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Post by brotherm1 on Aug 30, 2016 11:07:24 GMT -5
"Dangerous territory I would think. A "slip of the tongue" or a misspoken word and it can't be called back......"All that to make the point that i agree that no matter how frustrated he becomes, a executive at a company should not resort to commenting on message boards. It's just not a good look.....". I would say that for sure it is at least a different look. Most execs sit back with a cool look while collecting pay on the shareholders tab and then get outrageous bonuses and retirements regardless of how bad their company and stock perform. Mike is obviously not of that type. He is definitely determined to succeed. I'll take his passion over politically correct execs in $1,000 suits any day. I contend that people are tired of the current look.
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Post by sophie on Aug 30, 2016 13:14:34 GMT -5
I would also like to hear about the status of label changes (ultra rapid, fewer hypos). To me those are critical components of Afrezza's differentiation and superiority vs. competitors. And while they're at it, I would love to see them negotiate away the spirometry requirement, though that is probably a pipe dream. Or have the FDA impose a skin sensitivity test for anyone needing a shot to make sure they aren't going to react negatively to injections. Keep the playing field fair... The lungs and skin are both incredibly vital organs. But you cannot compare apples to oranges in that a localized section of skin may become irritated by multiple needle sticks, resulting in patient discomfort. This is a relatively minor injury. If the lungs become occluded, the blood cannot become oxygenated and the entire body suffers from hypoxia. The lungs are a much more serious concern. This is a revolutionary drug that challenges the status quo. People are afraid of what they don't know. On top of that, it's not viewed as being necessary- there are other treatments already available that essentially do the same thing. Something like this was never going to be adopted quickly. It needed time to prove why we need to change the way we approach diabetes. We're seeing glimpses of that from the meeting that was held yesterday. All we need is time. Let's hope we find the money to get us where we need to be. I hope we're not turning away partners at this point. Let's use Afrezza to open up the rest of our portfolio.
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Post by LosingMyBullishness on Aug 30, 2016 15:32:14 GMT -5
Dangerous territory I would think. A "slip of the tongue" or a misspoken word and it can't be called back, and everyone will presume he's speaking for the whole company. Better to issue well thought out press releases -- reaches more investors and less chance of error. I think at this point he has become one of us, a disillusioned and frustrated investor. Something that Matt has done a good job of avoiding due to his long term experience with MNKD and relationship with Al Mann - who he watched invest his blood sweat and tears (and a lot of money) into the success of this company. All Mike can see is the positives of a transformational drug that can help millions of diabetics. What he's missing is the fact that this company has been under attack for years by short sellers, and that unquantifiable and immaterial results (even though they may seem positive) will not do anything for the share price when there is big money out there that wants to see this company bankrupt, regardless of the positive effect Afrezza will bring to many. So now he is taking his frustration out on the small time bloggers who peddle negative nonsense about Mannkind daily. At the end of the day these bloggers have no actual effect on MNKD and no retail, hedge fund, or institutional investors listen to a word they write. All that to make the point that i agree that no matter how frustrated he becomes, a executive at a company should not resort to commenting on message boards. It's just not a good look. IMO SA article are not blogs, they are read by a lot of retailers and LFD has not been a small time Blogger but MNKDs most ressourceful and frequent basher. I assume that you are not familiar with social media for retail investors and that you base your opinion about what management should do on traditional code. That's fine but why not accept that Mike seems to see social media as one of many channels to investors?
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Post by anderson on Aug 30, 2016 19:24:05 GMT -5
Or have the FDA impose a skin sensitivity test for anyone needing a shot to make sure they aren't going to react negatively to injections. Keep the playing field fair... The lungs and skin are both incredibly vital organs. But you cannot compare apples to oranges in that a localized section of skin may become irritated by multiple needle sticks, resulting in patient discomfort. This is a relatively minor injury. If the lungs become occluded, the blood cannot become oxygenated and the entire body suffers from hypoxia. The lungs are a much more serious concern. This is a revolutionary drug that challenges the status quo. People are afraid of what they don't know. On top of that, it's not viewed as being necessary- there are other treatments already available that essentially do the same thing. Something like this was never going to be adopted quickly. It needed time to prove why we need to change the way we approach diabetes. We're seeing glimpses of that from the meeting that was held yesterday. All we need is time. Let's hope we find the money to get us where we need to be. I hope we're not turning away partners at this point. Let's use Afrezza to open up the rest of our portfolio. There are other inhaled drugs www.aaaai.org/conditions-and-treatments/library/at-a-glance/inhaled-asthma-medications"Inhaled corticosteroids, also referred to as topical corticosteroids or glucocorticosteroids, are anti-inflammatory medications that have been used successfully to treat asthma for over 50 years" Also think of all the dust, pollen, smoke, smog and everything else people breath in every day and the lungs filter this out and are not damaged. No compare that to TI which is almost entirely absorbed into the body and leaves very little residue in the lungs. I would like to see a comparison of the dangers of the morning commute to work in traffic and inhaling TI on a PPM, particle size and how far into the lungs each one gets. People forget the lungs and skin are filters and very good ones, yes you do not want to abuse them, but calling them delicate and treating them like they are extremely fragile in regards to the testing TI has went through should also be warning you about breathing smog and everything else which has unknown long term affects. Do you know where the air you are breathing has been?
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Post by sophie on Aug 30, 2016 19:53:05 GMT -5
There are other inhaled drugs www.aaaai.org/conditions-and-treatments/library/at-a-glance/inhaled-asthma-medications"Inhaled corticosteroids, also referred to as topical corticosteroids or glucocorticosteroids, are anti-inflammatory medications that have been used successfully to treat asthma for over 50 years" Also think of all the dust, pollen, smoke, smog and everything else people breath in every day and the lungs filter this out and are not damaged. No compare that to TI which is almost entirely absorbed into the body and leaves very little residue in the lungs. I would like to see a comparison of the dangers of the morning commute to work in traffic and inhaling TI on a PPM, particle size and how far into the lungs each one gets. People forget the lungs and skin are filters and very good ones, yes you do not want to abuse them, but calling them delicate and treating them like they are extremely fragile in regards to the testing TI has went through should also be warning you about breathing smog and everything else which has unknown long term affects. Do you know where the air you are breathing has been? You are correct. There are other inhaled drugs. There is one key part here that I think you might be overlooking though. An asthmatic doesn't have a choice on whether to use an inhaler or take a pill. I don't know enough about medicine to know if anything IM can be given, but the easiest and safest way to administer bronchodilators was through a propellant that acts directly onto the smooth muscle in the trachea. The same can't be said about insulin. At least not yet. The trials have shown that FDKP breaks apart at the pH of the lungs and is filtered by the kidneys and passes through the urine, but how do we know which is safer? To your next point- it would be better for us all if we didn't breath all that nasty junk in the air. Our lungs only want nitrogen and oxygen in and carbon dioxide out. Anything else could potentially be harmful. There has been increased incidence of lung cancers in urban areas where there is more smog. Just because we're already forced to breathe polluted air doesn't mean we should make matters worse and pile on more. There actually is a huge difference between the two. Injury to the skin from a needle will heal in a day or two. Injury to the lungs may be irreparable, depending on the injury. If you inhale something, it doesn't just stay in one spot like a needle. It spreads throughout the whole organ. Also, no one ever got cancer from sticking themselves with a needle. People have gotten cancer from inhaling things. All that said, I don't think Afrezza is unsafe. There have been lots of studies showing that it is. But you can't say that just because you breathe crap in all the time means it's ok to breathe in any crap. Otherwise, smoking wouldn't be harmful.
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Post by liane on Aug 30, 2016 20:29:33 GMT -5
sophieA few of your comments are not quite accurate. First off, I think its comparing apples to oranges when you compare inhaling Afrezza to breathing in smog. Afrezza is comprised of 2 components; the insulin is metabolized and removed from the body by normal metabolic processes while the FDKP is absorbed in to the circulation and excreted unchanged through the kidneys. There is no build-up, no carcinogenic potential shown in the over 10 years of study, and no damage to any of the tissues contacted. Smog, on the other hand, is a melange of particulates (which are not easily removed from the lungs), volatile organic compounds (with a variety of toxic and carcinogenic properties), and nitrogen and sulfur oxides (which form acids on contact with the moist environment of the pulmonary system). As to injecting your skin thousands of times over a lifetime, there is indeed damage to the subcutaneous tissue. Lipoatrophy (a reduction in the sub-q fat cells) and lipohypertrophy (an overgrowth of the fat cells) both can occur, and both can impair the absorption of the insulin injections. Diabetics learn to rotate their injection sites to minimize these effects, nonetheless, I've had older diabetic patients that no longer have good sites for injection. Your comments regarding "inhaling things" vs "injecting things" really are overgeneralized.
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Post by sophie on Aug 30, 2016 21:24:18 GMT -5
Hi liane,
I made no comparison between smog and Afrezza. I was replying to someone who did.
I'm not trying to make a snide remark, but you sort of prove my point in a way. Something that appears relatively harmless like stabbing yourself with a needle, if done enough, can cause damage years down the line that wasn't immediately obvious. This is more for my own curiosity and not to be snarky, but has anyone been on Afrezza for 10 years and used it every day? I've wondered if there is data for long term effects. Don't kill yourself to find it if you don't know where it is. I'm sure you have better things to do. I'm just curious.
Anyway, my point wasn't to say Afrezza was harmful if inhaled. We know that there are no immediate effects of it other than what, cough? My point was more that we should try to keep just oxygen and nitrogen in the lungs because that's all that they need. I know that FDKP is inert, but so were CFCs that I mentioned in one of my earlier posts. I'm sure you know this if you're a doctor- catalysts don't change in a reaction. They go in as one thing and come out the same way. I'm not sure how it's possible to track them all the way through the body to make sure they don't dissociate, but hopefully this was already taken into consideration.
I'm not really trying to argue a point. I'm just trying to say that we can't really say for sure what the long term effects are because it's still a relatively new drug. I invested in this company knowing all of this already. I've spoken to a few docs about why they won't prescribe it and they mention the required spirometry test makes them nervous. They don't want to cause harm to their patients. I'm not a doctor so I'm not going to tell you how you think, but the ones I've spoken to (PCPs not endocrinologists) say that adherence, lifestyle, and proper dosing is more the problem than the quality of the insulin. But that's probably because they figure the endos will fix the ones that can't keep their control down so they don't deal with the really bad ones.
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Post by tayl5 on Aug 30, 2016 23:16:17 GMT -5
Sophie, it's easy to consider that anything could have a long-term risk. Any drug ever approved could show an adverse effect if taken by someone for twenty years. The FDA approval process, when it works as intended, is designed to achieve a reasonable risk-reward outcome. There are some ultimately harmful drugs that get through, but if doctors and patients avoid all new drugs because they could eventually be harmful, medical progress stops and we're left with whatever harmful effects the unmet disease need is inflicting. In the case of diabetes, those harmful effects are pretty bad. Some Afrezza users like, for example, afrezzauser, have been dosing themselves for years with no ill effects.
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Post by sophie on Aug 31, 2016 0:05:43 GMT -5
That's the point I've been trying to make that keeps getting detracted from.
I am of the opinion that the risk/reward of Afrezza isn't understood well enough to merit its prescription. To the docs I have spoken to, the risk of cancer or whatever isn't as great as the reward. They don't appreciate what makes Afrezza that much better. I hope we have enough time to get them there.
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Post by babaoriley on Aug 31, 2016 0:18:52 GMT -5
sopie, I think you've been making your point since your first post (right now, 26 posts ago). Most here are too polite to be snarky, I am not.
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Post by liane on Aug 31, 2016 5:41:43 GMT -5
That's the point I've been trying to make that keeps getting detracted from. I am of the opinion that the risk/reward of Afrezza isn't understood well enough to merit its prescription. To the docs I have spoken to, the risk of cancer or whatever isn't as great as the reward. They don't appreciate what makes Afrezza that much better. I hope we have enough time to get them there. Your statements contradict themselves. Did you mean "proscription" vs "prescription"? Or did you mean the risks outweigh the reward?
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Post by bill on Aug 31, 2016 21:04:18 GMT -5
That's the point I've been trying to make that keeps getting detracted from. I am of the opinion that the risk/reward of Afrezza isn't understood well enough to merit its prescription. To the docs I have spoken to, the risk of cancer or whatever isn't as great as the reward. They don't appreciate what makes Afrezza that much better. I hope we have enough time to get them there. Your statements contradict themselves. Did you mean "proscription" vs "prescription"? Or did you mean the risks outweigh the reward? And to pile on just a little bit... How about looking at the risk/reward of using Afrezza to obtain near-normal blood glucose levels versus the tangible, quantifiable damage being done DAILY to EVERY diabetic that's using insulin analogs because those drugs and treatment modalities cannot be used safely to achieve near-normal blood glucose levels.
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Post by Deleted on Sept 1, 2016 21:13:57 GMT -5
Hi liane, I made no comparison between smog and Afrezza. I was replying to someone who did. I'm not trying to make a snide remark, but you sort of prove my point in a way. Something that appears relatively harmless like stabbing yourself with a needle, if done enough, can cause damage years down the line that wasn't immediately obvious. This is more for my own curiosity and not to be snarky, but has anyone been on Afrezza for 10 years and used it every day? I've wondered if there is data for long term effects. Don't kill yourself to find it if you don't know where it is. I'm sure you have better things to do. I'm just curious. Anyway, my point wasn't to say Afrezza was harmful if inhaled. We know that there are no immediate effects of it other than what, cough? My point was more that we should try to keep just oxygen and nitrogen in the lungs because that's all that they need. I know that FDKP is inert, but so were CFCs that I mentioned in one of my earlier posts. I'm sure you know this if you're a doctor- catalysts don't change in a reaction. They go in as one thing and come out the same way. I'm not sure how it's possible to track them all the way through the body to make sure they don't dissociate, but hopefully this was already taken into consideration. I'm not really trying to argue a point. I'm just trying to say that we can't really say for sure what the long term effects are because it's still a relatively new drug. I invested in this company knowing all of this already. I've spoken to a few docs about why they won't prescribe it and they mention the required spirometry test makes them nervous. They don't want to cause harm to their patients. I'm not a doctor so I'm not going to tell you how you think, but the ones I've spoken to (PCPs not endocrinologists) say that adherence, lifestyle, and proper dosing is more the problem than the quality of the insulin. But that's probably because they figure the endos will fix the ones that can't keep their control down so they don't deal with the really bad ones. Something that appears relatively harmless like stabbing yourself with a needle, if done enough, can cause damage years down the line that wasn't immediately obvious.— Injecting yourself multiple times daily is relatively harmless? So these doctors that you keep mentioning that are worried about potential future lung problems regarding Afrezza, were they the same ones that never thought about an obvious future problem with injections? Also, have they even read the studies regarding Afrezza? Clamp studies? This is more for my own curiosity and not to be snarky, but has anyone been on Afrezza for 10 years and used it every day? I've wondered if there is data for long term effects. Don't kill yourself to find it if you don't know where it is. I'm sure you have better things to do. I'm just curious. — Afrezza has not been available for 10 years. My point was more that we should try to keep just oxygen and nitrogen in the lungs because that's all that they need. I know that FDKP is inert, but so were CFCs that I mentioned in one of my earlier posts.— What are you suggesting? That our lungs only need oxygen and nitrogen? What about all the other things you breathe into your lungs? argon, CO2, neon, helium, Methane, krypton, nitrogen oxide, hydrogen, xenon, and….Ozone? I'm not really trying to argue a point. I'm just trying to say that we can't really say for sure what the long term effects are because it's still a relatively new drug.— Yes, you are trying to argue a point. You have brought this up more than once. If you are that worried about companies are trying to put into peoples lungs I suggest you advocate the crumble of Big Tobacco and the FDA and everyone else involved with mass murder. I invested in this company knowing all of this already. — Sounds like you still have a lot of doubts. I've spoken to a few docs about why they won't prescribe it and they mention the required spirometry test makes them nervous. — Sounds like the docs you know/speak to are close minded and prefer to stick with what they were taught. Did you know that a spirometry test is actually a very common test performed in the hospital and in clinics? Also: those same docs probably prescribe several drugs (pills) just because they get a free lunch (speculating here, but speculating based on fact). They don't want to cause harm to their patients.— I disagree, and will also add: They also don’t want to join present day innovation. I'm not a doctor so I'm not going to tell you how you think, but the ones I've spoken to (PCPs not endocrinologists) say that adherence, lifestyle, and proper dosing is more the problem than the quality of the insulin.
— This applies to so much more than just diabetes. This is just an EXCUSE, and nothing else. But that's probably because they figure the endos will fix the ones that can't keep their control down so they don't deal with the really bad ones.
— Wrong. Plenty of PCPs deal with difficult diabetics. Fact.
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Post by mannmade on Sept 1, 2016 21:26:08 GMT -5
I have posted this before but seems relevant again... I had dinner with Sam F and he told me regarding the lung safety issue the following:
"When I weigh the chance for the POSSIBILITY of cancer or other lung issues related to using AFREZZA which have yet to show themselves in any statistical meaningful way (with all the testing of 1,000's of patients over the course of the trials) versus the CERTAINTY that with my Hba1c in the 10''s (he admitted to being out of control most of his life despite a rigorous work out regime and watching what he ate) prior to starting AFREZZA (he is now in non-diabetic range) that I would likely go blind, suffer kidney and heart damage and loss of limbs... It was really a very clear choice for me.
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Post by afrezzamiracle on Sept 1, 2016 21:46:41 GMT -5
Sam Finta eloquently said it all right there!
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