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Post by rockstarrick on Nov 2, 2016 15:51:53 GMT -5
To use your sailing analogy, Afrezza hasn't even been able to leave the port without taking on water, let alone make a trans Atlantic float. It might sail before it's over but based on what we've seen over the past year and a half, I'm not sure how anyone could be so sure. The Titanic was unsinkable remember? I do admire your constant optimism though.  My fear is that this ship will not sail ... but the cargo will go out in a different ship.  Read more: mnkd.proboards.com/thread/6598/different-approach?page=1#ixzz4OszQN4OsFollow the link, then scroll down until you find Alfred Mann, I believe the # you will find is 153.2 million shares, you actually believe the people that now control these shares will let a different ship sail without us, they are us, right ?? Can anybody comment on this, I'm just sharing the # #dontbuyorsale data.cnbc.com/quotes/MNKD/tab/8((((((((((KABOOM !!!)))))))))) fyi |
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Post by goyocafe on Nov 2, 2016 15:56:30 GMT -5
Follow the link, then scroll down until you find Alfred Mann, I believe the # you will find is 153.2 million shares, you actually believe the people that now control these shares will let a different ship sail without us, they are us, right ?? Can anybody comment on this, I'm just sharing the # #dontbuyorsale data.cnbc.com/quotes/MNKD/tab/8((((((((((KABOOM !!!)))))))))) fyi My only concern is a back door deal, BK where they bid on the assets, or something else that kicks most of us to the street, but not them. |
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Post by mnholdem on Nov 2, 2016 16:01:06 GMT -5
Gtay - that depends on the label update. I read through FDA section 314.70 today, which deals with supplements to an already approved drug. I don't have it in front of me (actually I'm sitting in a bar enjoying a Sam Adams OktoberFest while my new tires are being installed across the street) but it covers changes requiring approval by the FDA. Some are called "moderate" and can implemented in 30 days. Dosing, medication guide and similar changes are covered. I suspect that the newest PK/PD graphs and charts related new onset and duration data will be approved quickly. Language related to post-meal adjustments leading to a reduction of hypoglemic excursions may take a while longer.
Even these simple changes will enable the area sales /business managers to point out some differences between Afrezza and RAA insulin competition. Afrezza is fast in / fast out and post meal adjustments have been proven to improve control of BG with low risk of hypo. As the label currently stands, sales & marketing has not been permitted by the FDA to say anything about the new post market trial data. I think that may be about to change...
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Post by rockstarrick on Nov 2, 2016 16:03:05 GMT -5
Follow the link, then scroll down until you find Alfred Mann, I believe the # you will find is 153.2 million shares, you actually believe the people that now control these shares will let a different ship sail without us, they are us, right ?? Can anybody comment on this, I'm just sharing the # #dontbuyorsale data.cnbc.com/quotes/MNKD/tab/8((((((((((KABOOM !!!)))))))))) fyi My only concern is a back door deal, BK where they bid on the assets, or something else that kicks most of us to the street, but not them. Those are common shares, right ?? I'm not sure that would work. |
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Post by Deleted on Nov 2, 2016 16:03:53 GMT -5
I think it is also safe to say (which I did about 5-7 weeks ago) that MannKind management already is actively pursuing the label change(s). I posted that they were planning multiple submissions (this information came from their Investor Relations department) and that some would be simple (typically 30-day) reviews while submissions related to efficacy would take longer. The CEO also mentioned label change applications were planned for late September at the last investors conference. If they met their timetable and got the submittals to the FDA, we should be hearing about it soon. A better label = better, more effective sales & marketing at both the physicians and patients. Investor Relations stated that there would be an update on label submissions at the Nov 9 earnings call. A better label will take the litigation fear out of the picture which is a concern from the few endos I spoke with. |
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Post by bioexec25 on Nov 2, 2016 16:05:46 GMT -5
Rockstar that's a bunch of shares even if directionally accurate. 25-30% ish. $75mil current value and $450mil value even at 3. Yeah they will do what they can. At $3 that's like a 1.6 billion BO. They shouldn't be happy with that. I still think they may prop it up or hold out more likely for $3bil or $6 pps minimum. Fund it for a year and go for twice that. Normally for the foundation or associated entities that may be a lot of money but at .40 a share it's far more attractive. Many of Al's friends probably holding at north of $5 right now. Perhaps motivation, albeit fleeting if no signs of script growth, to give them a soft or limited hard landing versus a firery crash with no survivors.
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Post by rockstarrick on Nov 2, 2016 16:19:00 GMT -5
I think it is also safe to say (which I did about 5-7 weeks ago) that MannKind management already is actively pursuing the label change(s). I posted that they were planning multiple submissions (this information came from their Investor Relations department) and that some would be simple (typically 30-day) reviews while submissions related to efficacy would take longer. The CEO also mentioned label change applications were planned for late September at the last investors conference. If they met their timetable and got the submittals to the FDA, we should be hearing about it soon. A better label = better, more effective sales & marketing at both the physicians and patients. Investor Relations stated that there would be an update on label submissions at the Nov 9 earnings call. A better label will take the litigation fear out of the picture which is a concern from the few endos I spoke with. I think you two jumped threads !!🎯 |
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Post by rockstarrick on Nov 2, 2016 16:20:31 GMT -5
Rockstar that's a bunch of shares even if directionally accurate. 25-30% ish. $75mil current value and $450mil value even at 3. Yeah they will do what they can. At $3 that's like a 1.6 billion BO. They shouldn't be happy with that. I still think they may prop it up or hold out more likely for $3bil or $6 pps minimum. Fund it for a year and go for twice that. Normally for the foundation or associated entities that may be a lot of money but at .40 a share it's far more attractive. Many of Al's friends probably holding at north of $5 right now. Perhaps motivation, albeit fleeting if no signs of script growth, to give them a soft or limited hard landing versus a firery crash with no survivors. That sure makes sense to me. Thank you for the comment. |
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Post by matt on Nov 2, 2016 16:53:20 GMT -5
My only concern is a back door deal, BK where they bid on the assets, or something else that kicks most of us to the street, but not them. Those are common shares, right ?? I'm not sure that would work. My understanding is that the various Mann entities own plain vanilla common shares and, as such, have no more rights than any shareholder that owns just 1 share.
However, the issue as we all know is the need for cash to keep operating, whether in or out of bankruptcy. If a company is BK, it can obtain what is known as "debtor in possession (DIP) financing" with the approval of the court, and that debt becomes a priority claim (i.e. one that takes precedence over all other claims except certain items specified by law). A DIP financier can agree to give up rights to repayment in exchange for all of the common stock in the reorganized company, allowing the cash to be used to pay off creditors and effectively wiping out the existing common. However, if somebody wanted to play hard ball and grab Afrezza there are better, faster, and cleaner ways to get rid of the other shareholders while keeping the key creditors happy. What is clear is that no matter what happens those parties who put in significant "new money" can control the case, to the detriment of those who don't contribute cash. If the Mann entities don't or can't pony up new cash, they will have the same fate as all other shareholders.
As the company gets to a more critical point in their financing, the leverage goes to those with money. As time passes it will be increasingly hard to persuade an entity to contribute serious cash to run the company in exchange for a percentage of the ownership, when they can just wait some weeks or months until bankruptcy becomes inevitable and own 100% of the company free of debt and other claims. That is why next week's earnings release will be important as that will give us a good look a the balance sheet, burn rate, and remaining credit facilities. Unfortunately, the vultures will be looking at the same figures and drawing their own conclusions. |
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Post by rockstarrick on Nov 2, 2016 17:05:57 GMT -5
Those are common shares, right ?? I'm not sure that would work. My understanding is that the various Mann entities own plain vanilla common shares and, as such, have no more rights than any shareholder that owns just 1 share.
However, the issue as we all know is the need for cash to keep operating, whether in or out of bankruptcy. If a company is BK, it can obtain what is known as "debtor in possession (DIP) financing" with the approval of the court, and that debt becomes a priority claim (i.e. one that takes precedence over all other claims except certain items specified by law). A DIP financier can agree to give up rights to repayment in exchange for all of the common stock in the reorganized company, allowing the cash to be used to pay off creditors and effectively wiping out the existing common. However, if somebody wanted to play hard ball and grab Afrezza there are better, faster, and cleaner ways to get rid of the other shareholders while keeping the key creditors happy. What is clear is that no matter what happens those parties who put in significant "new money" can control the case, to the detriment of those who don't contribute cash. If the Mann entities don't or can't pony up new cash, they will have the same fate as all other shareholders.
As the company gets to a more critical point in their financing, the leverage goes to those with money. As time passes it will be increasingly hard to persuade an entity to contribute serious cash to run the company in exchange for a percentage of the ownership, when they can just wait some weeks or months until bankruptcy becomes inevitable and own 100% of the company free of debt and other claims. That is why next week's earnings release will be important as that will give us a good look a the balance sheet, burn rate, and remaining credit facilities. Unfortunately, the vultures will be looking at the same figures and drawing their own conclusions. Thanks Matt |
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Post by gamblerjag on Nov 2, 2016 18:10:59 GMT -5
I'm still in the camp that believes 1.6 or 3 billion is not going to happen. I believe we will live to see MNKD corp late 2017 and 2018 .. from then on who knows if it gets bought or they get enough traction they can go alone / with partners. I don't believe Matt's epic or Mikes " you'll thank me later" are just empty words. If this company ever gets sold whether in late 2017 or early 2018 (if at all) I say we don't get less than 8 billion/$15 pps -Afrezza/ Techno/Epi/RLS/U.S. parnter/ other countries... i still think we will be pleasantly suprised.
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Post by falconquest on Nov 2, 2016 20:48:34 GMT -5
I'm still in the camp that believes 1.6 or 3 billion is not going to happen. I believe we will live to see MNKD corp late 2017 and 2018 .. from then on who knows if it gets bought or they get enough traction they can go alone / with partners. I don't believe Matt's epic or Mikes " you'll thank me later" are just empty words. If this company ever gets sold whether in late 2017 or early 2018 (if at all) I say we don't get less than 8 billion/$15 pps -Afrezza/ Techno/Epi/RLS/U.S. parnter/ other countries... i still think we will be pleasantly suprised. I would like to be as enthusiastic gambler but for more than ten years this company has been one disappointment after another. I have finally reached a point where I realized I had to set my faith in the company and product aside and view things how they really are. Something has to happen here. Either they find a way to keep this company alive or it goes down in flames. Quite frankly, I am more comfortable sitting on the sidelines right now waiting for consistent positive news. I certainly hope you are right in your predictions. Right now though it doesn't look feasible. |
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Post by gtay87 on Nov 2, 2016 22:21:17 GMT -5
I think it is also safe to say (which I did about 5-7 weeks ago) that MannKind management already is actively pursuing the label change(s). I posted that they were planning multiple submissions (this information came from their Investor Relations department) and that some would be simple (typically 30-day) reviews while submissions related to efficacy would take longer. The CEO also mentioned label change applications were planned for late September at the last investors conference. If they met their timetable and got the submittals to the FDA, we should be hearing about it soon. A better label = better, more effective sales & marketing at both the physicians and patients. Investor Relations stated that there would be an update on label submissions at the Nov 9 earnings call. A better label will take the litigation fear out of the picture which is a concern from the few endos I spoke with. Until they actually apply for a change which specifies exactly what kind of change they are seeking, no one knows one way or another. |
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Post by mnkdnut on Nov 2, 2016 23:10:51 GMT -5
I get why Castagna is targeting Endo's with Afrezza. Sanofi supposedly did the same. We have all seen evidence here that shows some Endo's slow to prescribe Afrezza. We're not in a situation where we can wait for them to wake up. Does it make sense at some point to abandon this marketing strategy and go right to the consumer? In other words, let's drive this the other direction. Market directly to diabetics and make resources available to Endo's to serve their patients. We don't have time to waste here. We need to move product! What are you going to say to the Type 1s in a DTC campaign that will make them move against the advice of their endos? Any case you could make that would move a Type 1 will also move and endo and vice versa. Let me tell you what will not do it - no more needles. What might do it, better performance and fewer hypos - but the label and trial data means you cannot say that. Now somebody is going to say what about the early adopters and their CGMS? Short answer - nobody cares, you can get sub-6.0 on MDI if you put in the work so the assumption is their Afrezza results are due to the work and not the drug. To change that perception you need solid trial data and an ensuing label change. Without that, and I think it is safe to say that will not happen any time soon, Mannkind are pursuing the best and probably only approach that they can which is to win over endos one by one. Aged: what's your thought on how endos would respond to a label change that would allow claims of faster onset and faster exit? Would it make them any more open to prescribe, or will they remain adamant on Trial results that show it actually makes a clinical outcomes difference vs. RAA? Looks to me like the consumer/patient marketing campaign using "Outsilin" is banking on such a label improvement to make an impact. IMO, with endos dug in with conservatism due to the current label, the only real catalysts I see on the horizon are a solid pediatric trial and possibly Vdex expansion. |
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Post by agedhippie on Nov 3, 2016 7:12:56 GMT -5
Aged: what's your thought on how endos would respond to a label change that would allow claims of faster onset and faster exit? Would it make them any more open to prescribe, or will they remain adamant on Trial results that show it actually makes a clinical outcomes difference vs. RAA? Looks to me like the consumer/patient marketing campaign using "Outsilin" is banking on such a label improvement to make an impact. IMO, with endos dug in with conservatism due to the current label, the only real catalysts I see on the horizon are a solid pediatric trial and possibly Vdex expansion. A label change will make a little difference but for the most part it is going to take trial data. The big one is the lung trials - if those go well that will remove the bulk of the resistance. The problem for endos at the moment is that although Afrezza has marginally worse HbA1c results than RAA they could overlook that if it wasn't for the lung aspect. |
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