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Post by dreamboatcruise on Jun 3, 2018 14:58:59 GMT -5
DBC - Lets see what happens. Once GWPH gets their product approved RLS just needs to show non-inferiority with an already approved inhalation device. The RLS trials could go pretty quick. Well, dronabinol is already approved which is the API being targeted first (per MNKD presentation). Might that lead to some faster approval with less trials? Treprostinil seems to be the same situation. It is shortened process but still 3 years from the start of the first clinical trial. I guess unless there is some argument that technosphere dronabinol would be different, I'd use TrepT as a reference for expectation.
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Post by dreamboatcruise on Jun 3, 2018 14:48:12 GMT -5
Actually he seems to have been generous with his assessment. The median income is actually considerably lower than the average since there is growing professional class making near first world salaries that raises the average. The median is $616 per year (source: quick google). So would you really think it twisting anything to say that at least half the population wouldn't be able to afford Afrezza? In fact a quick read of en.wikipedia.org/wiki/Healthcare_in_India turns up a figure that 63% lack access to needed medications. Bottom line, however, is captured by the fact that US pharma market is over 10x what India's is despite India having much larger population. One would expect MNKDs revenue potential in India compared to its potential in US to roughly be the same ratio as the overall pharma markets in the two countries. Or maybe even more relevant would be to look at revenue for Novolog in India vs US if those figures are available. It's simply a matter of scale......look at it this way, I can place a Mercedes dealership in a city of 10,000 or a city of 1,000,000. If only the top 1% of the population can afford to buy one of my cars, where am I better to place it? It makes no difference what the "median" income is, the top 1% total number is far more in the city of 1,000,000......... Well, a Mercedes dealership in most US cities with 100,000 would undoubtedly be better than most Indian cities with 1,000,000. A city of 10,000 probably wouldn't support a Mercedes dealership anywhere unless it's short drive to larger population base. But not really sure what point we're driving towards. I think one could dig up prandial insulin sales figures for India if one really wanted to estimate what revenue could look like for Afrezza. Undoubtedly there is potential to make money, just not nearly as much as in US.
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Post by dreamboatcruise on Jun 3, 2018 14:13:50 GMT -5
That's a tough one. I tried to help a woman for her Type1 daughter about a month ago at a JDRF 2018 TypeOneNation Summit by steering her to an Endo, however, he is an Adult-only Endo. Children should see Pediatric Endos. That Adult Endo would not prescribe to children because he said that he could potentially get in a lot of trouble if any problems resulted (because Afrezza is not labelled for children). The Mannkind rep was there and he could not help. I believe they are not allowed to refer patients to doctors. Certainly if the purpose of a referral was to send someone to a doctor known to be receptive to off-label that would be something any pharma should steer well clear of.
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Post by dreamboatcruise on Jun 3, 2018 13:04:24 GMT -5
If Afrezza came first would anybody be using a pen? In my opinion the pen will become obsolete because with Afrezza there are less steps... more convenience, no pain, ( some insulin’s really sting ) no scar tissue to contend with. It works faster. You don’t have to plan out your meals. You can keep it in your car, or wherever you want for emergency corrections because it lasts for months or years without refrigeration. And it has a cool factor! Especially with the kids:-) 10 years from now people just may think pens were barbaric... if afrezza came first would anyone tolerate the hyperglycemia, hypoglycemia of subq rapid acting insulin? www.screencast.com/t/NJow1xn5RzPMthe poor blood glucose control of subq rapid acting insulin is the primitive part. If Afrezza had come before Exubera, much less before RAAs, things would likely be very different.
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Post by dreamboatcruise on Jun 3, 2018 12:50:11 GMT -5
Why must people twist the numbers to fit their own agenda? India's population is about 1.3 billion people! If only 10% could afford Afrezza, that is 130 million, even just 1% is 13 million...............to me that is a lot of people......... Actually he seems to have been generous with his assessment. The median income is actually considerably lower than the average since there is growing professional class making near first world salaries that raises the average. The median is $616 per year (source: quick google). So would you really think it twisting anything to say that at least half the population wouldn't be able to afford Afrezza? In fact a quick read of en.wikipedia.org/wiki/Healthcare_in_India turns up a figure that 63% lack access to needed medications. Bottom line, however, is captured by the fact that US pharma market is over 10x what India's is despite India having much larger population. One would expect MNKDs revenue potential in India compared to its potential in US to roughly be the same ratio as the overall pharma markets in the two countries. Or maybe even more relevant would be to look at revenue for Novolog in India vs US if those figures are available.
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Post by dreamboatcruise on Jun 3, 2018 11:02:24 GMT -5
The big question is when are they going to have a product to sell? If they are going for an FDA approved drug it would be years away still.
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Post by dreamboatcruise on Jun 3, 2018 10:57:42 GMT -5
George - the one big Technosphere product in the pipeline is TS-CBD. It may actually be the RLS efforts which put Technosphere on the map. Lots of doctors would have no issue prescribing an FDA approved CBD product while the same doctors view insulin as barbaric. RLS is definitely an interesting one. Very quiet for a long time. However, any positive move on that front has the ability to add rocket fuel to the current Afrezza and TrepT storyline. Given that they haven't registered any clinical trials, they are still years away from revenue.
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Post by dreamboatcruise on Jun 3, 2018 9:40:59 GMT -5
While that may happen for some patients, I think that is not at all the norm to have such severe injection site reactions. For many patients, and especially doctors old enough to remember older treatment options, they would likely view today's ultra long acting basals and RAAs delivered with very fine needle pens as being amazing advancements rather than barbaric. And I would just speculate that the doctors that currently are resistant to prescribing Afrezza are unlikely to be swayed to do so by someone calling their current medical practices "barbaric". Could be wrong, what do I know about psychology... maybe calling people barbaric is persuasive? I'm just thinking I wouldn't like it if I were an endo. To me, perhaps I'm over simplifying, I think a strong marketing message is that Afrezza allows one to tailor their insulin around what they eat rather than either forcing one's diet to conform to the insulin or settling with damaging and risky glucose variability. I think current injected insulins can be perfectly good solutions for those willing to learn and adjust to the needs of the insulin... which many/most don't achieve. Well that makes sense as long as only a few have horrible injection site reactions and the needles are smaller. NOT!Of PWD I know on insulin, I don't know any with the type of reaction described where one could see scarring of someone at the beach. But quite frankly, I'm not even sure I know what you were trying to convey with the beach story. What you are saying doesn't make sense? The needles indeed are much smaller than were used a couple of decades ago with syringes... and "horrible" injection site reactions are indeed quite rare. And just because a few people have reactions to something doesn't to me mean it is barbaric... peanuts aren't barbaric because some nearly die when they eat them.
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Post by dreamboatcruise on Jun 3, 2018 1:15:16 GMT -5
When it comes to technosphere one has to look at where it really is competitive.
1) Some drugs would have no benefit from being delivered to lungs... they aren't to treat a lung disease and speed isn't an issue (think of how many drugs are formulated for "extended release").
2) That leaves three classes for consideration... drugs targeting lungs, drugs that would benefit from speed and drugs that otherwise require injection.
3) With modern injection technology the latter isn't a slam dunk... as we've learned from Afrezza.
4) If the API can be formulated as an inhalable using technology other than technosphere (such as traditional dry powder formulation) then the value MNKD could extract is significantly reduced.
5) MNKD does not yet have a metered version of the inhaler as is available in some of the alternative technologies.
6) Technosphere does have stabilizing properties for larger peptide based APIs not present in the alternatives.
What is Technosphere worth based on all of that ? ? ?
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Post by dreamboatcruise on Jun 3, 2018 0:50:30 GMT -5
You must truly believe in something to commit fully to it. Most are easily involved, but few committed to an outcome. Al Mann was the type of person who committed to doing something. The same is true of Kent K. So far, Mike C. fits the bill as well. If he succeeds, MNKD will not be sold, but rather be acquiring assets. MNKD will become a member of the BP club. Mike will be a billionaire. I hope Mike sees this reality unfolding. I do, and it is why I stick around. Al certainly qualified for being fully committed as he put a significant portion of his own wealth into MNKD. But even within the startup world there is significant sliding scale. One can more easily give up "opportunity cost" as Mike has done, but that isn't like risking one's own capital. Not saying Mike's not committed, but having been in both situations, I can say risking one's own capital, and at times working without pay, is an entirely different level of "fully committed".
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Post by dreamboatcruise on Jun 3, 2018 0:35:56 GMT -5
If you look at the first definition of barbaric (found by googling "barbaric"), which is the one I think the vast majority of users intend when they say barbaric it, you would get: savagely cruel; exceedingly brutal. Damn if that does not describe my thoughts when I saw this kid on the beach and thought to my self, if he aint lucky to be alive after taking a gut full of buck shot only to learn that's the way you treat diabetes. Barbaric maybe not at the time but sure as hell looked that way. But now given a better alternative I cant think of a better way to describe it. While that may happen for some patients, I think that is not at all the norm to have such severe injection site reactions. For many patients, and especially doctors old enough to remember older treatment options, they would likely view today's ultra long acting basals and RAAs delivered with very fine needle pens as being amazing advancements rather than barbaric. And I would just speculate that the doctors that currently are resistant to prescribing Afrezza are unlikely to be swayed to do so by someone calling their current medical practices "barbaric". Could be wrong, what do I know about psychology... maybe calling people barbaric is persuasive? I'm just thinking I wouldn't like it if I were an endo. To me, perhaps I'm over simplifying, I think a strong marketing message is that Afrezza allows one to tailor their insulin around what they eat rather than either forcing one's diet to conform to the insulin or settling with damaging and risky glucose variability. I think current injected insulins can be perfectly good solutions for those willing to learn and adjust to the needs of the insulin... which many/most don't achieve.
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Post by dreamboatcruise on Jun 3, 2018 0:21:55 GMT -5
The idea that MNKD is a one trick pony: the thought that Afrezza will be our only (potential) success. Cant help but wonder about all the various applications of Technosphere that wanted to be pursued, but due to lack of resources had to be shelved for another time. Mannkind was formed in 1991, correct? So we could potential have 25+ years of research/ideas that still need funding. So when and if the money starts to (hopefully) roll in, do thesw ideas get a second glance. For example, MNKD previously was into oncology, right? Does this have a chance to be "born again".For those of you who have read some of my previous posts, I often liken MNKD to OLED. Shorted to hell, left for dead, stumbles back to life, bad mouthed by devil-like hedges, shorted again, left for dead again, you get the picture. (Picture Boris from the movie Snatched). But all the while OLED did something wonderful, patent everything and anything related to organic led. So far as to win validation over OLED heavy weight Idemitu-Kosan in Japan regarding patents. MNKD has been continuing down the same path. With every so often a patent here a pantent there, so when the time comes and cash is (again hopefully) plentiful we can revisit these ideas and further are marketshare for Technosphere and other potential applications that were onve invisioned but due to lack of funds abandoned. No, they divested oncology IP and don't have any of the people now. Technosphere is the pipeline now, and basically just as new delivery route for existing APIs. I had high hopes, but then when a firm was hired specifically to find licensing opportunities and nothing came of it, I began to question. Hopefully there are at least a couple where unique properties of pulmonary delivery actually is a compelling story... and where there aren't other well established pulmonary delivery methods that work equally well to technosphere.
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Post by dreamboatcruise on Jun 2, 2018 16:50:35 GMT -5
I guess in marketing as in politics, going negative connects with some and turns some off.
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Post by dreamboatcruise on Jun 2, 2018 2:33:07 GMT -5
The sad fact of dilution. It may well be unrealistic to ever reach levels that would make all investors whole. I acquired quite a lot of options a year ago and brought my break even point down significantly. At this point I'd be thrilled with $10 and have a nice, if not huge profit. I do think ultimately there is potential to hit $12 to $16, perhaps higher if future dilution is at low end of range I think possible. Dbc, i read a lot of your post over the years and i have often thought you were very negative about mnkd. Unfortunatly, it turn out you were often right. I would like to know what do you think is the potential mc in 3 years for mnkd if afrezza became successful enough to keep the lights on and the growth in script continu. The potential is huge in long terme no? 12-16$ or 2-2,5b mc seems low for a product AND a delivery system that can change the world dont you think? Being conservative I think we'll have 250 million shares outstanding before profitability. $12-$16/sh is then $3-$4B mc. That is assuming Afrezza is successful but doesn't "change the world". Resistance to Afrezza is much greater than I would have assumed years ago. I now assume that will not disappear quickly. The landscape has changed for drugs, and MNKD has a big uphill struggle. I think they will prevail, but it will be slow and I think there will be pressures on pricing that din't exist 5 years ago.
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Post by dreamboatcruise on Jun 2, 2018 2:24:34 GMT -5
The sad fact of dilution. It may well be unrealistic to ever reach levels that would make all investors whole. I acquired quite a lot of options a year ago and brought my break even point down significantly. At this point I'd be thrilled with $10 and have a nice, if not huge profit. I do think ultimately there is potential to hit $12 to $16, perhaps higher if future dilution is at low end of range I think possible. The eternal optimistic in me ponders that as Dr. Kendall thinks Afrezza is the new "gold standard" and current treatments are "barbaric". I would argue that we still have a lot of market to penetrate, not just in the US, but the world. Thus $12-$16 a share even with massive dilution, is underestimating its potential. We are patent protected for years to come. I would relate Afrezza to the first iPods. No competion no one even came close to Apple for years. That will be us. Imagine Apple without Android phones to compete with. While our market is constrained to those with diabetes, that market grows yearly, sadly. So, I conclude by saying, stay long. We never know when our time will come. The "barbaric" statement to me lowers my expectations for him. It seems hyperbole that a scientist should not be using. But I realize many love that non-scientific hyperbole. I'm not sure he ever said "gold standard". Hope you are right about Mannkind financial potential. Certainly many have been predicting awesome returns for many years. I certainly do plan on holding, at least until I'm back to even... which for me is in the $8 range.
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