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Post by stevil on Mar 22, 2016 20:11:37 GMT -5
It appears the FDA would require that, yes. They have been less than lenient so far, so that would be my best guess... That is, if we wanted to make claims about reduced chance for opathies... but I suppose I can't make that claim for them. Maybe they will be satisfied simply with the lowering of A1c. I hope so
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Post by stevil on Mar 22, 2016 19:59:42 GMT -5
stevil, You said: People think that Afrezza is the only insulin that lowers A1c. They all do. That's the point of taking insulin- to lower blood glucose levels. . .Neuropathies sometimes take decades to manifest.My take is that it is not about lowering A1c to a certain average value that is important regarding neuropathies. It is the avoidance or shortening of intervalls of high A1c values. My guess (and yes, I am not aware of a study that substantiates this) is that every time period of high A1c has a negative impact on the nerves. Over time this accumulates to a major defect which is then interpreted as neuropathy. The A1c is important because it is elevated levels that do the damage rather than spikes. Since an A1c is the result of the average level over a three month period it tells you what that level is running at. A low A1c means a low average and a lower risk of neuropathy. Shortening elevated levels is not really helpful for neuropathy if the average level is still high. LosingMyBullishness, yes, you are correct. High glucose at any moment is harmful and can cause damage, although I'm unaware if they've pegged "high" to a specific number as there are several different causes for why glucose spikes are thought to cause opathies. There are so many pathways, both hormonal and metabolic that rely on glucose for their signaling and it's still an advancing field. Not everything is well known at the cellular level yet. This might mean that the current prandials may be doing an adequate job in this department. Basals have also come a really long way and may be just as important in lowering A1c as a good prandial, but I'm not sure. Like I said, opathies take a long time to manifest, so it won't be known for some time how well or if our current line up is curtailing this problem. Unless they have pegged it to a certain number through microscopic analysis, it's quite likely that the current regimens are "doing the job" as far as the opathies go. Only time will tell pending better testing methods. However, like agedhippie said, the more important number is A1c, since it's a number that shows the average concentration. Again, that's what is taught right now because that's what's been studied. Who knows if it'll be proven that the first phase is actually when most of the damage is done... but to my knowledge, this hasn't been tested yet, although I suppose they could have compared results over time with other prandials as they've gotten quicker... So it's possible....
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Post by stevil on Mar 22, 2016 18:08:34 GMT -5
I respectfully disagree. HgbA1c shows chronic blood sugar elevation while there growing basic science evidence showing glycosilation from extreme sugar levels leads to the inflammation and vascular damage. Afrezza is the only insulin to address the posprandial spike. My investing mistake was to assume that Mannkind and Sanofi would take immediate action post FDA approval to show superiority in the arena of posprandial blood sugar control and bring awareness to diabetics and physicians in conferences exactly like the above link. Ha I know the science. Glycation is measured by A1c. A1c is an average measurement of the glycation of hemoglobin (red blood cells) in the body. This should be reflective of the average concentration of glucose in the blood over a period of time. People think that Afrezza is the only insulin that lowers A1c. They all do. That's the point of taking insulin- to lower blood glucose levels. The other thing that people don't appear to understand is that insulin has improved leaps and bounds over just the past 15 years. Neuropathies sometimes take decades to manifest. This means that the current line up of insulin will likely show lesser incidence of limb damage over the coming years. Progress has already been made in lowering A1c so it can be expected that we should see fewer opathies related to diabetes. I don't think that people understand the rationale of the scientific community. Things sometimes move slowly because they don't want to make the mistake of thinking correlation equals causation. Meaning, just because something appears in all diabetics (high blood sugar) doesn't always mean that it's what's causing disease. Obviously in this case we have reason to believe that correlation is, in fact, causation. But only because further study lends credence to those results. Once you find a link, you test it further to see if it's the actual cause. Why do I say all of this? Because the current metric physicians use for severity of diabetes is the A1c test. Does it make sense that decreasing spikes in blood sugar during its peak time should lower A1c? Does to me... However, nothing is taken for granted. The truth of the matter is we've never been able to test diabetics consistently (as far as I'm aware anyway) with an insulin that mimics the kinetics of a pancreas. The way to make waves is to be able to have data that backs up that theory. Data is collected during studies. Once data is collected, judgements can be made. I know that many on here will tell me that Afrezza has already shown that it lowers A1c better than any other insulin. I'm not the unbeliever here. I don't need much convincing, and I don't suspect many doctors would either. However, you can't use social media bloggers as proof. First, you don't know that they're being honest in their results. Second, you don't know if they have been more compliant with their therapy, if they changed their diet, if they exercise more than other diabetics, etc. There has to be a credible, conclusive study done that isolates Afrezza as the sole cause for lowered A1c. If a study is done and it is shown that Afrezza is no more successful at lowering A1c levels than other insulins, it's going to be difficult to place importance on its speed, other than decreased hypoglycemic events compared to other insulins (which also hasn't been tested yet). Again, it will be a surprise to no one if those results are proven after a study, but you can't claim it until you do that study. All this to say, we still need more tests to be completed before our voice can be separated from the herd. Unfortunately ours still blends in to some extent. Saying that your insulin works really quickly isn't as effective as saying it lowers A1c and reduces hypoglycemic events better than any other insulin on the market. Again, we can't claim either until we have data that backs it up FDA grants us permission to do so.
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Post by stevil on Mar 22, 2016 16:45:15 GMT -5
We need to show (and prove through clinical studies) that Afrezza lowers A1c levels (cause of neuropathies) better than anyone else before we can have any sort of differing voice at these kinds of conferences.
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Post by stevil on Mar 19, 2016 19:27:08 GMT -5
^ I can't speak for the whole market, but this is the reason why I jumped back in. As long as we don't go BK, our chances of making it obviously increase, which should then also increase our value as a company, even though the most important technical indicator, i.e. profitability, is still likely a long ways away. I think you are correct though... I don't think the bullish move is as much an indicator of our impending success as much as it is a change in sentiment around our survival. At least I hope so I hope that we're all getting it right and BK rumors can go by the wayside. Matt said that there were things he could not discuss right now that would help alleviate BK, but he said something to the effect of more needed to be done in order to become profitable. So it doesn't sound like anything major is going to be announced, just that death isn't around the corner like we (I) had previously feared.
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Post by stevil on Mar 19, 2016 19:22:08 GMT -5
As the self-appointed voice of reason, (FYI, I have turned bullish on this stock and bought in at 1.43, I think), let's not forget that the price moving upwards has no real merit yet. My only fear is that more people will dump more money into this thinking we've now become a sure thing, or even better than 50% chance that we'll survive. I believe the poster James had a bunch of really good and neutral posts about what all we need to do still in order to become profitable. We still have to overcome a $100 million/year loss in order to turn a profit. Many people think this is an easy feat since we have a superior drug. If that were the case, big pharma wouldn't unload the bank trucks into their marketing campaigns if it wasn't necessary. I realize that a partner would help with this cost, but even if Afrezza exceeds $100 million in its first year of sales, there's no way MNKD gets the full share of the profits. Certainly we'd still be forced into a somewhat unfavorable deal as the partner would assume all the risk. Wherever there is high risk, there must be promise of high reward, otherwise no one would do it. Furthermore, our situation is not a simple 50/50 proposition and there are many, many more factors that actually are working against us to decrease our chances of success. We still need to educate doctors. We still need to get ins to cover our medication (making each unit less profitable as a consequence, making profitability "harder" to do, without taking into account the increased demand from a lower price, granted). We still need to convince diabetics that our product is better than any other out there, etc, etc. Truly, I love the optimism. Let's just not get carried away yet. There is a lot of positive momentum at the moment, but as baba said, this could all halt as quickly as it started. I just hope people aren't getting bullish hangovers and losing their wisdom and caution. May everyone only risk as much as they're comfortably able to... As mnholdem says, Good fortune to all
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Post by stevil on Mar 18, 2016 15:49:08 GMT -5
Mar 18, 2016 11:17:07 GMT -7 stevil said: Glad the longs are recouping some of their losses. I got in around 1.40 range because I think this will run til 4/5. Not sure if I'll sell then or not.Take the money and run. If there is any mistake I have repeated too often in my life it is being unwilling to take a fast profit and be happy. In what way could MNKD possibly be worth $1.5 - $2B as your price target suggests? It's on track to lose $100M or more per year in perpetuity even if it is still in business next year, only hype and hope are holding it up at the moment. A week ago it was just over $1 and the only thing that has changed is that they hired a marketing manager. I hear ya, and believe me, there probably hasn't been a bigger skeptic of this stock than me over the 8 months or so. I know the "right" move would be to take profits and run. However, if we are afforded a runway, it'll be the last chance we'll probably ever have to get shares at this price. Right now, 10k buys you 5000 or so shares. If I take profits and run, and this goes to $10 or so, that same 10k only gets you 1000 shares. So I'd lose out on a multiple of 5 by selling (or maybe only 3 if it does indeed go up to $3). Matt hasn't won me over with his confidence, although it does have me intrigued that our new CCO would leave a well-paying position with far more security to chase after what many analysts have written off as a pipe dream. If there's one thing I don't bet against, it's the motivation of determined and talented people. There's very little doubt in my mind that if they are given enough money for 3 years or so that they'll get this thing straightened out. So really, it really only boils down to one thing in my mind. Will they simply be able to survive long enough to figure this out? I used to think no, but I'll admit that there is more reason to think "yes" than "no" right now. I'm not sure how so many on here are finding so much comfort in Matt telling us he can't disclose his plan... but there is one, especially when he's been a leader in the company for several years. I do get the sense, though, that he has had a different vision for MNKD the whole time and it was either Hakan or Al that didn't agree. He just seems completely emboldened in a different way. That much you can't fake. So maybe it is Matt's confidence and maybe it is the board's optimism that is causing my change of heart. Maybe it's the recent momentum back to the top that's making me euphoric. I'd already written off all the money I'd invested in this company. I think at the most I would sell the extra I just put in for a profit and keep the original investment in and let it ride. A lot to think about, for sure. Not nearly as black and white as I was expecting...
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Post by stevil on Mar 18, 2016 13:17:07 GMT -5
Glad the longs are recouping some of their losses. I got in around 1.40 range because I think this will run til 4/5. Not sure if I'll sell then or not.
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Post by stevil on Mar 8, 2016 13:45:51 GMT -5
2 questions, both, I'm sure are fairly obvious to everyone.
1. Where in the world are they getting all this money? 2. Why didn't they have any of these positions before? Or were they let go to save money and are not in the process of expanding the workforce again? Are we actually making progress right now or is this some sort of CYA/pre-sale counsel?
Hoping Matt was genuine about transparency... sure would like some right now.
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Post by stevil on Mar 8, 2016 13:24:16 GMT -5
Just a quick look tells me this smells fishy.
They misspelled the acronym for our technology FDKP (fumaryl diketopiperazine). Not sure what FPDK is...
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Post by stevil on Mar 2, 2016 12:39:08 GMT -5
Sorry iam2, I can't stomach a long post with the history of what it took to get her on Afrezza right now. If you look in my history you'll see me talk about it going back to around Oct/Nov. Right now I'm just beside myself!!!! As she is texting me today, so happy, with a new goal of a non-diabetic 5.7, and how she couldn't have done it without me convincing her and her ENDO.... And I can't stomach to tell her how much of our $$ I've lost over this miracle drug..... OH YEA!!!!!!!! Let's not get too wrapped up in the amazing A1c after 10 weeks, or how she feels, or that she can predict her bs better than ever, without remembering that she goes to bed EVERY NIGHT with ZERO fear of a midnight hypo!!!!!!!! And it doesn't sell? The company is worth $1. This is a fu@?ing joke!!!! You said it yourself. "what it took to get her on Afrezza". That's why we're at $1. Hopefully the new management team can eliminate all or, at the very least, most of the hurdles in our way. It doesn't matter how great a drug is if no one can get it.
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Post by stevil on Mar 2, 2016 12:35:52 GMT -5
If there's anything to take away from this, wouldn't it be that there aren't plans of selling the company currently in the works? Wouldn't it be kind of pointless to do all of this if they weren't at least trying to keep the ship afloat?
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June 7
Feb 27, 2016 20:03:36 GMT -5
Post by stevil on Feb 27, 2016 20:03:36 GMT -5
haha kindred spirits on that one! It's hard for me just to fast until lunch time to get my lab work done.
Sorry to take your joking post and make it serious, but fasting and more importantly, adherence to the rules is actually very important to Muslims as they view their lives on a scale, essentially hoping that the good outweighs the bad and they're allowed to enter into heaven. Fasting during Ramadan is actually one of the 5 pillars of their faith, so it's incredibly important to them. I don't really know exactly how it works, but I'm thinking it might mean that they'd have to "make up" the slack in other areas and work harder to tip the scale back in their favor. Never really thought about it. I'll have to ask one of my Muslim friends what the dogma is on it, if there is one.
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Post by stevil on Feb 27, 2016 19:15:50 GMT -5
I'm not understanding why people are ditching their pumps when they still take a basal? Is it just because they don't want to have something clunky attached to them and would trade that freedom for the cost of injecting? next stop, inhalable basal insulin haha. Afrezza + tresiba combo pack. Probably when the patent expires.... That's usually how these things go... For those interested in the Lilly pump, I did a quick search and found this. diatribe.org/bionic-pancreas-dual-chamber-pump-unveiled-friends-life-2015And a couple mistakes in my previous post. I guess you type in more either, snack, small, medium, large meal and then you're done. Something like that. No carb counting. www.healthline.com/diabetesmine/cwd-friends-for-life-2015#4
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Post by stevil on Feb 27, 2016 18:56:49 GMT -5
Sorry to pick on you, but I take issue with people that talk like this on here. I have no idea if you're diabetic, but if you are, I have a hard time imagining you'd say something like this. For people like my uncle who grew up without a pump, he feels like he's a free man with his pump. I tried to tell him about Afrezza but he was perfectly content with his pump so he didn't even listen to me. Does it get better than a pump? Yes. Is no pump better than a pump? Yes. Forgive my candor, but you sound ignorant when you talk like this. And it's self-talk like this that I feel many people deceived themselves into thinking Afrezza was more than it was. Afrezza doesn't even remove the necessity of a pump for crying out loud! Pumps are wonderful things! It's the closest diabetics have gotten to "normal" since the beginning of time. It's not the destination, but it's certainly a significant step in the right direction. Please don't downplay its significance. I am not downplaying pump.. I am just saying pump is not normal... You wouldnt know the freedom until you have gone pump free I am not diabetic, so fortunately I've never been shackled to one. It sounds like you are now pump free and I'm very excited to hear that! Congrats. I hope many people share the same success you have with it!
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