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Post by oldfishtowner on Jan 6, 2023 8:44:54 GMT -5
Maybe Castagna will shed some light on the clofazimine trial that was supposed to start by the end of 2022.
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Post by radgray68 on Jan 6, 2023 12:28:53 GMT -5
Was it JPM or Goldman Sachs that pulled coverage and said by going it alone we wouldn't reach profitability until 2023? I remember being really pissed at them for saying that (must be short, right? ha ha) Well, fast forward to today and holy cow those guys knew their stuff. Jason from Goldman asked in a conference call, when Sanofi could pull their contract? Goldman knew either catch and kill, or insurance coverage kill. do you remember the question? he asked it a second time on a subsequent conference call. That strikes a chord. Hard to believe I've forgotten but now that you remind me that WAS the way it went down. Talk about a key moment in the history of Mannkind. JPM should be really good for us. The big guys need to be shown we're not just a one trick pony anymore. Like always, I'm probably putting too much hope on each event along this journey. But I don't care. I can't wait. Happy Friday all. |
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Post by sayhey24 on Jan 6, 2023 13:26:56 GMT -5
I always put too much hope on these events and I have always been disappointed. My New Year's resolution is not for MNKD to disappoint. A nice plan outlining the small potatoes and the big potatoes like afrezza T2 and TS GLP1 would make me happy. I saw the below article last week and thought - when did we first start talking about Mounjaro on this board? If Mike wants to pop the stock all he needs to do is announce a GLP1 partnership for TS. Who wants to inject a weight loss drug when they can inhale? Of course a real afrezza T2 plan and partnership would really make me happy. www.nbcnews.com/health/health-news/weight-loss-drug-affordability-rcna60422 |
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Post by phdedieu12 on Jan 6, 2023 22:49:53 GMT -5
Don't kid yourself, you'll always be disappointed by one thing or another....
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Post by mymann on Jan 6, 2023 23:42:52 GMT -5
I'm hoping Mike would bring some good news during the JPMORGAN conference. Something substantial to get wall street to give mnkd some respect. Alfred Mann deserves to be recognized as a brilliant innovator and inventor. Just hoping but than again it's mnkd, the step child of biotechnology.
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Post by phdedieu12 on Jan 8, 2023 21:45:12 GMT -5
I think that simply being at the conference is good news in itself. Mannkind had become too big for HC Wainwright, and this should bring some new blood and larger/different investors. And as a side note, Al Mann is already recognized as a brilliant mind and inventor, and having two FDA approved drugs reinforces that. Let's see how many more Mannkind can push to the finish line
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Post by oldfishtowner on Jan 9, 2023 10:06:50 GMT -5
Just keep in mind it is not just technosphere that is responsible for the performance of Tyvaso DPI but also the inhaler design. Obviously a work of art!
Also, makes you wonder why MNKD decided to spend the investment of time and money on clinical trials with the clofazimine nebulizer and not go directly to the DPI version. The whole point it seems to me is having a delivery method that requires less drug to achieve the necessary efficacy in order to minimize side effects . So why even bother with the nebulizer when you know that the technosphere clofazimie will provide more efficient delivery of the drug?
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Post by anderson on Jan 9, 2023 10:33:40 GMT -5
Just keep in mind it is not just technosphere that is responsible for the performance of Tyvaso DPI but also the inhaler design. Obviously a work of art!
Also, makes you wonder why MNKD decided to spend the investment of time and money on clinical trials with the clofazimine nebulizer and not go directly to the DPI version. The whole point it seems to me is having a delivery method that requires less drug to achieve the necessary efficacy in order to minimize side effects . So why even bother with the nebulizer when you know that the technosphere clofazimie will provide more efficient delivery of the drug?
clofazimine nebulizer was already in progress when they acquired QrumPharma DEC of 2020(“This acquisition brings us a lead program that is expected to enter Phase 1 in late 2021"). They could have reformulated and spent 1 year and about 10 mil or so on the R&D, so we would have just entered phase 1, instead we are getting ready for phase 2. |
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Post by sayhey24 on Jan 9, 2023 11:43:37 GMT -5
Just keep in mind it is not just technosphere that is responsible for the performance of Tyvaso DPI but also the inhaler design. Obviously a work of art!
Also, makes you wonder why MNKD decided to spend the investment of time and money on clinical trials with the clofazimine nebulizer and not go directly to the DPI version. The whole point it seems to me is having a delivery method that requires less drug to achieve the necessary efficacy in order to minimize side effects . So why even bother with the nebulizer when you know that the technosphere clofazimie will provide more efficient delivery of the drug?
clofazimine nebulizer was already in progress when they acquired QrumPharma DEC of 2020(“This acquisition brings us a lead program that is expected to enter Phase 1 in late 2021"). They could have reformulated and spent 1 year and about 10 mil or so on the R&D, so we would have just entered phase 1, instead we are getting ready for phase 2. I would hope they would have done some due diligence prior to the acquisition to validate clofazimine works with technosphere. If it does I would think going straight to phase 1s with TS would be the better approach even if it adds some time. If TS does not work then I would question what Mike is doing. I will be waiting to hear his update on V-Go and what he thinks his plan is on this. With afrezza selling for $35 on Medicare it raises more questions on V-Go so lets see his plan. I am hoping some partner movement on afrezza for T2s is happening and Mike discusses. I also hope someone asks about the TS GLP1 patent which they recently got and what their plans are for this. If TS GLP1 is real it would be huge. We know the patent is real. Hopefully Mike will at least address the patent especially now when there is talk of Mounjaro becoming the greatest selling drug of all time. |
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Post by Clement on Jan 9, 2023 12:05:18 GMT -5
Just keep in mind it is not just technosphere that is responsible for the performance of Tyvaso DPI but also the inhaler design. Obviously a work of art!
Also, makes you wonder why MNKD decided to spend the investment of time and money on clinical trials with the clofazimine nebulizer and not go directly to the DPI version. The whole point it seems to me is having a delivery method that requires less drug to achieve the necessary efficacy in order to minimize side effects . So why even bother with the nebulizer when you know that the technosphere clofazimie will provide more efficient delivery of the drug?
clofazimine nebulizer was already in progress when they acquired QrumPharma DEC of 2020(“This acquisition brings us a lead program that is expected to enter Phase 1 in late 2021"). They could have reformulated and spent 1 year and about 10 mil or so on the R&D, so we would have just entered phase 1, instead we are getting ready for phase 2. Yes. And I'd like to mention that UTHR did the INCREASE study (PH-ILD) with Tyvaso-nebulizer. Then FDA approved Tyvaso-nebulizer and Tyvaso-DPI for PH-ILD. Maybe something similar could happen with cofazimine. |
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Post by phdedieu12 on Jan 9, 2023 12:11:18 GMT -5
clofazimine nebulizer was already in progress when they acquired QrumPharma DEC of 2020(“This acquisition brings us a lead program that is expected to enter Phase 1 in late 2021"). They could have reformulated and spent 1 year and about 10 mil or so on the R&D, so we would have just entered phase 1, instead we are getting ready for phase 2. I would hope they would have done some due diligence prior to the acquisition to validate clofazimine works with technosphere. If it does I would think going straight to phase 1s with TS would be the better approach even if it adds some time. If TS does not work then I would question what Mike is doing. I will be waiting to hear his update on V-Go and what he thinks his plan is on this. With afrezza selling for $35 on Medicare it raises more questions on V-Go so lets see his plan. I am hoping some partner movement on afrezza for T2s is happening and Mike discusses. I also hope someone asks about the TS GLP1 patent which they recently got and what their plans are for this. If TS GLP1 is real it would be huge. We know the patent is real. Hopefully Mike will at least address the patent especially now when there is talk of Mounjaro becoming the greatest selling drug of all time. There are no reasons whatsoever to validate that any molecule work with TS. The point is to find molecule that would fit a profile and THEN see if they can be improved with TS (exactly how it was done with Tyveso). Mannkind has focused on orphan drugs, clofazimine seems like a great candidate for an ailment that technically has no treatment, outside of a cocktail of drugs with terrible side effects and now we develop it. And let's be honest, you question everything Mike is doing, that's what you do! As a matter of fact I wonder if there is anything Mike has done that you haven't questioned. |
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Post by sayhey24 on Jan 9, 2023 12:53:57 GMT -5
PHD - You are correct, I do question everything Mike does. I would hope every shareholder does. Don't you? I do not believe there is anything Mike has done which I have not questioned. If I remember correctly I was one of the few shareholders a few years back during the Christmas surprise when many questioned Mike and were pretty upset at him. I 100% believed MNKD made the right move getting the additional cash and Mike got my full support.
When I see what seems to me to be a boneheaded move like buying V-Go, I will question it. Hopefully Mike can lay out a plan and execute on it where he demonstrates he was indeed correct and I was wrong. With $35 Medicare afrezza, what is the V-Go plan?
Doing trials with a nebulizer when you can go straight to TS makes me scratch my head. Sitting on TS GLP1 and never submitting the patent until there is message board chatter also makes me scratch my head. Having afrezza for T2s sitting on the shelf for 3+ years makes me hit my head against the wall.
We are now 7 years into this relationship with Mike and things have moved very very slowly. Its a new year so lets see what he can get done. He maybe sitting on 2 drugs which have the potential of being some of the greatest selling drugs of all time. Lets also be honest, not much has happened in seven years with afrezza nor TS GLP1. Tyvaso DPI is clearly a big win and 2023 needs to be the year he starts building on this big win with bigger wins.
Your comment that "There are no reasons whatsoever to validate that any molecule work with TS" is a head scratcher. That use to always be step 1 to see if the molecule will proper fly and get into the deep lung. If you look at the UTHR slides and the two slides with the lungs - that is what they are showing - deep lung penetration.
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Post by phdedieu12 on Jan 9, 2023 14:23:05 GMT -5
I guess this is where we differ. To question everything Mike does suggests you know everything Mike does, which you don't and can't possibly know. Subsequently, questioning all that you can't possibly know intimates you somewhat or completely disagrees with anything/everything he does, otherwise you'd simply agree or disagree with his decisions. As a shareholder, I don't have time to follow his every move/decision, I am glad you do. And I certainly don't know enough to opine on his every move/decision, and again I am glad you do. And when I have questions, I simply ask questions until I am satisfied with the answer. And if I don't like the answer, I sell my position: this is what this shareholder does!
As far as V-Go is concerned while you may not like the acquisition, it was pretty straight forward: Great price for the product, pays for itself within 1-2 years, gives reps 2 reasons to meet endos. Keep in mind it is the end result that validate the assumption. For anyone to be right or wrong you have to establish what your intended result is. Here is your opportunity to tell us how Mike was wrong (and why)!
You're simply making an awful lot of assumptions (too many in my opinion), and maybe it's stimulating to imagine what could be, but again how do you know they're sitting on a patent, why not pause and consider there is a pretty good reason we're simply not privy to? I do agree that I wish things went "faster", but each time you point out this "7 year relationship" you're also neglecting to consider that less than 5 years ago we were essentially bankrupt. The timeline to me reads more like this: 1-2 years spent surviving, 1-2 years building the foundation, 3-4 years to create and FDA approved drug and a strong pipeline, and now it doesn't seem so long anymore. Rome wasn't built in a day!
My comment, I concede, lacked clarity: You can't validate any molecule will work with TS in advance, that's where R&D comes in. My understanding is that all we can do is gamble (educated guesses) that certain drugs can be improved with TS. But if you have knowledge/examples to show that this indeed "use to always be step 1" then by all means, do tell. Considering we only have two candidates (Afrezza and Tyveso) this should be easy.
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Post by sayhey24 on Jan 9, 2023 15:01:31 GMT -5
I guess this is where we differ. To question everything Mike does suggests you know everything Mike does, which you don't and can't possibly know. Subsequently, questioning all that you can't possibly know intimates you somewhat or completely disagrees with anything/everything he does, otherwise you'd simply agree or disagree with his decisions. As a shareholder, I don't have time to follow his every move/decision, I am glad you do. And I certainly don't know enough to opine on his every move/decision, and again I am glad you do. And when I have questions, I simply ask questions until I am satisfied with the answer. And if I don't like the answer, I sell my position: this is what this shareholder does! As far as V-Go is concerned while you may not like the acquisition, it was pretty straight forward: Great price for the product, pays for itself within 1-2 years, gives reps 2 reasons to meet endos. Keep in mind it is the end result that validate the assumption. For anyone to be right or wrong you have to establish what your intended result is. Here is your opportunity to tell us how Mike was wrong (and why)! You're simply making an awful lot of assumptions (too many in my opinion), and maybe it's stimulating to imagine what could be, but again how do you know they're sitting on a patent, why not pause and consider there is a pretty good reason we're simply not privy to? I do agree that I wish things went "faster", but each time you point out this "7 year relationship" you're also neglecting to consider that less than 5 years ago we were essentially bankrupt. The timeline to me reads more like this: 1-2 years spent surviving, 1-2 years building the foundation, 3-4 years to create and FDA approved drug and a strong pipeline, and now it doesn't seem so long anymore. Rome wasn't built in a day! My comment, I concede, lacked clarity: You can't validate any molecule will work with TS in advance, that's where R&D comes in. My understanding is that all we can do is gamble (educated guesses) that certain drugs can be improved with TS. But if you have knowledge/examples to show that this indeed "use to always be step 1" then by all means, do tell. Considering we only have two candidates (Afrezza and Tyveso) this should be easy. I am going to save this post for Jan 2024 and we will see where we are at. I don't know everything Mike is doing nor do I care but I do know everything he is doing with regard to MNKD which is made public. That is what I am talking about and all I care about with regard to this board. Lets see what he says at this conference. Concerning TS and molecules there use to be no guessing. You bring in the molecule into the lab and you see what it does. I think it was Pfieffer who use to say 'give us your molecule and we will see if it flies". Maybe it was Hakan. Its been so long I don't remember. At one point one of those guys on a conference call made an open plea to anyone who knew of a molecule. How many they tested I have no idea but I do know several GLP1s were and our CMO at the time was very excited. You ask - How do I know they are sitting on a patent for TS GLP1? Mango posted it a month or so ago that it was awarded. My question is why did it take 15 years and message board discussion to even get the patent being applied for? My bigger question is what is the plan now that we have it? NBC news is saying Mounjaro could be the greatest selling drug of all time. Could TS GLP1 solve the 2 biggest issues Mounjaro has? Clearly it could solve the injection problem and Peter Richardson seemed to think TS could solve some of the digestive issues. You say "5 years ago we were essentially bankrupt." You are correct and based on today's afrezza sales we would be bankrupt today without Martine throwing MNKD a life line. As Mike said on a call - she asked how she could help when things looked really really bad in the summer of 2014. What T2 afrezza plan and sales have MNKD had since Mike's arrival in 2016??? For T1s the kids should save afrezza and turn the ship around but right now T1 sales are nothing to write home about after 7 years. What we do know is the flying hamburger did not fly. At least the spruce goose did. |
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Post by casualinvestor on Jan 9, 2023 20:09:26 GMT -5
I thought one of the benefits of V-Go was that is was a place to use more the insulin Mannkind has bought or is contracted to buy?
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