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Post by suebeeee1 on Nov 17, 2015 20:45:02 GMT -5
Obviously, I love your valuation. And, my guess is that many other funds are leaning towards a valuation that is much, much higher than the present $2.25/share. With all the patents MNKD holds, it should be worth something! Have you ever read Peter Thiel? He's one of the founders of paypal, very aggressive start up guy. To sum him up in brief, two points: 1. A business is worth the entire sum of future income.2. The only business you want to be in should be a monopoly. Something nobody else has.For many of us, that is MNKD.... my only concern being the monopoly part... there are other particle inhalation companies in hot pursuit of their own inhalation systems, and it won't be long before TS is challenged (but, still, there will be years-long lags in safety and regulatory aspects). I've read Thiel in regards to other subjects. And I've followed him since his early pay pal days. If he would value MNKD, the same way, who am I to argue?. Clearly, I like this valuation and that is how I got my tag of "exuberant pumper". The monopoly is the most valuable thing in my eyes... Besides how well Afrezza works for those we love!
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Post by jpg on Nov 17, 2015 21:47:43 GMT -5
60 days of June 2105? That is obviously long gone. Not certain what you are thinking? Certainly not thinking, sorry, jpg! Back and forth between loan documents and the board, overwhelming for this old guy!! Anyway, with the understanding you may have explained it, how did you conclude that March 2016 seems to be the date by which a decision must be made on the trial? Simply because that the date that has been given and I would guess that this is as late as the FDA will permit without calling them non complant (or whatever term they use to say you are stalling). Could Sanofi push that back? Historically that was almost standard and the drug makers simply become non complaint or something like that but there seems to be greater emphasis on sticking to the timelines now. What are the penalties for not doing this? With the recent focus on 'issues' with the pharma industry (Valeant and Shkreli...) will the FDA have more power to enforce these phase 4 trials? Will BPs feel more obligated to do them? I think the answer is probably yes. A 2000 letter that explains the status quo of the phase 4 system a few years ago: www.citizen.org/hrg1520A 2007 update (a bit longer but much better explanation): www.ncbi.nlm.nih.gov/pmc/articles/PMC2651713/ Basically who would do a 100-200 million $ trial to prove a drug may be safe to the lungs if it isn't selling? The trial would have to hit the points discussed in this article and at the same time help position the drug to be a big deal. The final reference I would give: www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/ Do notice that the type of trial being mandated by the FDA and those discussed in this paper are very different (and we have the much much more expensive varient of trial to do: the FDA really did a job on Mannkind with the label, black box and this phase 4 trial. Long answer short: I don't know what will happen come spring 2016...
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Post by oldfishtowner on Nov 17, 2015 23:16:23 GMT -5
Certainly not thinking, sorry, jpg! Back and forth between loan documents and the board, overwhelming for this old guy!! Anyway, with the understanding you may have explained it, how did you conclude that March 2016 seems to be the date by which a decision must be made on the trial? Simply because that the date that has been given and I would guess that this is as late as the FDA will permit without calling them non complant (or whatever term they use to say you are stalling). Could Sanofi push that back? Historically that was almost standard and the drug makers simply become non complaint or something like that but there seems to be greater emphasis on sticking to the timelines now. What are the penalties for not doing this? With the recent focus on 'issues' with the pharma industry (Valeant and Shkreli...) will the FDA have more power to enforce these phase 4 trials? Will BPs feel more obligated to do them? I think the answer is probably yes. A 2000 letter that explains the status quo of the phase 4 system a few years ago: www.citizen.org/hrg1520A 2007 update (a bit longer but much better explanation): www.ncbi.nlm.nih.gov/pmc/articles/PMC2651713/ Basically who would do a 100-200 million $ trial to prove a drug may be safe to the lungs if it isn't selling? The trial would have to hit the points discussed in this article and at the same time help position the drug to be a big deal. The final reference I would give: www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/ Do notice that the type of trial being mandated by the FDA and those discussed in this paper are very different (and we have the much much more expensive varient of trial to do: the FDA really did a job on Mannkind with the label, black box and this phase 4 trial. Long answer short: I don't know what will happen come spring 2016... Based on your third reference, I don't think this is a phase 4 study. As you say, it is different than what is described in the reference, i.e., a post-marketing surveillance study It is likely a phase 3 study because it is a randomized controlled clinical study. This is what is needed for a label change. I also agree with your comment: "Basically who would do a 100-200 million $ trial to prove a drug may be safe to the lungs if it isn't selling? The trial would have to hit the points discussed in this article and at the same time help position the drug to be a big deal." This is why I think the trial will address more than what the FDA is requiring and will be designed to show superiority.
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Post by jpg on Nov 18, 2015 0:18:43 GMT -5
Simply because that the date that has been given and I would guess that this is as late as the FDA will permit without calling them non complant (or whatever term they use to say you are stalling). Could Sanofi push that back? Historically that was almost standard and the drug makers simply become non complaint or something like that but there seems to be greater emphasis on sticking to the timelines now. What are the penalties for not doing this? With the recent focus on 'issues' with the pharma industry (Valeant and Shkreli...) will the FDA have more power to enforce these phase 4 trials? Will BPs feel more obligated to do them? I think the answer is probably yes. A 2000 letter that explains the status quo of the phase 4 system a few years ago: www.citizen.org/hrg1520A 2007 update (a bit longer but much better explanation): www.ncbi.nlm.nih.gov/pmc/articles/PMC2651713/ Basically who would do a 100-200 million $ trial to prove a drug may be safe to the lungs if it isn't selling? The trial would have to hit the points discussed in this article and at the same time help position the drug to be a big deal. The final reference I would give: www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/ Do notice that the type of trial being mandated by the FDA and those discussed in this paper are very different (and we have the much much more expensive varient of trial to do: the FDA really did a job on Mannkind with the label, black box and this phase 4 trial. Long answer short: I don't know what will happen come spring 2016... Based on your third reference, I don't think this is a phase 4 study. As you say, it is different than what is described in the reference, i.e., a post-marketing surveillance study It is likely a phase 3 study because it is a randomized controlled clinical study. This is what is needed for a label change. I also agree with your comment: "Basically who would do a 100-200 million $ trial to prove a drug may be safe to the lungs if it isn't selling? The trial would have to hit the points discussed in this article and at the same time help position the drug to be a big deal." This is why I think the trial will address more than what the FDA is requiring and will be designed to show superiority. Semantics maybe but a post approval study is a phase 4. I guess if you change the patient population you are targeting (new approval) than you could be back at being a phase 3 but in this case I would say this will be considered a phase 4 (randomization is not part of the definition). Again semantics only.
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Post by oldfishtowner on Nov 18, 2015 6:45:04 GMT -5
Based on your third reference, I don't think this is a phase 4 study. As you say, it is different than what is described in the reference, i.e., a post-marketing surveillance study It is likely a phase 3 study because it is a randomized controlled clinical study. This is what is needed for a label change. I also agree with your comment: "Basically who would do a 100-200 million $ trial to prove a drug may be safe to the lungs if it isn't selling? The trial would have to hit the points discussed in this article and at the same time help position the drug to be a big deal." This is why I think the trial will address more than what the FDA is requiring and will be designed to show superiority. Semantics maybe but a post approval study is a phase 4. I guess if you change the patient population you are targeting (new approval) than you could be back at being a phase 3 but in this case I would say this will be considered a phase 4 (randomization is not part of the definition). Again semantics only. After a some additional reading, I agree that it may be a matter of semantics. It seems that a phase 4 study can be a randomized controlled study. And as you say, the CFR states: "Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing (phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time." (21 CFR 312.85) Other material I found describes phase 4 studies as post approval studies that look at long-term risks, which is what the pulmonary/cardio study is supposed to do. Nevertheless, the required post-marketing PD-PK studies are labeled as phase 1 studies. The difference may be that these are small, short-term studies. So it seems that all post-marketing studies don't have to be phase 4, but all phase 4 studies are post-marketing studies. Still, it's a bit confusing.
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topcard
Newbie
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Sentiment: Long
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Post by topcard on Nov 18, 2015 8:28:50 GMT -5
mss - I figure it this way (per share): Current value of TS patent = $3 5-year value of Afrezza earnings = $5 (3 million patients x $3000 x 25%)/420 million shares Speculative value of TS licensing earnings over 5 years = $5 A modest P/E of 10 Total value (in 5-years) per share = $103 Otherwise, one can always use a buy-out number that would likely be acceptable to Al - and that's probably about $60/share. Topcard, that valuation is "unusual" in my opinion. A P/E ratio is applied to earnings, now the value of the TS patent may be $3 per share or $1.25 billion, but you don't then use a P/E ratio on that, you just add the value to the value of the other items. Yes, I think $60 would be acceptable to Al, that would be about 10x what would be acceptable to me. And even Al at the height of his mental powers would likely sell for $10 tomorrow! Read it again... I didn't apply the P/E ratio to the patent value. My 'valuation' includes $10 per share in annual earnings per year, about equally split between TS licensing and Afrezza sales (at 25% royalty equivalent).
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topcard
Newbie
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Sentiment: Long
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Post by topcard on Nov 18, 2015 8:35:59 GMT -5
Topcard, that valuation is "unusual" in my opinion. A P/E ratio is applied to earnings, now the value of the TS patent may be $3 per share or $1.25 billion, but you don't then use a P/E ratio on that, you just add the value to the value of the other items. Yes, I think $60 would be acceptable to Al, that would be about 10x what would be acceptable to me. And even Al at the height of his mental powers would likely sell for $10 tomorrow! Well guys, I love fantasies about future share prices as much as the next person, so let me add some more math. IF those three segments represent actual earnings happening in Year 5, and you apply then a P/E of 10 to the $13 in earnings, I'm pretty sure you're going to get $130, not $103. If we're just going to throw 1's and 3's around, we might as well make it a share price of $301 and celebrate our future riches even more. If a little of something is good, then a whole lot more must be way better! If you're just going to dream, why not dream big? Randomly, but hyper-optimistically and perhaps just a tad sarcastically, but in a nice way, The Monger Apply the P/E to the $10 in earnings & add the $3 per share patent value... = $103. "Patents" don't have earnings unless you sell them. They do have an intrinsic value...I guestimate that for TS, it's $3 per share, or $1.2 billion... just a WAG....it's probably on the low side. Licensing the use of a patented technology generates earnings, and that's included in my 'valuation'. PS - not dreaming - just replying to the question posed by mss... what I think the actual value of the company is, ignoring what Wall Street has to say on the matter. I've done that. What's your estimate?
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Post by kball on Nov 18, 2015 8:48:38 GMT -5
Well guys, I love fantasies about future share prices as much as the next person, so let me add some more math. IF those three segments represent actual earnings happening in Year 5, and you apply then a P/E of 10 to the $13 in earnings, I'm pretty sure you're going to get $130, not $103. If we're just going to throw 1's and 3's around, we might as well make it a share price of $301 and celebrate our future riches even more. If a little of something is good, then a whole lot more must be way better! If you're just going to dream, why not dream big? Randomly, but hyper-optimistically and perhaps just a tad sarcastically, but in a nice way, The Monger Apply the P/E to the $10 in earnings & add the $3 per share patent value... = $103. "Patents" don't have earnings unless you sell them. They do have an intrinsic value...I guestimate that for TS, it's $3 per share, or $1.2 billion... just a WAG....it's probably on the low side. Licensing the use of a patented technology generates earnings, and that's included in my 'valuation'. PS - not dreaming - just replying to the question posed by mss... what I think the actual value of the company is, ignoring what Wall Street has to say on the matter. I've done that. What's your estimate? Any chance you can get a gig at Goldman?
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topcard
Newbie
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Post by topcard on Nov 18, 2015 9:40:25 GMT -5
kball... GS would never have me... I'd blow the lid off of their activities within the first few weeks, and we can't have that now, can we? ...besides - they're apparently adding plenty of MNKD to their holdings, so (for now, anyway) their actions speak louder than their words.
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Deleted
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Post by Deleted on Nov 18, 2015 22:59:48 GMT -5
Remarkable GS not only has a MannKind position but adding to it. If GS believed MannKind was going bankrupt, this would not be occurring.
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Post by monger on Nov 19, 2015 23:34:47 GMT -5
Apply the P/E to the $10 in earnings & add the $3 per share patent value... = $103. "Patents" don't have earnings unless you sell them. They do have an intrinsic value...I guestimate that for TS, it's $3 per share, or $1.2 billion... just a WAG....it's probably on the low side. Licensing the use of a patented technology generates earnings, and that's included in my 'valuation'. PS - not dreaming - just replying to the question posed by mss... what I think the actual value of the company is, ignoring what Wall Street has to say on the matter. I've done that. What's your estimate? Topcard, at this point I have absolutely, positively no clue what the actual value of the company is, but I'm pretty sure it's not $103 today. I see now where you were going with your estimate on adding the $3 patent value on the end, so I can't make fun of your math. :-) If we're talking 5 years out, and all the shorts bailing, and some actual increasing sales like a normal company, better insurance coverage like a normal product introduction after a year, and SNY announcing they're not going anywhere, and MNKD clarifying where they're going to get the money they need from, then sure, maybe that's exactly the right valuation (not SP) 5 years from now after at least a year of getting all these questions set aside. At this point I've decided that my colossal investing mistake here was in "misunderestimating" how long it would take doctors to start accepting this new treatment. I have no idea how long it's going to take to turn that situation around, but prescriptions don't appear to be gaining momentum at all, so i don't feel we're even at the starting blocks yet. That said, it's certainly possible that SNY or MNKD have all sorts of things they've been working on that they will surprise us with shortly, causing the short squeeze everyone has been waiting for. IF that happens, then once the squeeze is over, we might see the more stable share price approach something reasonable built on normal increasing sales and most worries removed, like maybe $10 in a year, and healthy growth after that out to the 5 year mark. I would be quite surprised, but satisfied, if we were able to reach $60 in 5 years. Even 50% growth in SP per year after $10 a year from now, we would only be at about $50 at the end of year 5. Sure, we could double or triple overnight, but right now if we pop 4 times we're only going to be at $10, and then we have that long climb. So yes, perhaps the real value is $103, but I doubt seriously we'll see half that in the SP at the end of 5 years. Just my gloomy two cents.
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Post by kball on Nov 19, 2015 23:56:04 GMT -5
Apply the P/E to the $10 in earnings & add the $3 per share patent value... = $103. "Patents" don't have earnings unless you sell them. They do have an intrinsic value...I guestimate that for TS, it's $3 per share, or $1.2 billion... just a WAG....it's probably on the low side. Licensing the use of a patented technology generates earnings, and that's included in my 'valuation'. PS - not dreaming - just replying to the question posed by mss... what I think the actual value of the company is, ignoring what Wall Street has to say on the matter. I've done that. What's your estimate? Topcard, at this point I have absolutely, positively no clue what the actual value of the company is, but I'm pretty sure it's not $103 today. I see now where you were going with your estimate on adding the $3 patent value on the end, so I can't make fun of your math. :-) If we're talking 5 years out, and all the shorts bailing, and some actual increasing sales like a normal company, better insurance coverage like a normal product introduction after a year, and SNY announcing they're not going anywhere, and MNKD clarifying where they're going to get the money they need from, then sure, maybe that's exactly the right valuation (not SP) 5 years from now after at least a year of getting all these questions set aside. At this point I've decided that my colossal investing mistake here was in "misunderestimating" how long it would take doctors to start accepting this new treatment. I have no idea how long it's going to take to turn that situation around, but prescriptions don't appear to be gaining momentum at all, so i don't feel we're even at the starting blocks yet. That said, it's certainly possible that SNY or MNKD have all sorts of things they've been working on that they will surprise us with shortly, causing the short squeeze everyone has been waiting for. IF that happens, then once the squeeze is over, we might see the more stable share price approach something reasonable built on normal increasing sales and most worries removed, like maybe $10 in a year, and healthy growth after that out to the 5 year mark. I would be quite surprised, but satisfied, if we were able to reach $60 in 5 years. Even 50% growth in SP per year after $10 a year from now, we would only be at about $50 at the end of year 5. Sure, we could double or triple overnight, but right now if we pop 4 times we're only going to be at $10, and then we have that long climb. So yes, perhaps the real value is $103, but I doubt seriously we'll see half that in the SP at the end of 5 years. Just my gloomy two cents. I tell people who ask how i am, i'm either going to be very wealthy or very dumb.
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Post by nylefty on Nov 20, 2015 0:19:46 GMT -5
Topcard, at this point I have absolutely, positively no clue what the actual value of the company is, but I'm pretty sure it's not $103 today. tions set aside. I tell people who ask how i am, i'm either going to be very wealthy or very dumb.
Really? Why does it have to be one or the other? If my investment only doubles in five years I won't be very wealthy, but I certainly won't feel very dumb.
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Post by monger on Nov 20, 2015 11:21:51 GMT -5
I tell people who ask how i am, i'm either going to be very wealthy or very dumb.
Really? Why does it have to be one or the other? If my investment only doubles in five years I won't be very wealthy, but I certainly won't feel very dumb. Hell, I already feel really dumb, and I'll still feel the same way even if my investment doubles in 5 years. My hindsight is amazing! I have done so many things wrong with this investment, it's absurd. However, at the time I thought I was doing the right thing because I couldn't foresee the many problems we'd run into, problems which a more seasoned biotech investor (and I'm guessing also SNY) probably saw coming. Had I bought and then gone away for 6 or 7 years, and had it up 100% at the end of that time, of course I would have missed all the drama, and I probably would have been OK with the investment, so I get your point. However, since I didn't buy and go away, I get to live with my numerous mistakes with this stock, and hopefully not repeat them.
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Deleted
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Post by Deleted on Nov 20, 2015 14:14:54 GMT -5
Eventually Afrezza will start to see reasonable growth, just not in the time frame we hoped for. However, better late than never!
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