|
|
Post by esstan2001 on Dec 11, 2015 15:45:43 GMT -5
Dudley, Sorry to nitpick, but there's a pretty big disparity between cure and treatment. Afrezza will never cure diabetes. Just wanted to make that point clear lest you mislead others. Afrezza will also not be the only treatment option needed for diabetes. The liver is constantly regulating glucose levels in the blood. A basal insulin will always be needed post-prandial to help with those spikes in glucose levels. All Afrezza does is help decrease the post-prandial glucose spike back to physiological levels. Actually, there may be some instances where early intensive insulin treatment does, in fact, result in what some would describe as a cure. A study by a group of Japanese researchers revealed that, caught early enough, several weeks of intensive insulin therapy healed the pancreas. After the EIIT was discontinued, approximately 40% of the patients required no further diabetes treatment whatsoever.
I've forwarded that study to Pascal Witz, along with a recommendation that Sanofi consider funding this group to run the study again using Afrezza. In terms of PR, Sanofi would become the opposite of Martin Shkreli in the public eye. They would be eliminating the need for basal insulin for approximately 40% of pre- and early-diabetes patients. The remaining 60% who went through EIIT would be de-sensitized to the idea of taking insulin, especially since they didn't need injections. It's similar to the brilliance of Steve Jobs of Apple Computer giving college kids steep discounts on their personal computers. The kids needed a college computer for cheap, but then after graduating they kept buying Apple McIntoshes (and eventually the I-series) for years after. The same would likely be the case with inhaled insulin.
At least that's what I advocated to Ms. Witz when I laid out the market profile. A few weeks of early intensive insulin treatment could eliminate the need even for metformin for a number of early diabetes patients. If EIIT (which must be done with an ultra-fast insulin like Afrezza) were to become the gold standard for first treatment, Sanofi would be admired for contributing to the reduction of diabetics, while at the same time catching early diabetics who don't have a remission and shepherding them to their basal/prandial insulin (ie Toujeo + Afrezza).
---
Here's the link to the study: onlinelibrary.wiley.com/doi/10.1002/dmrr.2603/full
IMO that was a brilliant tactic that warrants serious consideration; I only hope that no one in SNY management looks upon this as something that may in the long run cannibalize treatment sales. |
|
|
|
Post by stevil on Dec 11, 2015 16:14:01 GMT -5
Actually, there may be some instances where early intensive insulin treatment does, in fact, result in what some would describe as a cure. A study by a group of Japanese researchers revealed that, caught early enough, several weeks of intensive insulin therapy healed the pancreas. After the EIIT was discontinued, approximately 40% of the patients required no further diabetes treatment whatsoever.
When I hear comments like this, I can understand why doctors have such a hard time changing. What I was taught in my class is that what you're describing is called relieving beta cell exhaustion. It is already known (as I was taught this recently) that the beta cells of the pancreas become exhausted from oversecretion of insulin. The pancreas doesn't work as efficiently as it used to so it upregulates the secretion of insulin, making the beta cells work harder to produce the physiological baseline of blood glucose concentration. It would make sense if this is what you're talking about because insulin therapy would allow the remaining beta cells to "relax" and not get exhausted. But we were taught that once the beta cells become completely exhausted, they're essentially dead and without any kind of stem cell regeneration, are lost forever. I'll have to look into it, but it's funny to me that I'm already having this problem. My first flinch is that you either don't know what you're talking about or that you're mistaken in what you think know simply because it disagrees with what I believe is "fact" in my mind. But I will leave room to be humble because I have great respect for you and because this is a new kind of insulin so maybe it's producing results we haven't seen yet. I'll take a look at it when I get a little more time. Next week is a little chaotic as they're trying to cram everything in before Christmas break... |
|
|
|
Post by mssciguy on Dec 11, 2015 16:23:41 GMT -5
When I hear comments like this, I can understand why doctors have such a hard time changing. What I was taught in my class is that what you're describing is called relieving beta cell exhaustion. It is already known (as I was taught this recently) that the beta cells of the pancreas become exhausted from oversecretion of insulin. The pancreas doesn't work as efficiently as it used to so it upregulates the secretion of insulin, making the beta cells work harder to produce the physiological baseline of blood glucose concentration. It would make sense if this is what you're talking about because insulin therapy would allow the remaining beta cells to "relax" and not get exhausted. But we were taught that once the beta cells completely exhausted, they essentially died and without any kind of stem cell regeneration, are lost forever. I'll have to look into it, but it's funny to me that I'm already having this problem. My first flinch is that you either don't know what you're talking about or that you're mistaken in what you think know simply because it disagrees with what I believe is "fact" in my mind. But I will leave room to be humble because I have great respect for you and because this is a new kind of insulin so maybe it's producing results we haven't seen yet. I'll take a look at it when I get a little more time. Next week is a little chaotic as they're trying to cram everything in before Christmas break... After your finals are over stevil maybe we can talk some peptide chemistry ... a lot of which is probably not yet in standard textbooks It's such an amazing area, many "niches" to be filled, very therapeutic without all the toxicity of synthetic small molecules. Good luck with finals. |
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Dec 11, 2015 16:25:41 GMT -5
I hate when the word cure is used. If we can say anything based on user review its that Afrezza helps manage diabetes so much that it doesnt feel like they are diabetic anymore. This is just from a perspective of managing the disease as effeciently as possible Nitpick all you want. Sam Finta, Eric Fenar, Laura Kronen - many others have made statements to that effect. They have better control with less effort than they have ever experienced in their lives. They are all demonstrating HbA1c numbers that are better than my own and I am not a diabetic. Numbers they have never, ever been able to achieve no matter what treatment they used and how diligently they applied it. Al Mann has has stated repeatedly that when used in the proper regimen Afrezza can reverse and even stop the progress of Type 2 diabetes. Doesn't matter what I think or what words you hate. The truth is there is nothing out there that has ever been able to do what Afrezza can do. Paradigm shifts take time to develop but once they do they are unstoppable. What you said is not a cure. It is exactly what Afrezza does and why it is a game changer. A cure would be - Someone takes a hit from a dreamboat and your pancreas starts working again and you no longer need put insulin into your body. I think many dont understand HOW MUCH MANAGING DIABETES SUCKS and how much easier Afrezza makes their life. |
|
|
|
Post by stevil on Dec 11, 2015 16:26:52 GMT -5
What you're describing is "treatment". A cure would be the complete regeneration of a healthy pancreas. I have to check out the info that mnholdem sent me, but so far, we have never witnessed that happening. There has been some beta cell regeneration with GLP-1 but not with insulin. The only effect we've seen from insulin is the relief of beta cell exhaustion. The reason this is not a cure, is that beta cells do not get regenerated with insulin. So while less insulin may be needed (or none at all in some instances) it is not proof of a cure. A lot of type 2s can be "cured" by a simple change to diet and exercise. That's actually the recommended therapy right now. But Americans don't want to be told that, so we prescribe them pills so they don't have to change their lifestyle. The reason I had "cured" in quotations is because the manifestation of the disease will go away. Meaning, if a type 2 eats better food and exercises, their HbA1c will drop below pre-diabetic levels naturally. But if they ever change their habits again, the disease will reappear because they now have fewer beta cells than a healthy pancreas and they will get exhausted quickly again. There may even come a point where doing all the right things will still lead to disease because there just aren't enough beta cells left to secrete the amount of insulin needed to lower the blood glucose concentration. The pancreas doesn't truly get better, it just doesn't get any worse. What you are describing from Sam, Eric, and Laura is not a cure. They still need insulin. Again, barring the results of the test mnholdem sent me, they will need insulin the rest of their lives. That's not a cure. It's a treatment. And that's a HUGE difference and would immediately combust the label. |
|
|
|
Post by dreamboatcruise on Dec 11, 2015 16:30:30 GMT -5
Trend, the notion that my statements could have any effect on MNKD's price seems absurd. What I know about Al Mann's finances is from the public disclosures. The point I make is simple. Even if we know nothing about Al's financial position, how can some say that Al will be able to fund the company or take it private? And if you do know something more, what can you say beyond "I have made no statements..."? Enough said on this topic. Al will do what Al wants to do. His net worth is reported to be $1.5-2.5 billion. If the reported numbers are true, Al has the financial wherewithal to. take the company private, or lend or arrange loans for Mannkind. As for you and your comments, they will be viewed by myself and others in the context you admitted to - hoping for lower prices. Trend According to Forbes his net worth was $1.5B on Feb 13, 2015. That was when MNKD had a market cap of $2.86B. Now MNKD has a market cap of $0.63B. Based on Al's share of MNKD and the drop in value, he likely is no longer a billionaire (today). This estimate is supported by the fact that the Forbes site where the list is maintained has a "real time" list as well which reflects current stock values, etc. Al Mann is not on this "real time" list of billionaires. That probably isn't terribly useful info as it doesn't give much of an indication of whether he could or would put more into MNKD. He's not in the poor house, but not as rich as he used to be. |
|
|
|
Post by mssciguy on Dec 11, 2015 16:40:38 GMT -5
Enough said on this topic. Al will do what Al wants to do. His net worth is reported to be $1.5-2.5 billion. If the reported numbers are true, Al has the financial wherewithal to. take the company private, or lend or arrange loans for Mannkind. As for you and your comments, they will be viewed by myself and others in the context you admitted to - hoping for lower prices. Trend According to Forbes his net worth was $1.5B on Feb 13, 2015. That was when MNKD had a market cap of $2.86B. Now MNKD has a market cap of $0.63B. Based on Al's share of MNKD and the drop in value, he likely is no longer a billionaire (today). This estimate is supported by the fact that the Forbes site where the list is maintained has a "real time" list as well which reflects current stock values, etc. Al Mann is not on this "real time" list of billionaires. That probably isn't terribly useful info as it doesn't give much of an indication of whether he could or would put more into MNKD. He's not in the poor house, but not as rich as he used to be. But, his kids are all taken care of for life (for better or for worse) and he has multiple legacies with universities, institutes, and here... I love the Mann's honesty and consider him a role model. We need to see Sanofi press the GO button. We know that they need the money and Afrezza is the best thing they got... it's a monopoly, and like Peter Thiel says, you don't want to be spending your time on anything but a monopoly. Paging Dr. Brandicourt, read Peter Thiel s'il vous plait. Tens of millions of people globally can be helped with Afrezza now, years of added life, and quality of life to boot. What more do you want? |
|
|
|
Post by spiro on Dec 11, 2015 16:47:34 GMT -5
Hmmm, the last time Spiro talked to his pancreas, it told him that it was making a lot more insulin than it was 6 month's ago. Not cured yet, but certainly relieved by that phase one digestion help.
Spiro here, BG 82, four hours after lunch. Spire's good friend Blindhog, tell him that his pancreas is also shouting some great numbers out.
|
|
|
|
Post by mnholdem on Dec 11, 2015 17:01:40 GMT -5
When I hear comments like this, I can understand why doctors have such a hard time changing. What I was taught in my class is that what you're describing is called relieving beta cell exhaustion. It is already known (as I was taught this recently) that the beta cells of the pancreas become exhausted from oversecretion of insulin. The pancreas doesn't work as efficiently as it used to so it upregulates the secretion of insulin, making the beta cells work harder to produce the physiological baseline of blood glucose concentration. It would make sense if this is what you're talking about because insulin therapy would allow the remaining beta cells to "relax" and not get exhausted. But we were taught that once the beta cells completely exhausted, they essentially died and without any kind of stem cell regeneration, are lost forever. I'll have to look into it, but it's funny to me that I'm already having this problem. My first flinch is that you either don't know what you're talking about or that you're mistaken in what you think know simply because it disagrees with what I believe is "fact" in my mind. But I will leave room to be humble because I have great respect for you and because this is a new kind of insulin so maybe it's producing results we haven't seen yet. I'll take a look at it when I get a little more time. Next week is a little chaotic as they're trying to cram everything in before Christmas break... After your finals are over stevil maybe we can talk some peptide chemistry ... a lot of which is probably not yet in standard textbooks It's such an amazing area, many "niches" to be filled, very therapeutic without all the toxicity of synthetic small molecules. Much of medicine is an Undiscovered Country. It will be difficult for companies like MannKind to blaze new trails. After you've read the study, perhaps you'll understand why Al Mann gets so excited whenever he talks about Afrezza. He also is on public record as having used the word "remission" in describing the EIIT and also (Sanofi probably hates this) that Afrezza should be prescribed before basal. I'll see if I can find that old interview. In the meantime...
Study hard, stevil. Make us proud, buddy.
|
|
|
|
Post by dreamboatcruise on Dec 11, 2015 17:08:40 GMT -5
Hmmm, the last time Spiro talked to his pancreas, it told him that it was making a lot more insulin than it was 6 month's ago. Not cured yet, but certainly relieved by that phase one digestion help. Spiro here, BG 82, four hours after lunch. Spire's good friend Blindhog, tell him that his pancreas is also shouting some great numbers out. Apologies if you've posted it elsewhere recently, but what's your most recent A1c... and when are you likely to get an update? Unlike share price, falling A1c is a great thing. |
|
|
|
Post by kball on Dec 11, 2015 17:18:45 GMT -5
After your finals are over stevil maybe we can talk some peptide chemistry ... a lot of which is probably not yet in standard textbooks It's such an amazing area, many "niches" to be filled, very therapeutic without all the toxicity of synthetic small molecules. Much of medicine is an Undiscovered Country. It will be difficult for companies like MannKind to blaze new trails. After you've read the study, perhaps you'll understand why Al Mann gets so excited whenever he talks about Afrezza. He also is on public record as having used the word "remission" in describing the EIIT and also (Sanofi probably hates this) that Afrezza should be prescribed before basal. I'll see if I can find that old interview. In the meantime...
Study hard, stevil . Make us proud, buddy.
Yeah Stevil, and hurry up and start prescribing already. |
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Dec 11, 2015 17:32:36 GMT -5
It has been spent. $10M/month cash burn; 2 additional fill/finish lines at $13M/each; repayment of Bank of America loan used some of the funds. For accounting purposes the milestone payments could not be "booked as revenue" until Afrezza and the Sanofi JV become profitable, because of the offsetting liability of the JV expenses covered by the Sanofi $175M line of credit. But the cash was in their bank account and that cash on hand is dwindling too fast. Afrezza is everything Al Mann claimed and more. It may become a true blockbuster in 5 years. MNKD will probably not survive to see that day. When Al began this journey 20 years ago it may have seemed like he had sufficient capital. Today it is clear he and his fellow investors do not have the needed staying power. And remember that although Al is/was a billionaire, much of that money is already tied up in MNKD and is not a pile of assets that can help MNKD. When Afrezza went to market in February anything was possible. Now we know that afrezza is proving its effectiveness every day, but acceptance by the medical establishment will apparently take too long for MNKD to survive.The above assessment is too pessimistic. First, even if Mannkind has to do a second offering at $1 per share (which I think is not needed and very unlikely). If they sell 100 million shares at that price, they will raise $100 million. And 100 million shares is less than 25% dilution. Add $100 million to the existing financing in place, that will be enough to support Mannkind to second half of 2017. With the healthy growth of refills we are currently seeing, Afrezza will sell at least 10 million a quarter a year from now, and more than that by the second half of 2017. And if necessary, Mannkind can always choose to suspend the other TS application studies temporarily, that will save them a few millions a quarter. That is to say, if nothing else happens, by second half of 2017, Mannkind will be much closer to break even. Wouldn't that enable Mannkind to raise additional funds at that time? I would think so. And as you said it " now we know that afrezza is proving its effectiveness every day", won't there be some BPs interested in getting involved, if Sanofi is not actively promoting it? I got to believe there are interested parties there. And as we have seen in the Al Mann gala video, Al has friends at many BPs, e.g., Medtronics and Dexcom. If he really needs it, he will be able to seek some financial support from some of his friends, especially if you consider Al's track record and the fact that "now we know that afrezza is proving its effectiveness every day". I think at this point, Al is still seeking to get funds from the open market, as we have seen with the TASE move. But if he can not get sufficient funds from the open market, a TS partnership, or a Sanofi milestone or other support, he will still be able to pull some financial support from his friends. I'd like to share a conversation I remember having about 17 yrs ago. Bell labs was bought by AT&T which eventually was spun off to become lucent. A friend of mine was new to investing and was very, very excited. lucent was on a tear as were most networking companies at the time in the big rush to get ready for Y2K (wow, remember that? people were stockpiling supplies for the pending end of world Y2K event lol) and companies like lucent were rising and splitting shares like crazy. He explained that 7 more splits and he'd be a millionaire. I tried to explain to him that in another 7 splits Lucent would have over a trillion shares out, which wasn't likely, and that the amount of buying to get lucent there would be unprecedented in the history of the stock market. He dismissed my conversation and told me I was too old to understand the new economy. lol....if you're familiar with the lucent story you know what happened next. So, I say with all due respect and awareness that this is yet another negative statement from me. But, why stop now  Here goes - MNKD can't sell 100 million shares in today's environment. Who's going to buy the shares? The israeli's didn't want shares and that was offered at a discount and the shares bought was forced fed. In august mnkd had to lay out cash because investors wouldn't take the shares as offered. So to state matter-of-factly that mnkd can just sell 100 million shares...not seeing it. |
|
|
|
Post by spiro on Dec 11, 2015 18:02:22 GMT -5
dreasmboatcruise.,
Started 7.1, then 6.1 and 6.3, next test mid January. Still take 4 units at meals, with correction dose of 4 units, if needed after overindulging or heavy snacking. A glass of eggnog with cookies is brutal. Seasonal snacking this year has been sorta out of control, but hopefully the next A1c will still be OK.
Spiro
|
|
|
|
Post by dreamboatcruise on Dec 11, 2015 18:07:55 GMT -5
@davinci... I too would put a big question mark on a large share offering right now and what valuation they could get. While it isn't an exact comparison, just imagine if the shorts have borrowed and stockpiled another 100 million shares and unleashed it on the market right now... what would that likely do to the price? Significant buying just seems hard to come by, that's why we're having a hard time finding a floor.
|
|
|
|
Post by compound26 on Dec 11, 2015 18:25:40 GMT -5
@davinci ... I too would put a big question mark on a large share offering right now and what valuation they could get. While it isn't an exact comparison, just imagine if the shorts have borrowed and stockpiled another 100 million shares and unleashed it on the market right now... what would that likely do to the price? Significant buying just seems hard to come by, that's why we're having a hard time finding a floor. Certainly not a second offering on a date when the Dow was down 300 points. The 100 million shares at $1 was just an illustration. There should be some opportunity time (like the announcement of TS deal or something like that) in the coming months to offer some shares. Recall the debale we had in early November when the TASE shares were bought, PPS went from 1.76 to 3 (at some point) in one day. And Mannkind certainly does not need to offer 100 million shares at a single offering. With Al Mann on board, Mannkind will have some flexibility in waiting for an opportunistic time to raise needed funds. |
|
Here goes - MNKD can't sell 100 million shares in today's environment. Who's going to buy the shares? The israeli's didn't want shares and that was offered at a discount and the shares bought was forced fed. In august mnkd had to lay out cash because investors wouldn't take the shares as offered. So to state matter-of-factly that mnkd can just sell 100 million shares...not seeing it.