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Post by agedhippie on Sept 15, 2023 22:31:51 GMT -5
Tyvaso DPI VS Yutrepia Everyone knows what Tyvaso DPI is Yutrepia not so much. Ask me again when they actually have more than an idea to sell. What are you looking for? They have completed all the regulatory trials, FDA granted tentative approval, and a 24 month extension trial (if nothing else the lawsuits allowed for extended trials  ) so they have all the material for the medical world, and they have presented their finding at the 2023 American Thoracic Society. Yutrepia definitely exists and would be on sale now except for the UTHR lawsuits! |
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Post by letitride on Sept 16, 2023 3:00:27 GMT -5
I remember when Tyvaso DPI was an idea that could not be sold to. Tyvasso DPI is being sold and is being sold while doing more extended trials for more indications.đ
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Post by agedhippie on Sept 16, 2023 11:36:37 GMT -5
I remember when Tyvaso DPI was an idea that could not be sold to. Tyvasso DPI is being sold and is being sold while doing more extended trials for more indications.đ I feel like LQDA is slipstreaming behind UTHR in those trials. The PH-ILD trial is a good example; UTHR does the trial and LQDA argues equivalence and gets FDA approval for PH-ILD. UTHR gets a period of exclusivity (a year I think) so they get a lead in the market though (in the case of PH-ILD that exclusivity expires in March or May 2024). UTHR provide the perfect example of what to do when you get the basic approval - run other trials expanding the label which is what was never done with Afrezza. |
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Post by letitride on Sept 16, 2023 23:24:44 GMT -5
UTHR exclusivity duration will be known when Yutrepia is actually on the market. As for Afrezza those other trials are currently being run. Better late than never!
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Post by agedhippie on Sept 17, 2023 10:39:15 GMT -5
UTHR exclusivity duration will be known when Yutrepia is actually on the market. As for Afrezza those other trials are currently being run. Better late than never! The duration of the exclusivity for PH-ILD is known; it was granted in March 2021 and expires in March 2024 (I thought it was a 1 year grant from 2023, but it was 3 years from 2021) regardless of whether or not anyone enters the market. The trials Afrezza needs are those to change the label, and also prove superiority against GLP-1 for Type 2. The current approach from Mike at the conference is that they will align on the Type 1 market for Afrezza, and the Type 2 market for V-Go so combined with the switch in funding focus that's not going to happen. |
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Post by prcgorman2 on Sept 17, 2023 11:39:46 GMT -5
Iâll add the qualifier âsoonâ.
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Post by sayhey24 on Sept 17, 2023 14:51:48 GMT -5
Hmmmmm - "The trials Afrezza needs are those to change the label, and also prove superiority against GLP-1 for Type 2. The current approach from Mike at the conference is that they will align on the Type 1 market for Afrezza, and the Type 2 market for V-Go so combined with the switch in funding focus that's not going to happen."
I think we need more than just the label. I think we need T1 and T2 SoC changes. What I thought I heard Mike say was lets see the results from the 3 trials and then leverage those to focus future activity. It seems the kids trial is going better than expected but we will see. For the India trial Mike mentioned that he was expecting to see a 1.5 to 2.0 A1c drop. If he is right then that should put afrezza on par with GLP1s.
I am not sure we need GLP1 superiority. I think what we need is the study showing afrezza as an adder to GLP1s. As Mike said the GLP1s are good for 2 years and then they need the afrezza. I think its really going to come down to the sales strategy Mike wants to take in the T2 market. Its pretty clear V-Go is a no go and with $35 Medicare afrezza and the India results I would be shocked if Mike does not to change his T2 strategy. At this point its patience. Mike wants the other trial results before making additional trial moves. OK. I would do the GLP1/afrezza study but if Mike can 10X the pps in 2 years between Tyvaso DPI, afrezza and the pipeline I will be patient.
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Post by agedhippie on Sept 17, 2023 18:17:43 GMT -5
Hmmmmm - "The trials Afrezza needs are those to change the label, and also prove superiority against GLP-1 for Type 2. The current approach from Mike at the conference is that they will align on the Type 1 market for Afrezza, and the Type 2 market for V-Go so combined with the switch in funding focus that's not going to happen." I think we need more than just the label. I think we need T1 and T2 SoC changes. What I thought I heard Mike say was lets see the results from the 3 trials and then leverage those to focus future activity. It seems the kids trial is going better than expected but we will see. For the India trial Mike mentioned that he was expecting to see a 1.5 to 2.0 A1c drop. If he is right then that should put afrezza on par with GLP1s. I am not sure we need GLP1 superiority. I think what we need is the study showing afrezza as an adder to GLP1s. As Mike said the GLP1s are good for 2 years and then they need the afrezza. I think its really going to come down to the sales strategy Mike wants to take in the T2 market. Its pretty clear V-Go is a no go and with $35 Medicare afrezza and the India results I would be shocked if Mike does not to change his T2 strategy. At this point its patience. Mike wants the other trial results before making additional trial moves. OK. I would do the GLP1/afrezza study but if Mike can 10X the pps in 2 years between Tyvaso DPI, afrezza and the pipeline I will be patient. Don't take my word for it, as always read the transcript. Here is Mikes take on it; TLDR; We have done what we can with Afrezza, now we are focusing on the orphan lung market. How does he see the diabetes market? And bear in mind he knows what the India results look like. But V-Go itself has been a great device. We've positioned that for type 2, so I talked about Afrezza for type 1. We think that's going to be differentiating, and the GLPs aren't really going to majorly impact that...
and The type 2 market, most patients are still going to be basal bolus. V-Go has 90 plus percentage of its use in type 2. The majority of that is probably Medicare, maybe 60%, 70%. And that's where we really position our V-Go device.
So Type 2 = V-Go, Type 1 = Afrezza. But what is his vision for Mannkind? Not get Afrezza to a broader market, mine those veins of Afrezza gold, but; And so we really did pivot in 2019 to say, we are going to be fully focused on orphan lung, leverage our technology, help those patients
and And we really pivoted the whole company to focus on orphan lung with kind of diabetes optionality and Tyvaso DPI got approved last year.
(For context this was answering the question I asked - where do you see the future?) His view on Afrezza is that they have done what they can and that they won't discontinue it (he can't, he has his reputation to think), but And I think that's really where we are now as we feel the cash flow positivity, the investments we've made in diabetes will start to come off the P&L next year in terms of the research studies and then clofazimine will kick in and then the nintedanib kicks in.
Not saying they will expand the insulin label, or start any new trials beyond those announced. Rather there will be a switch to the pipeline. None of this is to say that what he is doing is wrong as he is incapable of selling Afrezza so taking a swing at a different target, "fully focused on orphan lung", makes sense for the company. However, it does mean you can forget about GLP-1 because every time he mentioned it he ran it down. |
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Post by letitride on Sept 17, 2023 18:25:33 GMT -5
UTHR exclusivity duration will be known when Yutrepia is actually on the market. As for Afrezza those other trials are currently being run. Better late than never! The duration of the exclusivity for PH-ILD is known; it was granted in March 2021 and expires in March 2024 (I thought it was a 1 year grant from 2023, but it was 3 years from 2021) regardless of whether or not anyone enters the market. The trials Afrezza needs are those to change the label, and also prove superiority against GLP-1 for Type 2. The current approach from Mike at the conference is that they will align on the Type 1 market for Afrezza, and the Type 2 market for V-Go so combined with the switch in funding focus that's not going to happen. Grants are nice but until Yutrepia enters the market TrepT is still exclusive to the market in my opinion. As for Afrezza I believe I heard Mike say he was waiting on results from ongoing trials to determine his next move in endocrine. |
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Post by sayhey24 on Sept 17, 2023 19:39:37 GMT -5
Hmmmmm - "The trials Afrezza needs are those to change the label, and also prove superiority against GLP-1 for Type 2. The current approach from Mike at the conference is that they will align on the Type 1 market for Afrezza, and the Type 2 market for V-Go so combined with the switch in funding focus that's not going to happen." I think we need more than just the label. I think we need T1 and T2 SoC changes. What I thought I heard Mike say was lets see the results from the 3 trials and then leverage those to focus future activity. It seems the kids trial is going better than expected but we will see. For the India trial Mike mentioned that he was expecting to see a 1.5 to 2.0 A1c drop. If he is right then that should put afrezza on par with GLP1s. I am not sure we need GLP1 superiority. I think what we need is the study showing afrezza as an adder to GLP1s. As Mike said the GLP1s are good for 2 years and then they need the afrezza. I think its really going to come down to the sales strategy Mike wants to take in the T2 market. Its pretty clear V-Go is a no go and with $35 Medicare afrezza and the India results I would be shocked if Mike does not to change his T2 strategy. At this point its patience. Mike wants the other trial results before making additional trial moves. OK. I would do the GLP1/afrezza study but if Mike can 10X the pps in 2 years between Tyvaso DPI, afrezza and the pipeline I will be patient. Don't take my word for it, as always read the transcript. Here is Mikes take on it; TLDR; We have done what we can with Afrezza, now we are focusing on the orphan lung market. How does he see the diabetes market? And bear in mind he knows what the India results look like. But V-Go itself has been a great device. We've positioned that for type 2, so I talked about Afrezza for type 1. We think that's going to be differentiating, and the GLPs aren't really going to majorly impact that...
and The type 2 market, most patients are still going to be basal bolus. V-Go has 90 plus percentage of its use in type 2. The majority of that is probably Medicare, maybe 60%, 70%. And that's where we really position our V-Go device.
So Type 2 = V-Go, Type 1 = Afrezza. But what is his vision for Mannkind? Not get Afrezza to a broader market, mine those veins of Afrezza gold, but; And so we really did pivot in 2019 to say, we are going to be fully focused on orphan lung, leverage our technology, help those patients
and And we really pivoted the whole company to focus on orphan lung with kind of diabetes optionality and Tyvaso DPI got approved last year.
(For context this was answering the question I asked - where do you see the future?) His view on Afrezza is that they have done what they can and that they won't discontinue it (he can't, he has his reputation to think), but And I think that's really where we are now as we feel the cash flow positivity, the investments we've made in diabetes will start to come off the P&L next year in terms of the research studies and then clofazimine will kick in and then the nintedanib kicks in.
Not saying they will expand the insulin label, or start any new trials beyond those announced. Rather there will be a switch to the pipeline. None of this is to say that what he is doing is wrong as he is incapable of selling Afrezza so taking a swing at a different target, "fully focused on orphan lung", makes sense for the company. However, it does mean you can forget about GLP-1 because every time he mentioned it he ran it down. The potential of afrezza dwarfs clofazimine and everything else in the pipeline. The problem is you can't keep doing the same thing over and over again. Its pretty clear MNKD did not have a clue how to sell afrezza. Hiring and firing and hiring and firing sales reps was not going to do it. Putting flying hamburger commercials on TV was not going to do it and neither was Damon Dash. Yes up until a year ago Mike was incapable of selling afrezza into the T2 market. The good news is one huge thing has changed and at the same time he has new T2 trial data showing up from India pretty soon. Mike's pipeline is fine but $35 Medicare afrezza is a game changer for selling afrezza into the T2 market. As Mike said lets see what the existing trial results are. For 9 years MNKD has been trying to figure out how to sell afrezza. When Mike bought V-Go he had given up on the T2s with afrezza. He had put afrezza on the shelf for years already for the T2s. V-Go was the great hope he could redirect the board and the shareholders with the T2 market and get "Most" of them off his back. The reality is he just needs to keep telling that story for now. V-Go was his baby but when the India results come in things can change. Combine great India results with $35 insulin where CMS is picking up the tab and not MNKD with the senior saver model. Now we have a new ball game. Of course if the India results suck then we have the kids and T1s and the pipeline and V-Go can die a slow death. I think this was the first time I heard him publicly say GLP1s buy the T2 two years and then they need the afrezza. Yep, he is right. I think we have said the same thing here for years. You also can't sell against GLP1 weight loss but you can add the afrezza early and often and you can get the Medicare CGM. At this point we need to see the India data and then do the afrezza/GLP1 adder trial . If Mike is right with the 1.5 to 2.0 reduction we are off to the races. The great news is Tyvaso DPI is paying the bills and doing better than most expected. So much so Mike is now talking about 10X-ing the pps with afrezza and the pipeline. A few short years ago he was trying to figure out what door to put the "Out of Business" sign on. |
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Post by prcgorman2 on Sept 18, 2023 7:17:07 GMT -5
I continue to believe that selling Afrezza is not a marketing problem. Persons With Diabetes (PWDs) do not choose which medications are prescribed to them: their doctorâs do. The doctors are taught what to prescribe. What changes that is labor, time, and money. I am guessing that everyone at MannKind is suffering Afrezza fatigue, and unendingly grateful to be manufacturing and selling Tyvaso DPI, a drug which is outpacing original sales estimates. They want more wins under their belt, and orphan lung diseases are a sweet spot given the size and maturity of MannKind. Will Afrezza ever reach the status so many of us assumed was assured? Perhaps, but additional investment has to be success-based where âsuccessâ can be a mix of trial results and correspondingly improved sales results. Thatâs business.
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Post by letitride on Sept 18, 2023 7:56:15 GMT -5
Afrezza the fastest acting insulin has a time and a place it has not yet met. Its coming and its the beast that Al believed it to be. Mike is handling this well pushing forward with the rest of the pipeline waiting for the right time to unleash the beast in my opinion. $100 stock
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Post by agedhippie on Sept 18, 2023 8:20:21 GMT -5
I continue to believe that selling Afrezza is not a marketing problem. Persons With Diabetes (PWDs) do not choose which medications are prescribed to them: their doctorâs do. The doctors are taught what to prescribe. What changes that is labor, time, and money. I am guessing that everyone at MannKind is suffering Afrezza fatigue, and unendingly grateful to be manufacturing and selling Tyvaso DPI, a drug which is outpacing original sales estimates. They want more wins under their belt, and orphan lung diseases are a sweet spot given the size and maturity of MannKind. Will Afrezza ever reach the status so many of us assumed was assured? Perhaps, but additional investment has to be success-based where âsuccessâ can be a mix of trial results and correspondingly improved sales results. Thatâs business. I think there are two different markets, the Type 1 market which is often far more opinionated (my doctor will defer to me if I press) and the Type 2 market where the SoC is far more rigidly followed. This is largely the result of Type 1 being handled by specialists, endos, and Type 2 being seen as less serious and handled by PCPs. This is not a knock on PCPs but rather the result of being able to focus on one topic rather than the whole gamut of medicine. In that case having a standard of care makes perfect sense since it piggybacks on the work done by the endos. That was an incredibly long winded way of saying some PWD do get to chose their medication! I think Afrezza will continue to steadily climb at the current rate. There will be a step up when it becomes available to kids as they get onboarded and then it will continue to the current rate. The Type 2 market will be left as it is. Reading the transcript Mike's take on this is that MNKD need the infrastructure for the expansion so Afrezza effectively becomes a marginal cost; And so, I think when you look out there part of people say, why do you still have Afrezza? Well, part of it is you need a marketing team, you need a sales operations team, you need data integration teams, IT. We have all that infrastructure now. So while one could say, I can get rid of some of those expenses at the end of the day, if we're going to be launching two, three, four products, we need all that backbone infrastructure. |
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Post by uvula on Sept 18, 2023 8:21:13 GMT -5
All this afrezza talk is off topic for this thread. But I can't resist jumping in.
Some of you sound delusional. MC has said things that indicate that he has given up on pursuing afrezza for T2D. If the CEO of the company is not on board it is not going to happen.
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Post by agedhippie on Sept 18, 2023 8:26:46 GMT -5
All this afrezza talk is off topic for this thread. But I can't resist jumping in. Some of you sound delusional. MC has said things that indicate that he has given up on pursuing afrezza for T2D. If the CEO of the company is not on board it is not going to happen. No thread stays on topic beyond the first page  |
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) so they have all the material for the medical world, and they have presented their finding at the 2023 American Thoracic Society. Yutrepia definitely exists and would be on sale now except for the UTHR lawsuits!
