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Post by stevil on Apr 8, 2019 10:30:28 GMT -5
AAFP usually has good resources that (I think) is at least understandable by most educated laypeople. Here's an article on the complexity of the disease and different treatment options www.aafp.org/afp/2016/0915/p463.html
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Post by stevil on Apr 8, 2019 10:20:57 GMT -5
It's my understanding of PAH that there are progressive treatments depending on the severity of the disease. Remember that Viagra was first developed for the indication of PAH, so there are still oral formulations for early stages of the disease (Revatio) with progression to inhaled medications for moderate disease and then IV drugs for severe disease.
All that to say, I'm not in research, so I won't speak to the prospect of TreT being a "one size fits all" therapy, but if it's to be so, it will take extensive trials like we're seeing with Afrezza. It's really hard to put a value on TreT without seeing trial data and the extent of its indication. One would think it would be better than current moderate treatment, but whether it replaces severe therapies remains to be seen. Simply because it acts as an injectable drug by entering the bloodstream through the lungs does not mean it will be as efficacious as other intravenous molecules. Trepostinil is a much older drug and advances have been made since its creation.
As with most things on this board, be wary of the complete naysayers and the cheerleaders. The truth probably lies somewhere in the middle. Right now, we should expect TreT to replace Tyvaso's sales, assuming UTHR pushes hard and educates doctors. Whether it will extend far beyond that is unknown.
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Post by stevil on Mar 31, 2019 10:42:12 GMT -5
When a ProBoards member posted the MannKind’s Investor Relations Director replied that the company doesn’t know why scripts aren’t rapidly growing, I nearly sold all of my interests in this company. Frankly, I was so amazed that I thought the IR reply had to be false. Amazed that they told the truth, are that inept, or that they realized their ineptitude? Frankly, I’d be amazed at any other answer that they gave because if there was a reason they were aware of that they haven’t addressed, it would be gross negligence. I think it’s becoming undoubtedly clear all the things you’ve said - management is top heavy, Mike C is being forced to run errands he’s not supposed to, either because other players aren’t picking up the slack or he’s such a micro manager that he can’t stay on task and complete the bigger picture. From my vantage point, I think Mike C is an extreme micro manager and thus gives poor direction to his subordinates. He maybe has realized this about himself and has tried to compensate by hiring a bunch of upper level executives that can help cover this weakness. However, there isn’t a singular direction, so no one knows exactly what they’re supposed to be doing. Look no further than how many different directions we’ve seen this company be taken over the past 3 years. Unfortunately, I don’t think they have a clue. It’s been said here a few times that it appears they’re throwing ideas at the wall to see what sticks and they’re still not finding any solutions. Mike has become visibly frustrated on his Twitter. I’m not sure what else to call that than weakness. Men who are in control and are executing according to plan have no need for frustration. Really, how far has MNKD come since Mike took over? Besides keeping the lights on, all he’s done is added to potential with very few tangible and productive results. Take away TrepT, and there would be little if anything to hang his hat on. Even with TrepT, his spending has been a net negative and will continue to be so into the foreseeable future. I’ll concede I may be too harsh on Mike, especially with how easy it is to be critical from my position, but truly, where it counts, what has he really done thus far? Anyone can hit the dilution button to keep the lights on. He deserves credit for keeping the market interested by increasing MNKDs potential, but he has had plenty of time to create results greater than we have seen. His last adventure to spend our way into relevance will likely be just as wasteful as the ones before it.
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Post by stevil on Mar 21, 2019 1:22:13 GMT -5
He didn't mention anything about it putting him or his colleaguesout of a job as a reason not to prescribe? Stevil - why would the endo at this point in time be concerned about afrezza putting him out of a job? He already has the PWDs a patients.
The endo at the Adcom who made the comment about afrezza putting him out of a job was saying so because he saw a future where the PCP would prescribe afrezza as Step 1 for the T2s. He knew afrezza would stop the progression and by doing so the T2 PWDs would never need an Endo which were 90% of his business.
PCPs manage insulin already, not sure why an easier insulin would put endos out of a job. No one can predict the future with any certainty, but my crystal ball is telling me that Afrezza may eat a little into the endos schedules, but they've got lots of overflow to take from before they notice the difference. Afrezza seems nuanced enough that it may put off PCPs from trying to master it. If there's a sizeable market for VDex, endos have nothing to worry about, especially if Afrezza becomes first line (which I don't see happening). If that scenario played out, there would only be millions more to treat. PCPs probably wouldn't want to manage diabetes all day and would just refer out to the endos to take care of it. Prevention is the biggest threat to endos. If the dirty secret about how unhealthy the FDAs food pyramid is gets out, then they'd be in trouble. Otherwise, there will likely never be a shortage of patients, unless they saturate the market with NPs, PAs, or PCPs. All indications are pointing to that not being the case for the baby boomer generation and Gen X'ers. Even my generation of millennials still increased the growth rate. The demand for PCPs is higher than is currently being filled by the data I have seen. All signs are pointing to a shortage. Long story short, a shortage of PCPs means they're not going to want to turn into an endo and manage diabetes all day long. There will be plenty of job security for all parties involved.
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Post by stevil on Mar 20, 2019 18:49:47 GMT -5
Peppy,
I admit, I sometimes have difficulty looking away from a pot that's calling to be stirred, especially when I got tarred and feathered so much in the past for no jumping onto the conspiracy theory bandwagon. This site is much more readable now that those theories are starting to become more and more scarce.
I won't argue that money corrupts, nor will I argue that there aren't parties interested in the failure of Afrezza, although I don't think they feel threatened yet. I think it's interesting that MK says that posters on SA and message boards don't influence stock prices, and that he has instant credibility simply because he is pro Afrezza and for no other reason. It's been an interesting lesson in human behavior on here, for sure. People choose to hate people they'd otherwise like in real life if not for their perspective on Afrezza, and admire people who might otherwise be scumbags only on the basis of their commonality on one issue. It's just really interesting...
In response to your post, I won't argue with your post. I will say, though, that I don't think it matters. Medicare should far and away be MNKDs biggest insurance entity to go after and they have made little to no headway there thus far. I don't think it matters what rebates are being given out because scripts haven't grown appreciably with increased coverage. Co pay cards should help with the discrepancies between tiered coverage. Prescribers just aren't prescribing for the reasons that were shared in the OP.
Again, just been super interesting watching things come full circle on here and watching truths become so only after being validated by a friendly voice.
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Post by stevil on Mar 20, 2019 17:25:06 GMT -5
I had my annual, complete physical endo visit yesterday. This April will be 4-years using Afrezza and I was the first one prescribed Afrezza by my endo who has been in practice for 40+ years. Four years ago I had to talk him in to prescribing for me. Now, the Afrezza pamphlets are front and center, top row of his literature section in the waiting room. In his exam room, he had seven or so wrapped inhalers sitting close by, presumably to offer to patients who might want an Afrezza test run. - My Hemoglobin A1C 5.7. Last year, 5.6 (A1C Now, home tests generally run 5.1 to 5.7) Total cholesterol 179, HDL 82, LDL 84, Triglycerides 57, Non HDL Cholesterol 97 I give all of the numbers because I have no idea how Total Cholesterol is derived. - My doc also had Afrezza sample packs readily available where in the past I recall that samples were no longer being provided to doctors offices. - I didn't want to ask the direct question of how many folks he might be prescribing to, but it came up in our overall conversation and he stated he is prescribing to many now. He did mention that the docs in his field are reluctant to prescribe due to unknown lung function issues that might happen going forward. I told him, "fear of the unknown vs how I feel and quality of life...almost normal A1C, much much easier to manage my BS levels, fewer hypos to get that A1C and it's a no-brainer for me." He stated that he was at a conference where Afrezza was a topic of conversation among colleagues and he stated that he told them about my successes with Afrezza (not mentioning my name of course). Bottom line, he is not reluctant to prescribe now and he has been a top endo in Northern California for a very long time. Slowly, slowly, Afrezza is catching on. He didn't mention anything about it putting him or his colleaguesout of a job as a reason not to prescribe?
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Post by stevil on Mar 16, 2019 10:44:32 GMT -5
I thought Lilly couldn't help MNKD succeed because Afrezza would put them out of business?
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Post by stevil on Feb 4, 2019 14:03:40 GMT -5
Not sure if you’re asking about insulin storing glucose as fat or the documentary. The volume of information medical students need to learn doesn’t lend much time to pseudoscience or unproven science, unless the professor is personally involved in active research, either themselves or in a particular field. So the answer to the first is yes, to the second, no. Quote: Not sure if you’re asking Reply; I am asking, was it ever presented you as a medical school student, that insulin resistance is caused by too much fat in the cell? secondary to that was it ever discussed that, if you get rid of the fat in the cell, you get rid of the dis ease.? A two part question. now not on the down low, the for all to see, Yes, it was taught that way. I’m not sure if this is a trick question or not because it’s been a well-documented fact for a long time. Obesity has been linked to diabetes for a long time. If you measure someone’s blood insulin levels (before beta cell failure) they produce far more insulin than the “normal” population. It’s why the prevailing hypothesis is that beta cell exhaustion leads to progression of the disease and ultimate failure to produce insulin in late stages of the disease.
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Post by stevil on Feb 4, 2019 13:49:57 GMT -5
type one is our market. I have heard this chit about type two for years. they will cut their stomachs out. we can't hone in on type twos for the reasons you have laid out. on the down low, for you stevil.... I have come to see the truth in this. www.screencast.com/t/eqw5x3lTULU1Any mention of this in medical school? Not sure if you’re asking about insulin storing glucose as fat or the documentary. The volume of information medical students need to learn doesn’t lend much time to pseudoscience or unproven science, unless the professor is personally involved in active research, either themselves or in a particular field. So the answer to the first is yes, to the second, no.
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Post by stevil on Feb 4, 2019 13:04:37 GMT -5
reply: Stevil, type one diabetes, Insulin is not optional is my understanding. Have things changed? How about LADA, any new orals or injectables for LADA? Type two's need to change the food attached to their fork. Any mention of that in medical school? eh? There seems to be plenty of people using fast acting insulin. 27 Apr 2018 Afrezza----495 $632k 277 $380k Apidra----6520 $4.95m 2254 $1.77m Novalog--137k $132m 56.0k $57.8m Humalog-151k $139m 60.3k $58.0m Humalin--37.4k $20.5m 14.9k $8.0m 1:06 PM - 11 May 2018 Type 1s need insulin, yes, but they make up less than 20% of the total diabetes market, and shrinking. If you’re mannkind, it’s certainly a good group to go after, but you really want to hone in on the type 2s. I sometimes get PTSD thinking about anything pre-step 1, but I’m pretty sure I posted on the board when I was learning about diabetes 1st year that diet and exercise is by far the best first step for type 2s. Problem is that poor diets and lack of exercise is what gave most people the disease in the first place so it’s hard to change bad habits. Some people are able to, most are not. Im not saying insulin is going away, by any means. Time in range, as has been talked about, is gaining in momentum. I simply meant that the bridge to insulin is getting longer in a sense in those who stay below 7 A1c. Current guidelines do not suggest starting insulin until 7 and I have seen resistance as high as 8 from doctors. I don’t think I can convince anyone on here about this, but I’ve said in the past that the best treatment isn’t always the best treatment. Sometimes you need to tailor it to the individual. If compliance is an issue, you don’t want someone on a medication 3-6 times a day. For those who are motivated (which type 2s are notorious for not being), you can give them Afrezza. Otherwise, it’s much easier for patients and physicians to take a pill 1-2 times daily or a shot once weekly or surgery. Insulin, currently, is losing favor as more options arise. It’s purely seen as the last resort. Afrezza is not going to change that stigma anytime soon, again, pending unforeseen circumstances. I’m not dismissing its potential to by any means, just the timeline that some on here think it will happen in.
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Post by stevil on Feb 4, 2019 8:52:02 GMT -5
From someone with clinical experience, I don't fully agree with your post. I do agree that we're heading in that direction, but it will still likely be at least a couple years out. There are simply too many patients that cannot afford $7/day for insulin related expenses. Diabetes type 2 is significantly skewed towards those with less education and lower income levels. Also keep in mind that people with uncontrolled diabetes are not just on insulin. They are also at least on blood pressure, statins, and neuropathy pain meds. While none of those others are terribly expensive, it is not a cheap disease. Things will not change quickly unless/until Medicare and Medicaid programs start to accept Afrezza and it gets more accepted as the standard of care. Should be intuitive, but just in case it's not, the older you are, the higher chance you'll develop the disease. Medicare needs to jump on board and coverage for Afrezza is abysmal to non-existent. Medicare is covering CGMs, but it will likely take a couple years of seeing that injected insulin is still inadequate before looking for the solution. Your opinion vs mine, but from everything I've seen, pending some unforeseen circumstances, it will be another couple years minimum before I see traction really starting to change. MNKD still hasn't even fixed the awareness or perception of inhaled insulin yet. They're making strides, but without a mega budget to push it, it's not going to change soon. Expect a continually gradual slope like we've been seeing with a slightly steeper slope now that they're finally fueling the marketing machine. There are still too many barriers that need to be lifted. I don't know how much progress Mike has made with insurance companies, but after listening to his recent podcast, he didn't sound too optimistic about the changes. The TLDR version: it would be inappropriate to recommend MNKD as an investment based on Afrezza alone unless you want to put faith in a behind the scenes miracle... It's up to anyone to judge the risk/reward aspect for themselves, but for those expecting Afrezza to pave the way into the near future, I think they're going to be disappointed. stevil were your clinical rotations part of a city or county hospital and/or their outpatient clinics? All of the above. I’ve had the amazing opportunity to rotate at academic institutions, county, and rural locations. My school offered me both options- I could either stay within one system or I could travel and be apart of many. I chose to travel, hoping to see more pathology. There was one commonality amongst all locations. Afrezza was not on anyone’s immediate radar. More had heard of it than I was expecting (especially at the academic institutions... as you would hope) but there were few that had heard of it that wanted to learn more. I probably had the most success when I was able to present on Afrezza and really get into the details with mostly naive listeners, who were also predominantly residents, so that’s probably why - clean slates, so to speak. The old saying, “you only get one chance to make a first impression” is especially true in medicine. Once you learn something a certain way, it’s incredibly difficult to shake that understanding. Reason being, one needs to be confident in what they know as a doctor. You can’t second guess yourself or be unsure. That’s why I think it will take overwhelmingly convincing data to truly swing the pendulum, although it is obviously just my opinion. If I’m still being trained as a medical student after all these years that insulin is dangerous and should only be used as a last resort, think about the perception the docs have that used to prescribe nph insulin to their patients. An even bigger problem I’ve been seeing is that insulin is really getting blacklisted now with all the various other options. Treatment is heavily shifting towards GLP-1s, DPP-4s, SGLT2s, and the like since they’ve come out with various other benefits related to CVD and overall mortality. (And I’ve run out of stamina to argue them, so anyone- sayhey, mango, etc- go look them up for yourselves. I didn’t make up the data so i don’t want to defend it. It is what it is) Big pharma paid for those results. They compared them against insulin, so it will take a complete re-education of Afrezza insulin to prove why it’s different. This is where I think overwhelming data is needed. But that all takes a long time to test, compile, then publish. I’ve been waiting with bated breath for Dr. Kendall to show us something we haven’t seen yet, but he’s been eerily absent.
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Post by stevil on Feb 3, 2019 15:42:52 GMT -5
Sports - hang in there. It has taken a really long time but the medical community is now just starting to feel the pressure of seeing BG numbers in real time. We all know there are only two ways to treat the post meal sugar spike; not eat the food; take the afrezza. Afrezza will have its day. It won't be in 6 months but Mike is making progress and so is Dave Kendall. At the same time CGM technology adoption is rapidly growing and costs are within reach of most even with no insurance. For $4 a day for the afrezza and $2.80 a day for a Libre sensor we are now under the price Kevin Johnson is selling a cup of coffee and a doughnut. In the mean time maybe Kevin with give us news on RLS to extend the runway. From someone with clinical experience, I don't fully agree with your post. I do agree that we're heading in that direction, but it will still likely be at least a couple years out. There are simply too many patients that cannot afford $7/day for insulin related expenses. Diabetes type 2 is significantly skewed towards those with less education and lower income levels. Also keep in mind that people with uncontrolled diabetes are not just on insulin. They are also at least on blood pressure, statins, and neuropathy pain meds. While none of those others are terribly expensive, it is not a cheap disease. Things will not change quickly unless/until Medicare and Medicaid programs start to accept Afrezza and it gets more accepted as the standard of care. Should be intuitive, but just in case it's not, the older you are, the higher chance you'll develop the disease. Medicare needs to jump on board and coverage for Afrezza is abysmal to non-existent. Medicare is covering CGMs, but it will likely take a couple years of seeing that injected insulin is still inadequate before looking for the solution. Your opinion vs mine, but from everything I've seen, pending some unforeseen circumstances, it will be another couple years minimum before I see traction really starting to change. MNKD still hasn't even fixed the awareness or perception of inhaled insulin yet. They're making strides, but without a mega budget to push it, it's not going to change soon. Expect a continually gradual slope like we've been seeing with a slightly steeper slope now that they're finally fueling the marketing machine. There are still too many barriers that need to be lifted. I don't know how much progress Mike has made with insurance companies, but after listening to his recent podcast, he didn't sound too optimistic about the changes. The TLDR version: it would be inappropriate to recommend MNKD as an investment based on Afrezza alone unless you want to put faith in a behind the scenes miracle... It's up to anyone to judge the risk/reward aspect for themselves, but for those expecting Afrezza to pave the way into the near future, I think they're going to be disappointed.
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Post by stevil on Jan 17, 2019 15:44:48 GMT -5
That's really funny. My state is very well represented. I'm going to go ahead and pat myself on the back and pretend I'm having a profound impact.
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Post by stevil on Jan 11, 2019 15:41:46 GMT -5
Keep in mind that these patients are probably highly motivated. I guess I'm not completely sure how it works- if the patients seek out VDex or if they're referred by their physician. I also don't know their protocol, but if they're only using Afrezza, it would require at least one dose with every meal or snack as well as any random spikes that might happen, although I'd imagine those probably don't happen often if the PPGE are well-controlled. In any case, all VDex's results tell us is what is possible, not what is likely to happen. The full equation still includes the variable of patient compliance and, unfortunately, that's the most important part of the equation. The best tool in the wrong hand is worthless.
It's still a lot of work and attention to ask of someone to spend monitoring their disease every day. For those who care enough to do it, they now have the ability to. I don't see Afrezza being any easier to dose than metformin (pulling out a cartridge, loading it into the inhaler, inhaling, taking cartridge out vs swallowing a pill in the morning and evening) and compliance with metformin isn't even that good. It's really sad, but there is still a significant chunk of the population that no matter how easy you make it for them to take their medications, they won't do it. The problem with diabetes (type 2) is that it takes so many years to really cause a lot of problems and it's not often that you have to look out for any acute type of events. Patients think they don't need medication if they feel "normal". Of course normal tends to drift over time but slowly enough to where it takes awhile before they start paying attention to it. Preventative medicine is sometimes a very hard sell- you're asking your patients to spend more money and be more disciplined now for better results later. Delayed gratification is becoming taboo in our culture.
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Post by stevil on Jan 10, 2019 20:06:32 GMT -5
Yes, every doctor I’ve spoken to that had heard of Afrezza. I have not yet run into a prescriber of Afrezza. On the flip side, the blank slates I’ve talked to, the ones I get to make the first impression on, say they’re impressed and they’ll follow the story once it gets better insurance coverage. The presentation I gave generated a lot of interest because I got to present Afrezza the right way. I showed why a faster insulin was needed by showing how much more area is under the curve of RAAs, why postprandial excursions are so vital to A1c, and how Afrezza could radically transform treatment with its tight control. I’ve probably spoken to 30 or so doctors about Afrezza. I’d say around 40% had heard of it. So, around 12 gave that opinion. I have yet to meet a doctor who both had heard of Afrezza and had a high opinion of it. Which is a shame because a couple were really interested in diabetes treatment and spent considerable time researching Afrezza. They came away unimpressed with the data that’s floating around out there. Stevil, in about 18 months the flood gates are going to open on CGMs. Abbott's Libre already has 1 million users and Dexcom is working on a new sensor that is smaller, thinner and less expensive that the G6 (which is a very good product). In addition to the T1 market, the new sensor will have applications for T2 as well as prediabetes, gestational and inpatient and they are partnered with Verily (Google's health arm). My belief is Amazon will get into the game too. In short, once enough patients are wired up with CGMs, the fact that most are poorly controlled will be glaring and it will become well known that the standard of care is substandard. Time in range and reducing peaks and valleys in blood glucose levels are the pieces of information that a CGM can provide. A1c is going the way of the buggy whip. In a fee for outcomes world, guess how much the doc gets for a patient with poor control of blood glucose levels? Preaching to the choir my friend! That's what my recent presentation was about and the general way I went about it. I basically used CGMs to show why a better insulin was needed, described Afrezza's unique characteristics and why/how it would meet that need, then showed the few CGMs I could find with people on Afrezza to show that it does... I'm not sure why people think I'm anti-Afrezza? Edit: I strongly hope that fee for outcomes does not impact outpatient specialties. It totally makes sense for procedures, surgeries, and inpatient- there's not much excuse for poor outcomes there unless the patient was a poor specimen to begin with. Outpatient, though, doctors have absolutely no control over their patients habits or decisions. It would be unfair to punish them for things outside of their control.
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