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Post by stevil on Jan 8, 2016 16:57:42 GMT -5
This is all well and good, but why don't people spend their efforts researching companies like MNKD that went bankrupt to draw parallels? Y'all wonder why you were blind to what happened yet you only allow yourself to see half the story... Open both eyes, then make your judgement... Mannkind hasn't declared BK though. Odds aren't good the company survives but let's not make a claim that hasn't happened yet. I'm not making a claim about what has happened yet. The point of this thread was to use history to find similar companies whose stories ended up being successful. This board often times lacks balance. Very few drugs get developed with the intention of being a middle-of-the-road product. With the cost of R&D and marketing, only the best of the best ideas get pulled from to get brought to market. Every drug that gets developed was probably thought to be a blockbuster in its own right. For the record- I'm still on the Afrezza train. I still think it's an amazing product and I hope I'm wrong. But with social media and the internet, nothing extraordinary stays a secret anymore. At some point you just have to accept that maybe there isn't enough interest in Afrezza to thrive. The odds were already stacked against us when we were with SNY, and despite the spin the eternal optimists keep trying to use to say we're better off now, it's never a good thing when you get dropped by a company that specializes in the very business your product was tailored for. I'm not buying that SNY was afraid it'd cut into the market share of their other medications. The only way for it to do that would be for Afrezza to reach blockbuster status. Then, guess what? They have a new blockbuster on their hands. The only logical reason SNY decided to drop Afrezza was because they didn't think it would be a profitable addition to their portfolio. If they really saw such disruptive potential behind it, they wouldn't let it fall into the hands of their competitors... because, guess what? There goes all that market share again and this time they're not recouping any of it. Instead, they're losing all of it. I'm not saying that SNY did all they could to make sure Afrezza was a success, but I'm not saying they didn't, either. Gallop polls don't form their statistics after polling every single person in the US. They take a small sample size and extrapolate their data to make their generalizations. And they've done a pretty decent job if you do a study on them. Statistics are freakishly accurate when used well. Trend lines are accurate an overwhelming majority of the time. So why am I saying all of this? Because maybe instead of rolling out and spending $100 million to market this new drug, they took their time and were a little more strategic about it. I'm sure SNY knows who the right Docs were to contact in regards to being a little looser in their prescribing habits. They probably targeted them first. Then, it's not difficult to make inferences based off of feedback from them. The truth is, there are so many different variables that go into why Afrezza will succeed or fail. Insurance price, doctors willingness to prescribe, patient willingness to change a potentially lifelong brand that they're comfortable with and understand, etc. We need to remember that Afrezza didn't reinvent the wheel. There hasn't really been a dire need for a new insulin medication. The stuff we have now, while inferior, still produces decent results. If you own something that does what it's supposed to and gives you the results you expect, do you listen to people that try to sell you on "the next best thing?" I usually blow those people off. I'm not saying it's impossible. I'm saying it's even more improbable than before that Afrezza becomes what we all hope for it to become. By all means, do your research. Just make sure that you're being fair to yourself by looking for the rule and not the exception. An analogy I would draw for the feeling I get after reading some posters on this board is that they would sell their house to buy every powerball ticket they could afford and then be devastated when they didn't win. In reality, they didn't realize that what they were dumping their money into wasn't really that wise of an investment in the first place. It still makes me sad the people that put more money into this stock with the expectation that it will return appreciably. Any investment should be met with extreme caution and speculative at best. What sign, thus far, has Afrezza shown that it can be successful?
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Post by stevil on Jan 8, 2016 16:29:20 GMT -5
This is all well and good, but why don't people spend their efforts researching companies like MNKD that went bankrupt to draw parallels? Y'all wonder why you were blind to what happened yet you only allow yourself to see half the story...
Open both eyes, then make your judgement...
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Post by stevil on Jan 8, 2016 13:35:51 GMT -5
It's highly unlikely that insulin will ever be available over the counter for a couple reasons (probably amongst many others):
The insulin/glucagon pathway affects so many metabolic processes- much different than taking a pain reliever for pain or cold medicine for cough. While they still affect other metabolic pathways, the impact they could have is much, much smaller.
The dosing needs to be controlled and monitored. PWD usually change their dosage over time, and it's ill-advised to do that independent of a physician.
As is pertains to Afrezza, while insulin has been on the market for over 100 years, you'll never see a branded drug go OTC before a generic is available not only from a pricing perspective (so much more money to be made behind the counter. Again, in regards to Afrezza, PWD are insulin-dependent. There is no benefit to lowering price that low when demand is 100% in your favor) but also because it takes years of showing safety and efficacy before the FDA will allow the general public to play doctor on their own. There has to be significant data to suggest that the medication is safe. This won't happen for many, many years for a new drug as the data takes a long time to get collected and charted.
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Post by stevil on Jan 7, 2016 11:07:04 GMT -5
Good points but how did Al & his team not work through the process & see the conflict of interest with SNY? Unless SNY was the only one to step up to the plate then I could see Al giving in to get Afrezza on the market. I just don't know what to think anymore! Great product, FDA approved, global possibilities, better health for patients... yet we are worried about surviving until 2017. Hopefully this doesn't hijack the thread, but this comment lends proof for why it's important to have differing opinions on a message board. This isn't intended to be an "I told you so" kind of post, but for the life of me, I can't understand why some on here have difficulty reading that all wasn't right in the Afrezza world. It's always good to surround yourself with people who have a different angle on things to help you see the complete picture. The blind faith in Al Mann, while understandable, should not have been so easily granted. Everyone makes mistakes.
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Post by stevil on Jan 7, 2016 11:03:34 GMT -5
I don't understand this line of reasoning. First, Lantus is going generic, so any profits from it were going to be severely depleted anyway. Second, SNY could have dominated the market with both prandial and basal insulin instead of maybe owning it with basal. I haven't had time to follow the numbers, but I thought I remembered seeing that Toujeo, thus far, has been unremarkable. So, "going against its golden goose franchise" isn't really a logical argument. Any lost sales in basal (from eventually needing less of it in type 2s) would be realized with Afrezza, at least initially, unless and until the patient no longer needed insulin for control. Perhaps that is why they set the price so high, though. If they couldn't get the high asking price, maybe it wouldn't have made sense from a numbers standpoint. In any case, it still seems counter-intuitive to me. It would seem the more options people have, the better. Especially when that one option is far different than any other out there...
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Post by stevil on Dec 28, 2015 14:12:06 GMT -5
Your confusion lies in your understanding of remission. Remission is the alleviation of symptoms while still being susceptible to the disease. I've tried to simplify the science the best I can. I don't have all the answers, but I have to trust that my education is correct. I have been taught both by peer reviewed journals and PhD professors who have done extensive research in their field.
You, or anyone else, may disagree with the current literature and accepted scientific fact- Lord knows scientists have been wrong before. But I feel like I have a very good grasp of what I've been taught and "cure" should not be used.
If you've known anyone who has been diagnosed with cancer, remission should be an easy concept to understand. The cancer is considered to be in remission for 5 years after no detectable cells are found in the blood. But they don't use cure until those 5 years because the individual is at a higher risk of getting cancer because only one cancer cell needs to survive to manifest the disease again. It sometimes takes years for pathologies to present- as they need time to grow and multiply.
that might be a poor example because it's not the same kind of idea with diabetes. Cancer is the lack of harmful cells while diabetes is the lack of beta cells. And unlike cancer cells, beta cells do not replenish themselves. That is why it's considered remission. It appears to be a cure because the symptoms alleviate, but the individual is still susceptible to getting the disease because their body isn't properly healthy. In other words, if they were to keep the same diet/exercise that lead to the disease, they likely would be insulin dependent the rest of their lives in short order, whereas a healthy person could continue to eat what they want without manifesting the disease.
Im sorry if this still doesn't make sense. If it doesn't, I'd encourage you to keep studying and find someone who can explain it in a way that will make sense to you. But I feel I have a very strong grasp of the latest information and there is a very broad distinction between cure and remission/treatment and thus should not be used when describing Afrezza or any other insulin product.
Ill answer any direct questions that I haven't already addressed if I can help clear anything up, but I hope you'll forgive me for bowing out from future discussion on this matter.
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Post by stevil on Dec 27, 2015 18:39:31 GMT -5
I think it's important for people to know what they're investing in... So for those who think I'm here to soft bash- I'm not... But it's important to get facts straight. sciencelife.uchospitals.edu/2014/10/13/for-patients-with-type-2-diabetes-remission-is-rare-but-not-impossible/if you read here, you'll see that diet/exercise has been deemed the best treatment for type 2 diabetes. Diet/exercise has also shown to cause remission. Bariatric surgery has actually been called a cure by some because it reduces the amount of insulin needed to keep glucose levels at appropriate levels. But even that should not be considered a cure as it does nothing for the pancreas other than relieving the amount of work needed to keep glucose low. Im not saying that early insulin therapy isnt beneficial. For many people, lifestyle changes may not be realistic. It may even prove to be better for all to relieve beta exhaustion. But remission and cure are not the same. Ill explain the difference. Type 2 is largely genetic. Let's say the average person is born with 100 beta cells (for simplicity). A type 2 is born with 75 beta cells. 50 beta cells are needed to show disease. Over time, they lose the function of some of their beta cells. Let's say they have 65 left that are trying to do the job of 100. They get overworked. In essence, they get inflamed. So even though some beta cells are lost, there are still enough to function properly, but even the ones that are left are overworked so they aren't working efficiently. So those 65 act like 50 because they get tired. So if you start insulin, you allow those cells to relax and get back up to 100% of 65 but they don't gain back the 10 they've lost over the years. Thats what the remission is. Remission is when a disease is still present but isn't actively presenting. So type 2s still have the disease but they're healthy enough to not have symptoms. Again, this is not a cure. It's just beta relaxation, which is what the study was talking about. As far as I know, only peptides have shown beta cell mass increases. Afrezza is an amazing drug, but it won't cure diabetes. It is, however, the best drug we currently have for diabetes.
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Post by stevil on Dec 27, 2015 2:54:50 GMT -5
Finally got some time in the late hours to check out your study. I couldn't find any information that I would deem "new". I posted earlier in this thread that beta cell deterioration would stop and that insulin therapy for type 2's could potentially lead to what would appear to be "remission", while the individual would still have decreased beta function, and thus, be at a higher risk later on of acquiring diabetes if they return to their old habits of diet/exercise, or their beta function decreases even after their habit change.
I'll be honest, it's late, and I didn't scour every word. But I felt like I skimmed the gist of it with the attached quote:
There is general agreement that mitigating the long-term glycaemic exposure in type 2 diabetes would be achieved by selecting a treatment that can preserve beta-cell function [17-19]. This is critical because progressive deterioration in beta-cell function is the pathophysiological process underlying the natural history of type 2 diabetes [20, 21]. Consequently, as the UKPDS and A Diabetes Outcome Progression Trial (ADOPT) trials demonstrated, therapies that are based on stimulating endogenous secretion of insulin [e.g. sulfonylureas] are bound to fail when physiologically stressed beta-cells reach the limit of their ability to respond [22, 23]. As the Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial demonstrated, basal insulin used in the setting of dysglycaemia reduced progression to diabetes [24].
Unlike therapies such as sulfonylureas, which stimulate endogenous insulin secretion and therefore require progressively greater beta-cell response at the very time that their ability to respond is levelling off or decreasing, insulin therapy can theoretically provide some beta-cell rest. The potential beta-cell sparing action of exogenous insulin represents an opportunity to slow and maybe reverse beta-cell deterioration, with potential impact on the natural history of type 2 diabetes.
The closest they got was "maybe reverse beta-cell deterioration". This study was published in Sept of this year, but none of this appears to be new information from what I was taught. They even dismissed the tests that showed beta cell mass regeneration from GLP-1's.
They later qualified the study with:
It should be noted however that, in this trial, the goal was to assess the beta-cell sparing effect of early insulin treatment and so the investigators did not attempt to pursue a period of drug-free remission.
I appreciate you doing your homework, mnholdem. But this study does not claim (unless I missed that part... possible because I stopped reading after the intro) that insulin can regenerate beta cells.
Merry Christmas and happy New year to all!
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Post by stevil on Dec 17, 2015 15:36:56 GMT -5
I dont know but it feels different. Its seems like the tax loss selling pressure is over and the hedge fund shorts are covering to take some profits. How else are the hedge fund managers going to get their bonuses? Trend Volume is too low for it to be anything definitive. Probably just accumulation at this price with no driving force downward. I'd love to say correlation equals causation with Shkreli arrested, but the shorts have been covering for a while according to those who have been monitoring. Let's hope we found our bottom as there hasn't been downward pressure this week.
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Post by stevil on Dec 17, 2015 15:32:41 GMT -5
*In the event you missed my inference, I'll make it clear. In addition to the typical Wall Street power brokers, I think that some of the officials running certain government agencies should be considered to be included among those "other bosses" I mentioned above. As such, they will likely want this investigation to be handled quickly and be strictly confined to Martin Shkreli. Shkreli's antics could bring unwanted congressional light upon certain agencies, including public pressure demanding to know why they aren't doing their jobs. illuminati?
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Post by stevil on Dec 15, 2015 11:00:45 GMT -5
20% is around $100/ month, ya?
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Post by stevil on Dec 13, 2015 14:54:08 GMT -5
Ironic that the "do no harm" aspect of the Hippocratic oath, in this instance, involves providing the body with something it should produce naturally but cannot - human insulin. All because it's delivered through what is probably the toughest organ in the human body. Men and women can smoke their entire lives, and/or breath in pollution day after day yet the idea of inhaling a "powder" into the lungs raises a red flag for many. It's no mystery why MannKind called it Technosphere Insulin and why Sanofi calls Afrezza a "dry formulation". The idea that inhaling a powdered insulin (FDA's official description) is bad for you is another misconception that must be corrected by educating physicians and patients alike. In courses covering atmospheric chemistry and physics, very small particles (below a couple microns) are characterized as behaving like gases. The TS particles not only behave as gases for penetration, but also dissolve upon impact with moisture in the lung tissue. They dissolve, but leave residue. However, the studies I read showed virtually 100% clearance of FDKP, meaning TS won't be causing any lung complications, but whatever medication attached to FDKP may. However, insulin is a small enough protein to get absorbed in alveoli. This shouldn't be an issue. I need to check before making this statement, but I wonder if insulin is any larger than other inhaled steroids that are commonly prescribed for asthma. I can understand some hesitation but there should be enough docs that can be convinced to try it to build a strong base for momentum.
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Post by stevil on Dec 12, 2015 16:38:33 GMT -5
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Post by stevil on Dec 12, 2015 16:36:19 GMT -5
I maxed out my annual contribution, according to Scottrade, so now my couch cushion funding of MNKD shares have to go into my cash account. By taking the circuitous route of depositing in your conventional IRA and transferring to your Roth, can you get around the limit for annual contributions to your Roth that way?
Any tax lawyers lurking about?
I don't have a Roth, only 401ks and IRAs. It sure does sound like a very good time to c reate a Roth and transfer all my MNKD there. Time to actually talk to my broker. If you find a tax attorney on the board, let me know.. Could be some substantial work for him from a bunch of us. I posted earlier in this thread the backdoor to Roth conversion. It's legal and very effective. You just need to transfer funds first to IRA then to Roth. I don't have much money atm but I'm fairly certain there is no limit. It helps spreading it out over a few years though as any money you convert to IRA is immediately taxable. So if you don't want a huge penalty, spread it out over a few years so you can stay in the same tax bracket. Hope you're not already on the fringe.
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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.
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