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Post by sayhey24 on Jul 8, 2024 10:29:50 GMT -5
sayhey24, Not being a snot here but how does Mike go about GETTING insurance coverage? I'm asking because I am a total novice and have no understanding of how that is done. The first thing is he needs a study which beats the RAA in A1c. Inhale-3 demonstrated afrezza easily wins when properly dosed. It also demonstrated some did not dose as directed. Mike has 6 months to make sure Inhale-3 wins in the end. He needs to figure out how to juice those numbers and he needs to make sure BP does not have their finger on the scale. The second thing is Mike needs a good lawyer. IDK, maybe someone from a place like Arnold and Porter. The third thing is MNKD needs earned advertising and to make it public how afrezza should be part of the $35 Medicare. When was the last time Mike was on the morning business shows? He needs to start promoting the kids approval and how afrezza is a game changer for the kids.
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Post by prcgorman2 on Jul 8, 2024 10:33:05 GMT -5
I do not agree that Mike's #1 job is getting insurance coverage for Afrezza. His company manufactures 2 FDA-approved drugs, one of which is making MannKind profitable. And, I think MannKind is also manufacturing clofazimine, although I don't know if that is the long-term plan assuming the Fast Track approval happens. The nintedanib trial was supposed to start registering patients last month. Mike's #1 job is providing executive leadership of MannKind which is neither a single-drug company nor dependent on Afrezza for ultimate success, and I am very grateful for that. Al Mann put $1B+ of his own money into afrezza because he believed it would become the greatest selling drug of all time. Clofazmine and nitedanib were on Al's TS list but pretty far down. The potential for afrezza sales dwafts both combined. Enough of the distractions. Last year it was V-Go before that Damon Dash. Afrezza has three issues which have prevented it from selling; 1 - label; 2 - SoC; 3 - Cost. Those three issues need to be addressed. Inhale-3 has demonstrated afrezza can be as good as Al Mann believed and can help address issue's 1 and 2. Mike's #1 job is to address issue #3 and if that means getting insurance coverage then thats what he needs to do. This should be done prior to Pediatric approval. Afrezza got some good news coverage on the Inhale-3 results but once the kids are approved the news coverage will be HUGE. MNKD needs to be ready for this. Thats what I call "Executive Leadership". How many people work at MNKD - 300? In a 300 person company the executive needs to roll up their sleeves and get to work. I don't agree with your priorities. I do not believe getting Afrezza on an equal footing with RAA insulin is a simple 1, 2, 3 hit list of easily achievable goals, and after 10 years, how could it be? I won't assert "the market has spoken", but for damn sure there is a hangover still in place because of Sanofi bailing on the Afrezza worldwide marketing agreement and MannKind left without the means to pick up the pieces and act as a replacement for Sanofi. The MannKind board put leadership in place to attempt to recover but a full recovery simply wasn't possible because of the costs of marketing and trials that MannKind could not afford. I'm stunned MannKind is still here and doing well. And, I remain hopeful that Afrezza will be more successful over time, but I'm not going to obsess about it. As far as I can tell, MannKind is doing what it can with what resources it has at its disposal, and will do more as more resources come available as they appear likely to do. I think a diversified portfolio of pipeline candidates (and FDA-approved drugs) is extremely important so I'm very interested in seeing the primary candidates progressing as quickly as possible.
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Post by cretin11 on Jul 8, 2024 10:38:43 GMT -5
Thats what I call "Executive Leadership". How many people work at MNKD - 300? In a 300 person company the executive needs to roll up their sleeves and get to work. I think we're up to around 400 employees now, but your point here still holds true IMO.
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Post by prcgorman2 on Jul 8, 2024 10:47:14 GMT -5
sayhey24, Not being a snot here but how does Mike go about GETTING insurance coverage? I'm asking because I am a total novice and have no understanding of how that is done. The traditional method for some decades has been to use product discounts to incentivize Pharmacy Branch Managers (PBMs) to prioritize a drug on an insurance company's formulary list of covered drugs.
ChatGPT explains, "The formulary is designed to provide information about which drugs are covered, the tier or category each drug falls into, and any restrictions or special considerations that apply to the drug coverage."
I don't remember the byzantine set of circumstances brought about by Medicare drug coverage that led to PBMs getting bonuses based on how much money they "saved" through discounts, but the dysfunctional result was un-discounted drug prices became high so that the deep discounts looked good on paper, helped the PBMs get better paid, but screwed the under-insured.
This is my understanding, which may be flawed, so I invite better explanations from others who know better.
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Post by sayhey24 on Jul 8, 2024 12:25:00 GMT -5
Al Mann put $1B+ of his own money into afrezza because he believed it would become the greatest selling drug of all time. Clofazmine and nitedanib were on Al's TS list but pretty far down. The potential for afrezza sales dwafts both combined. Enough of the distractions. Last year it was V-Go before that Damon Dash. Afrezza has three issues which have prevented it from selling; 1 - label; 2 - SoC; 3 - Cost. Those three issues need to be addressed. Inhale-3 has demonstrated afrezza can be as good as Al Mann believed and can help address issue's 1 and 2. Mike's #1 job is to address issue #3 and if that means getting insurance coverage then thats what he needs to do. This should be done prior to Pediatric approval. Afrezza got some good news coverage on the Inhale-3 results but once the kids are approved the news coverage will be HUGE. MNKD needs to be ready for this. Thats what I call "Executive Leadership". How many people work at MNKD - 300? In a 300 person company the executive needs to roll up their sleeves and get to work. I don't agree with your priorities. I do not believe getting Afrezza on an equal footing with RAA insulin is a simple 1, 2, 3 hit list of easily achievable goals, and after 10 years, how could it be? I won't assert "the market has spoken", but for damn sure there is a hangover still in place because of Sanofi bailing on the Afrezza worldwide marketing agreement and MannKind left without the means to pick up the pieces and act as a replacement for Sanofi. The MannKind board put leadership in place to attempt to recover but a full recovery simply wasn't possible because of the costs of marketing and trials that MannKind could not afford. I'm stunned MannKind is still here and doing well. And, I remain hopeful that Afrezza will be more successful over time, but I'm not going to obsess about it. As far as I can tell, MannKind is doing what it can with what resources it has at its disposal, and will do more as more resources come available as they appear likely to do. I think a diversified portfolio of pipeline candidates (and FDA-approved drugs) is extremely important so I'm very interested in seeing the primary candidates progressing as quickly as possible. My priority for MNKD is simple - I want them to make a lot of money. They have an FDA approved drug which is the greatest advance in diabetic care since Banting and Best. They also have a revenue stream with Tyvaso DPI which is paying the bills to allow MNKD to fix the three issues afrezza has to becoming one of the greatest selling drugs of all time; label; SoC; and Cost. MNKD-101 and MNKD-201 are round-off compared to afrezza potential. The thing is afrezza's potential needs to be realized. Is the GLP1 weight loss market bigger than diabetes, maybe but afrezza should take 50% of the T1 market and at least 20% of the T2 market. Before Inhale-3 there were a lot of doubters. No more. It all comes down to dosing. Before Inhale-3 Mike never had a win in the endocrine area. Now he does and he no longer needs to be embarrassed to talk about afrezza and look down at his shoes. He no longer needs to hide afrezza from the T2 market. What he needs to do is get insurance coverage for it. BTW - Did you hear in that last interview Mike talking about his use of afrezza and his families and how his A1c is in the 5s? Mike is a case study for afrezza use in T2s. Spending the money on an afrezza/glp1 study would be money much better spent than chasing another head fake like V-Go. I am also sure MNKD-101 and 201 are not taking up that much of his day on a daily basis. If he can't oversee the MNKD-101 and 201 development while getting afrezza insurance coverage, "Houston - we have a problem".
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Post by sayhey24 on Jul 8, 2024 12:34:25 GMT -5
Thats what I call "Executive Leadership". How many people work at MNKD - 300? In a 300 person company the executive needs to roll up their sleeves and get to work. I think we're up to around 400 employees now, but your point here still holds true IMO. Do we after the RIF in sales? Then again we picked up all those R&D folks doing God only knows what. At least Pulmatrix can pay their bills while we hold off spending the money on needed afrezza studies.
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Post by agedhippie on Jul 8, 2024 16:48:45 GMT -5
... Spending the money on an afrezza/glp1 study would be money much better spent than chasing another head fake like V-Go. I am also sure MNKD-101 and 201 are not taking up that much of his day on a daily basis. If he can't oversee the MNKD-101 and 201 development while getting afrezza insurance coverage, "Houston - we have a problem". Arguing that it would be superior if only everyone dosed properly is just going to get you eyerolls because doctors know that never happens. There is nothing Mike can do to expedite insurance cover at this point so he would be wasting time trying. The insurers are just going to point to the A1c result and claim equivalence. Mike is far better off focusing on the pipeline where there are real prospects.
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Post by letitride on Jul 10, 2024 15:07:20 GMT -5
Were going up. Lets Go!
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Post by BD on Jul 10, 2024 15:14:49 GMT -5
Very encouraging action. Almost like someone is actually accumulating.
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Post by cretin11 on Jul 10, 2024 15:20:57 GMT -5
As Mr. Rogers would say, it's a beautiful day in the market (even MNKD)!
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Post by neil36 on Jul 10, 2024 16:14:13 GMT -5
Returns by calendar year on this crazy journey:
Dec 31, 2014 $28.20
Dec 31 2015 $7.25 (down 74.3%)
Dec 30 2016 $3.18 (down 56.14%)
Dec 29 2017 $2.32 (down 27%)
Dec 31 2018 $1.06 (down 54.3%)
Dec 31 2019 $1.29 (up 21.7%)
Dec 31, 2020 $3.13 (up 142%)
Dec 31, 2021 $4.37 (up 39.6%)
Dec 30, 2022 $5.27 (up 20.6%)
Dec 29, 2023 $3.64 (down 30.9%)
2024 YTD: $5.53 (up 51.9%)
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Post by neil36 on Jul 10, 2024 16:23:43 GMT -5
Getting above $6.13 would set a new eight-year high
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Post by hellodolly on Jul 10, 2024 16:31:23 GMT -5
Returns by calendar year on this crazy journey:
Dec 31, 2014 $28.20 Dec 31 2015 $7.25 (down 74.3%) Dec 30 2016 $3.18 (down 56.14%) Dec 29 2017 $2.32 (down 27%) Dec 31 2018 $1.06 (down 54.3%) Dec 31 2019 $1.29 (up 21.7%)
Dec 31, 2020 $3.13 (up 142%)
Dec 31, 2021 $4.37 (up 39.6%)
Dec 30, 2022 $5.27 (up 20.6%)
Dec 29, 2023 $3.64 (down 30.9%)2024 YTD: $5.53 (up 51.9%) S&P 500 Index Performance2023 26.29 2022 -18.11 2021 28.71 2020 18.40 2019 31.49 Russell 20002023 12.87% 2022 -15.51% 2021 24.40% 2020 9.82% 2019 27.94% NASDAQ2023 43.42% 2022 -33.10% 2021 21.39% 2020 43.64% 2019 35.23%
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Post by peppy on Jul 10, 2024 16:34:31 GMT -5
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Post by peppy on Jul 10, 2024 16:40:25 GMT -5
BD the green thing. cretin11I could go back and copy and paste the posts of paraphrasing "I do not like MNKD." "MNKD is not good." Scroll up. MNKD is up 51.9% year to date. Do you two need an eye doctor?
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