged that dosing was never figured out in the first place. It’s the ADA’s job to advocate for people with diabetes. We have the world’s only inhaled insulin and it mimics what’s in the body. Complete crickets from ADA. Why? Money. There’s a vested interested in the SoC by Big Pharma and they all are rewarded handsomely from it (including ADA). Let’s not kid ourselves, this has more to do with paying to play than anything else. It’s a damn shame ADA never mentions Afrezza. It’s truly unbelievable and a great case study of where medical establishment’s and gatekeeper’s intentions are at. Very, VERY well said Mango. The barriers, corruption, manipulation that has been foisted upon MNKD for all these years has vastly enriched Wall Streeters and enhanced the powerful monopoly of the drug cartel-like big insulin producers. They will not release MNKD easily. Expect wild price swings in the next few days and maybe even weeks. But with exploding growth in Tyvaso DPI, 2.5 % convertible debt, ample cash and recent record Afrezza scrips, good things are coming for MNKD and its stock price. Not to mention the continuing high level of Short Interest.
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Post by mango on Jan 12, 2023 11:12:11 GMT -5
Blaming Mike is disingenuous. Fact is, Afrezza was rushed to get approved and we are paying the price for that today. Botched clinical trials (taking COPDers off their meds are you serious?), only non-inferior clinical trials, didn’t even have the dosing correct in any clinical trial, failure to conduct a pediatric clinical trial. I could go on. Mike is the one that got Peds going and that’s going to readout Q4 this year. Mike is the one that got Afrezza in Bazil and soon India (that’s going to readout this year as well). Mike is the one who has done multiple Phase 4 clinical trials. Mike is the one who has acknowledged that dosing was never figured out in the first place. It’s the ADA’s job to advocate for people with diabetes. We have the world’s only inhaled insulin and it mimics what’s in the body. Complete crickets from ADA. Why? Money. There’s a vested interested in the SoC by Big Pharma and they all are rewarded handsomely from it (including ADA). Let’s not kid ourselves, this has more to do with paying to play than anything else. It’s a damn shame ADA never mentions Afrezza. It’s truly unbelievable and a great case study of where medical establishment’s and gatekeeper’s intentions are at. Big pharma are the sponsors of the ADA and therefore have undeniable influence. We used to see posts on PB which said how MNKD stock was manipulated in an effort to kill MNKD and Afrezza because BP was "scared". There may have been truth to those assumptions, but I doubt we'll ever know. I assume BP doesn't give a hoot about MNKD or Afrezza because they don't have to. MNKD and Afrezza are not an imminent threat to their cash cows. Prescribers and insurance providers are both reluctant and without those two things, scripts will be low and stay that way indefinitely (but perhaps not permanently). Great leaders adapt and overcome challenges and obstacles. Nobody can take away from Mike Castagna that he created a sales and marketing team out of thin air and "relaunched" Afrezza with a shoestring budget, managed carefully, and narrowly avoided bankruptcy which was the path Mannkind was on. He is owed a debt of gratitude. The question on the table is now that he's successfully managed the company to the brink of profitability (which may be very profitable) on the Tyvaso DPI accomplishment, can he take things to the next level and beyond? Time will tell of course, but sayhey's constant stream of observations and suggestions are persuasive and I am eager for Mike to take on some more risk with targeted efforts to improve the Afrezza story.
I believe the Peds outcome measures are a big risk. Have you seen them? A lot are testing for superiority. I tend to agree with most of what you said. I also believe the India clinical trial will also improve the Afrezza story. Mike's efforts while not perfect have been quite extraordinary, especially when considering what he was given to work with. While some want to state Mike is not responsible for Tyvaso, I have to disagree. Regardless if the deal was set up before Mike entered the picture the fact remains that it was Mike who oversaw the successful completion of Phase 1, manufacture of product for Phase 3, manufacture expansion, employee expansion, etc, successful FDA inspection, and now continued success of post approval manufacture. No easy task. Id personally like for Mike to go back to the drawing board and design the clinical trials necessary to change the SoC in a significant way for Afrezza. It may be too costly at this point in time or interfere with other pipeline devopments, I have no clue.
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Post by cretin11 on Jan 12, 2023 11:14:54 GMT -5
Blaming Mike is disingenuous. No, blaming Mike is not disingenuous. Perhaps you meant to use a different word or you’re just not using that word correctly. You might not agree with sayhey, but he’s definitely not being disingenuous. Sayhey backed up his point quite well (and many agree), and you stated an alternative perspective. Neither of you are being disingenuous.
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Post by prcgorman2 on Jan 12, 2023 13:02:18 GMT -5
Blaming Mike is disingenuous. No, blaming Mike is not disingenuous. Perhaps you meant to use a different word or you’re just not using that word correctly. You might not agree with sayhey, but he’s definitely not being disingenuous. Sayhey backed up his point quite well (and many agree), and you stated an alternative perspective. Neither of you are being disingenuous. I agree with mango. If you ask Google "define: disingenuous" the top result is:
not candid or sincere, typically by pretending that one knows less about something than one really does.
Another way to put this is not giving credit where credit is due. Mike gets "blame" for the continued anemic growth of Afrezza sales (which still outpaces what Sanofi did, and with far few resources to accomplish the results), but it is disingenuous to not give credit to Mike for having avoided bankruptcy and turning the company around, largely starting with the establishment of an Afrezza sales and marketing workforce and relaunching Afrezza with re-branding, etc. Finance and re-financing are also to Mike's credit. It was a tremendous accomplishment, and added to that are the Pediatric trials (which were impacted by COVID lockdowns), and the Brazil and India efforts (also impacted by COVID). And as Mango also rightly points out, regardless of how the Tyvaso DPI deal first began to be a thing, execution and results show great stewardship. So, from my perspective, the word "blame" should generally not be used in a sentence with Mike. A couple of exceptions (because nobody is perfect) were the unfortunate use of the phrase "rest and grow" and of a substantive nature, the "December surprise" raise of capital using dilutive equity which turned out to be bad timing but which was not foreseeable it would be bad timing.
Dr. David Kendall, an eminent endocrinologist, was also hired because of Mike. Kendall's results are not obvious to me. Whatever "veins of gold" he uncovered in old study results, they did not materialize as coins or ingots of gold. I think the parting was amicable and I've assumed (but do not know) that it was because Mannkind could not give Kendall the resources he needed to be able to commission a series of studies to overwhelm the ADA defenses to admitting Afrezza as a top tier treatment in the SOC. That's not a reflection on Kendall or Castagna, but on the hangover state Mannkind was left in after the failed agreement with Sanofi and the death of Dr. Al Mann.
So yes, not giving credit to Mike, and even "blaming Mike" is disingenuous if you agree with this perspective. All that said, "what have you done for me lately?" will still be asked so the requirement for superior performance doesn't end with break-even and profitability, and I'm sure Mike knows that. Investing in a penny stock with no hope of dividends is speculation dependent on anticipation of growth. Mike has to continue to produce results which feed (and reward) anticipation.
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Post by MnkdWASmyRtrmntPlan on Jan 12, 2023 15:07:27 GMT -5
...
Great leaders adapt and overcome challenges and obstacles. Nobody can take away from Mike Castagna that he created a sales and marketing team out of thin air and "relaunched" Afrezza with a shoestring budget, managed carefully, and narrowly avoided bankruptcy which was the path Mannkind was on. He is owed a debt of gratitude. The question on the table is now that he's successfully managed the company to the brink of profitability (which may be very profitable) on the Tyvaso DPI accomplishment, can he take things to the next level and beyond? Time will tell of course, but sayhey's constant stream of observations and suggestions are persuasive and I am eager for Mike to take on some more risk with targeted efforts to improve the Afrezza story.
Man PRC, you live in some alternate reality.
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Post by prcgorman2 on Jan 12, 2023 16:34:58 GMT -5
...
Great leaders adapt and overcome challenges and obstacles. Nobody can take away from Mike Castagna that he created a sales and marketing team out of thin air and "relaunched" Afrezza with a shoestring budget, managed carefully, and narrowly avoided bankruptcy which was the path Mannkind was on. He is owed a debt of gratitude. The question on the table is now that he's successfully managed the company to the brink of profitability (which may be very profitable) on the Tyvaso DPI accomplishment, can he take things to the next level and beyond? Time will tell of course, but sayhey's constant stream of observations and suggestions are persuasive and I am eager for Mike to take on some more risk with targeted efforts to improve the Afrezza story.
Man PRC, you live in some alternate reality. Ever heard of an Ad Hominem fallacy?
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Post by cretin11 on Jan 12, 2023 16:35:25 GMT -5
No, blaming Mike is not disingenuous. Perhaps you meant to use a different word or you’re just not using that word correctly. You might not agree with sayhey, but he’s definitely not being disingenuous. Sayhey backed up his point quite well (and many agree), and you stated an alternative perspective. Neither of you are being disingenuous. I agree with mango. If you ask Google "define: disingenuous" the top result is:
not candid or sincere, typically by pretending that one knows less about something than one really does.
Another way to put this is not giving credit where credit is due. Mike gets "blame" for the continued anemic growth of Afrezza sales (which still outpaces what Sanofi did, and with far few resources to accomplish the results), but it is disingenuous to not give credit to Mike for having avoided bankruptcy and turning the company around, largely starting with the establishment of an Afrezza sales and marketing workforce and relaunching Afrezza with re-branding, etc. Finance and re-financing are also to Mike's credit. It was a tremendous accomplishment, and added to that are the Pediatric trials (which were impacted by COVID lockdowns), and the Brazil and India efforts (also impacted by COVID). And as Mango also rightly points out, regardless of how the Tyvaso DPI deal first began to be a thing, execution and results show great stewardship. So, from my perspective, the word "blame" should generally not be used in a sentence with Mike. A couple of exceptions (because nobody is perfect) were the unfortunate use of the phrase "rest and grow" and of a substantive nature, the "December surprise" raise of capital using dilutive equity which turned out to be bad timing but which was not foreseeable it would be bad timing. To continue in the semantics weeds, no: "not giving credit where credit is due" is not another way to say "disingenuous." Those are two different concepts. The definition of disingenuous you cited is correct. So mango was saying sayhey is not candid or sincere and/or is pretending he knows less about the situation than he really does. That's simply false. sayhey is nothing if not candid and sincere, and he regularly shares his knowledge on these matters so he's not pretending otherwise. mango just disagrees with sayhey assigning responsibility to our longtime CEO, and mango is entitled to that perspective. Neither are being disingenuous. Also, while on one hand you say blame should not be used with Mike, you then cite a couple of examples where even you would agree he's at fault. Personally I think you exaggerate the areas where he deserves credit, but I don't believe you're being disingenuous, you really believe those things (alternate reality perhaps? LOL). Different perspectives are allowed and aren't necessarily unreasonable.
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Post by prcgorman2 on Jan 12, 2023 16:46:04 GMT -5
Fair to say an alternate view of reality. Can't actually be anything else. None of can know exactly how another person really thinks or feels. But, we can outline the arguments for what we claim we believe. I try to do that. It's more work than name calling or inferring someone is out-of-touch with reality, but also more respectable.
I'll keep it simple. I can and do defend Mike's overall performance. I also want more.
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Post by radgray68 on Jan 12, 2023 17:30:09 GMT -5
I remember that talk several months back.Somebody misheard the presentation in which Mike said “INVEST IN GROWTH” I’ve listened to every presentation at least a half dozen times and never any “rest and grow” statement. The transcription of those meetings is atrocious. I assume that’s where it came from. But I double checked it several times back then. Seeking Alpha’s transcript is always full of errors, if, indeed that’s where that statement came from.
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Post by sportsrancho on Jan 12, 2023 20:06:57 GMT -5
I remember that talk several months back.Somebody misheard the presentation in which Mike said “INVEST IN GROWTH” I’ve listened to every presentation at least a half dozen times and never any “rest and grow” statement. The transcription of those meetings is atrocious. I assume that’s where it came from. But I double checked it several times back then. Seeking Alpha’s transcript is always full of errors, if, indeed that’s where that statement came from. Oh my gosh… apologies for thinking that. He should have said something.
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Post by longliner on Jan 12, 2023 21:37:53 GMT -5
I remember that talk several months back.Somebody misheard the presentation in which Mike said “INVEST IN GROWTH” I’ve listened to every presentation at least a half dozen times and never any “rest and grow” statement. The transcription of those meetings is atrocious. I assume that’s where it came from. But I double checked it several times back then. Seeking Alpha’s transcript is always full of errors, if, indeed that’s where that statement came from. Phucking idiots.
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Post by longliner on Jan 12, 2023 23:55:16 GMT -5
I remember that talk several months back.Somebody misheard the presentation in which Mike said “INVEST IN GROWTH” I’ve listened to every presentation at least a half dozen times and never any “rest and grow” statement. The transcription of those meetings is atrocious. I assume that’s where it came from. But I double checked it several times back then. Seeking Alpha’s transcript is always full of errors, if, indeed that’s where that statement came from. Phucking idiots. Sorry, to be clear I wasn't referring to SA. I was referring to all the folks who have repeated that crap ad nauseam on all social media. As far as my investment in MNKD is concerned, they are all a bunch of cretins. In no way have they contributed to an improvement in the SOC for diabetes or Afrezza. Today, I recommended to a friend the Afrezza pediatric trials. They have a newly diagnosed type 1 child, and recently had to move due to their daycare not supporting multiple daily injections. I hope, life changing.
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Post by prcgorman2 on Jan 13, 2023 7:35:06 GMT -5
I am sorry I repeated an error (from a transcript?). I’m glad it was an error. It makes my belief in and defense of Mike Castagna’s leadership stronger.
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Post by sayhey24 on Jan 13, 2023 10:22:26 GMT -5
Fair to say an alternate view of reality. Can't actually be anything else. None of can know exactly how another person really thinks or feels. But, we can outline the arguments for what we claim we believe. I try to do that. It's more work than name calling or inferring someone is out-of-touch with reality, but also more respectable. I'll keep it simple. I can and do defend Mike's overall performance. I also want more. I can and will defend some things Mike has done but he was hired to sell afrezza. How have afrezza sales increased since Mike joined in 2016? How has he positioned it to capture both the T1 and T2s market? How long did it take to put the kids study together for the T1 market when we knew Al made the pump market by going after the kids? Mango said "Blaming Mike is disingenuous" when it comes to Mike not making more progress with the SoC. What I heard yesterday was afrezza in now for the T1 market and V-Go is for the T2 market. Not only has Mike not done the proper spade work for SoC changes but now he has thrown the towel in on the $40B T2 market for afrezza. If you can defend Mike with regard to afrezza, please do. I would love to get your perspective. At this point I would be happy with just 10% of the T2 market. BTW - Mike is getting paid a lot of money and has acquired a lot of stock. What was the pps when Mike joined in 2016 and what growth have we seen??? If we use pps to measure overall performance as our metric, please defend his performance.
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Post by peppy on Jan 13, 2023 10:30:08 GMT -5
When Mike C came on MNKD made the decision to hire a sales force..... He kept the availability in pharmacies. Blah, blah, blah.
A fine product with no sales force and no health care insurance coverage. Continuous Glucose Monitors told the story
Years later MNKD still ticking, it has a plan and profitably isn't too far away.
Good, because this insulin is fine. Blood glucose levels controlled.Easy use.
Thrilled the expansion is pulmonary, an exact fit.
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