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Post by brotherm1 on Aug 5, 2019 19:24:53 GMT -5
Since we don’t have the money for studies to step up in the standard of care; and since we don’t have money to market sufficiently or help sponsor the FDA (edit: ADA) to a significant degree: we need a new CEO. We need an extremely attractive financially well-off female CEO to get things done the old American way.
Like it or not, it’s still who you sleep with that matters most.
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Post by sportsrancho on Aug 5, 2019 19:26:23 GMT -5
Since we don’t have the money for studies to step up in the standard of care; and since we don’t have money to market sufficiently or help sponsor the FDA to a significant degree: we need a new CEO. We need an extremely attractive financially well-off female CEO to get things done the old American way. Like it or not, it’s still who you sleep with that matters most. WTF! Lol
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Post by brotherm1 on Aug 5, 2019 19:32:28 GMT -5
Someone apparently stole my moniker.
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Post by brotherm1 on Aug 5, 2019 19:34:54 GMT -5
Honestly, I do like the new billboards and other marketing without the Afrezza name and the associated black box. Perhaps we finally found a good way to advertise without too much cost.
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Post by georgethenight2 on Aug 5, 2019 20:21:29 GMT -5
Okay What do we have to do to increase prescription numbers? No needles is great isn't it? I mean who would rather take a freaking shot. Lower A 1c, just as effective or more so than any other diabetes medication. Less hypo's sleep throughout night with less worries of never waking up again. FDA approved study cohort for 4-7 year olds would FDA allow this if they were really worried about stupid blackbox warnings. What bullshit those warnings are. This drug should be a homerun are endocrinologists stupid and lazy? They have taken a hippocratic oaththat dictates to do whats best for patients. What am I missing the stock price is wprse than ridiculous it is criminal. Let me help. MNKD sales rep. Only 1 drug to sell. Advertising. We just dont do it! Special interest. Doctors just as corrupy as polticians. DF. Ah good ole DF. Cant shake them no matter how much we try. Runway. An eventual raise/funding will take place, uncertainty. Truck load of BS. HFM, VDEX, MC, MK, board, stockholders fighting each other. Personally, I like MKs price targets, $20~$40 in the near term. The problem is we need to have a huge uptake in rxs and the goddamn pipeline needs to me built out. That being said. Good points. International. Brazil and eventually others. Afrezza. Its a HELL of a drug! Technosphere. Martine likes it. Increased word of mouth. FB group surpassed 1000 members last month. Funding. Rumor on ST is refinancing is taking place, non dilutive. RXs. I think I can I think I can.
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Post by stevil on Aug 5, 2019 21:21:32 GMT -5
If you want to know why a doctor doesn't prescribe, ask a doctor. There are many on here with loud voices that have no knowledge of what they speak or live in an alternate reality to the one I live in. Be careful whose voice you listen to. Really, it's not that hard to understand... Just open your ears to the ones who know what they're talking about. It will make much more sense. So what are the reasons and what can be done about them? Sorry I’m sure you’ve told us before. I'm not sure you want to ask me what can be done about them because I don't think many on here will like my answer. It will take creativity beyond what I possess to make Afrezza the blockbuster so many expect. MNKD is between a rock and a hard place because they must prove superiority if they hope to claim it. That will be very expensive. I don't foresee Afrezza overcoming this barrier without a large scale trial or the passing of several years with favorable results on CGM. Until then, they'll just be a niche product for the few whose insurances cover it and can afford to pay the premium. (as a whole) Doctors overlooking Afrezza has nothing to do with collusion or "the good ol boys" club. It has nothing to do with laziness on the part of doctors. While some may call it either of these, that is not the heart of the issue and it is my opinion that they are not just slightly wrong, but wrong by a very wide margin. The heart of the issue is multifold. RAAs have been proven. They have been tested, retested, and then tested again. This is particularly important regarding dosing instructions. RAAs have a known profile while it seems Afrezza's is still being discovered. That uncertainty alone is enough to put doctors off. Not because they're lazy or stupid, but because they're not going to use their patients as guinea pigs when they have a tool they know and trust already that has been, up to this point, been proven to be just as good. The same goes for metformin. Contrary to the opinion of some, the medical community loves metformin and has produced countless studies outlining its numerous benefits. Cost is a huge issue in healthcare, especially in a system as broken as ours (although cost reducing measures would be even greater in a single payer system). Metformin will forever be the first line therapy because it is $4-$8 a month, depending on dosage and where you fill your rx. I'm not sure any evidence will ever surface to justify the order of treatment being different. People can (and do) go decades on metformin without much more than neuropathy and probably a slightly increased chance of coronary artery disease and stroke. It seems there is a huge disconnect between the people of this board and people with diabetes as it pertains to the impact medication cost has on a system. The highest incidence of diabetes is with African Americans, particularly those with lower incomes who usually make poor food choices. Healthy food requires more time, effort, and money than cheap and easy junk food. This means there are literally millions of people who cannot even afford to pay for any insulin, let alone the massive premium Afrezza requires. I have made this point before to the chagrin of so many on the board- metformin and sulfonylureas are a godsend to these people as they would probably die decades sooner without them. The cost burden is only getting exacerbated as younger and younger children are now getting diagnosed with type 2 diabetes, meaning the number of years per person requiring treatment is also increasing as people are getting diagnosed younger and living longer. As far as insulin goes, Afrezza has only proven to be "non-inferior" to RAAs. In a doctor's mind, that means inferior since you have to pay a premium for the same results. Therefore, by default, it gets categorized as a niche product- only those who fear needles and are willing to pay a premium to avoid said needles will get a script. Even beyond this, doctors think in terms of risks and benefits. What is the risk associated with a medication compared to the benefit it provides? So far, the risk with Afrezza is unknown. What is known is that it contains a black box warning and had a spirometry requirement. There was also a link to lung cancer with Exubera (another member in its class, right or wrong) that Afrezza may or may not be able to overcome. The benefits are inhaling vs injecting, which for most people with diabetes I have talked to isn't much of an issue at all. Thus, you have potentially a ton of risk without much proven benefit. The STAT trial was a start, but it proved that Afrezza still caused hypoglycemic episodes, just like every other insulin- only the time spent in hypoglycemia was shorter. While that is meaningful, it will still make it "less safe" than metformin, since metformin does not have any effect on insulin secretion, only increasing sensitivity to insulin. In other words, it cannot induce hypoglycemia. As I have said before, there are thousands of medications on the market that are FDA approved. It is not laziness on the part of doctors if they are not familiar with all of them. It's simply not possible to know every medication through and through. Not even pharmacists know every medication on the market thoroughly and their scope is much narrower and focused solely on medications. The best way to learn medications is to clump them into classes. SSRIs, beta blockers, ace inhibitors, cephalosporins, fluoroquinolones, etc... One learns the class and then learns what differentiates one drug vs another member from its class. Most docs pick one or two medications from each class that they will prescribe. It simplifies things. It allows them to learn the characteristics of the one medication and appreciate the nuances of one medication rather than multiple others that ultimately do the same thing. There are guidelines and trials that would suggest the use of one drug over another member in its class for certain uses, if needed. Otherwise, they are all the same for all intents and purposes. In case I have lost you by now, I'll try to simplify it as it pertains to Afrezza. Afrezza has been characterized as either a RAA or ultra-rapid insulin. The way for Afrezza to differentiate itself from other insulins in its class is to have trial data that proves its superiority and demands its use. Otherwise, it will get lost in the crowd if the trial data says it is only as good as other insulins in its class. Insurance companies generally don't care if you're afraid of needles. Comfort will not determine standard of care. Results and cost will. They are in the business of making money and only care about the bottom line. Again, I have seen this mentioned here before. It is the way it is and it will not change unless a single payer system overhauls our current one. For those wishing for this to happen, it would likely eliminate all hope for Afrezza outside of proven long term benefits that reduce later costs associated with comorbidities (heart disease, stroke, neuropathy, etc). I have seen aged talk endlessly about people with diabetes not wanting to think about their disease. He/she is right. Believe it or not, another trial would need to be done, or a meta analysis of a huge conglomeration of data points to prove increased adherence- more people take their insulin and have proven better results in an entire population vs just a single trial- before Afrezza would become standard of care. In other words, this will not happen quickly, even if everything aligns perfectly. As dumb as it sounds, trial data not only needs to support that something is possible, but that it actually does happen as well. For instance, those who only take 1 dose of Afrezza may not have better results compared to one dose RAA'ers. If the increased dosing burden is too high amongst an entire population so much so that the population has worse results with a superior product, it will still not be recommended as standard of care. It would be best for MNKD to find a way to prove superiority with just a single dose rather than a second, extra dose as this will not only increase cost burden, but also the added burden of an extra dose with every meal. While I will not claim infinite knowledge to say the "insulin cartel" does not have political power to ensure their dominance in the industry, I will say that I feel very strongly that this is not the case. Is capitalism to blame and might that be the culprit? I would say this is the case a hundredfold more so than under the table dealing. The way insurances work is that manufacturers make contracts with PBMs and offer discounts to gain exclusivity. This makes it extremely difficult for a new medication to penetrate the market. The best way for MNKD to overcome this is to design a trial that beyond a shadow of a doubt proves its superiority in A1c reduction and increased TIR. Then, after that has been done, to price Afrezza according to other RAAs, unless they can prove with data that their increased cost is justified. Theoretical ideas hold little to no merit. I have a feeling that even if Afrezza does gain superiority, RAAs will drop their price and make it harder to justify using an insulin that is much more expensive. The problem is, no matter how much better Afrezza can be than RAAs, it will be very difficult to justify its use if it is so much more expensive. There is something called "number needed to treat" that is a metric researchers use in order to justify the use of medications amongst a population. If that number is too high, meaning it would take thousands of people to only have a few live better lives, the end may not justify the means. In other words, it doesn't make sense to place an additional strain on the market for a marginally better drug when spending millions extra would rob far more of basic care. For example, $1 million would allow 250,000 people to take metformin monthly vs about 10,000 on Afrezza. The numbers have to justify the cost burden. Right now, they do not. I don't foresee MNKD ever doing so, but will be pleasantly surprised if it can ever be proven. The numbers above assume $1000 monthly for Afrezza vs $4 monthly for metformin. I think the average humalog/novolog monthly rx costs between $250-500 for reference. So in summary, it's: 1. There is not enough compelling data right now to support use of Afrezza vs other RAAs 2. The risk hasn't proven to outweigh the benefit 3. The cost hasn't proven to outweigh the burden 4. Even if 1, 2, and 3 are proven, the vast majority of people would either still not have access to or be able to afford Afrezza How to fix: 1. Fund an expensive well-designed clinical trial to prove superiority as well as small number needed to treat for cost burden purposes 2. Wait several years for the cream to rise to the top and for all the data to eventually find its way (assuming favorable results with Afrezza usage)
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WTF
Aug 5, 2019 22:00:56 GMT -5
od likes this
Post by ktim on Aug 5, 2019 22:00:56 GMT -5
I don't believe perks have dried up. They just went underground. A deep dive into the financed of the doctors would be required to prove it. Nobody has the stomach for that. Hence, the cycle continues. Pharmas still pay some docs to give talks and to serve on advisory boards. All that info is readily available. But that is relatively small number of "influential" docs. I've talked to sales reps when the crackdowns started occurring that complained about having to faze out dinners, rounds of golf and gifts as a sales technique, so I tend to believe that has actually changed. Do you personally know of sales reps that routinely give gifts/kickbacks or doctors that accept them, or are you just cynically believing it has to be the case?
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Post by sportsrancho on Aug 5, 2019 22:04:44 GMT -5
Stevil, Thank you.. it seems like we need a grant and a partner. Big money..and BP
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Post by sayhey24 on Aug 6, 2019 5:28:18 GMT -5
Stevil - about the only thing the RAAs have proven is they are too dangerous to prescribe as first line or second, third and even fourth line care for T2s when we know early insulin intervention is the best approach for T2 treatment. Afrezza studies have shown significant reduction in the chance for severe hypos.
As far as studies we had the STAT last year and the Baltimore study this year. One Drop also showed the same. Afrezza wins time and again when not under dosed. When under dosed as in the Affinity One its non-inferior but with significantly lower hypos. More large scale studies will show the same. The horse has been well be beaten.
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Post by barnstormer on Aug 6, 2019 6:53:14 GMT -5
Has everyone forgot about the Black Box warning. It would seem that Kendall and all of the MNKD studies he touts could get that changed.What efforts are being made? Dr.s see that as an easy excuse not to prescribe for whatever their real reason may be. Perhaps they are really concerned about a potential suit brought by a patient. Perhaps they just don't want to change their treatment to one with a Black Box warning. If I were a person PWD I would insist that my doc prescribe Afrezza or I would find a new endo and tell them why I was changing. After all they are working for me. I pay the insurance for the office visit and the drugs. I would say screw the Black Box warning I want Afrezza as my treatment. I think too many PWDs are willing to take take no for an answer. Whatever the doctor's reason for resisting a prescription the final decision/responsibility is with the patient who wants it. Doctors aren't gods, though many think they are. (Present PB members excluded)
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Post by mnholdem on Aug 6, 2019 7:22:43 GMT -5
The “horse” being a superiority study?
There is another pathway available, one that MannKind tried to get on its label and which was rejected by the FDA. That would be a new classification of insulin: ultra rapid acting. As I recall, the FDA explanation was that classifications must be developed by the scientific company and agreed upon by the medical community rather than defined by the FDA alone. However, while Afrezza would certainly fit within this class, have sufficient scientific studies been conducted and published which define the benefits of speed?
Arguably this area of science still appears to be in its infancy. Al Mann often spoke on the topic of how Afrezza emulates the actions of a healthy pancreas. But what does that mean and why is it important for control of diabetes? Why is the speed of initial insulin release (aka first pass release) important and how does affect glucose production and even insulin sensitivity?
After decades of diabetes treatment the medical community is only beginning to understand how using A1c alone to gage treatment effectiveness is inadequate and yet A1c remains the primary measurement.
Afrezza has been “proven” (STAT was defined as a small-scale pilot study that requires further large-scale clinical study) to excel at helping control Time in Range but TIR is not yet the primary measurement physicians use for assessing patient results.
A superiority study with significant reduction of A1c as the Primary Outcome and significant improvements of emerging key measures as Secondary Outcomes is essential for Afrezza to get the recognition (and label) needed to stand out as the gold standard of insulin treatment.
Stevil is correct in pointing out that such a trial would be expensive.
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Post by akemp3000 on Aug 6, 2019 7:31:31 GMT -5
I'm not buying what a few are trying to sell here. RAA's have been proven...to not work! It's common knowledge that current standards of care are not and have not been effective in getting diabetics to achieve an acceptable A1c or time-in-range. As the former Chief Medical Officer for the ADA, Dr. Kendall knows more about the rules, processes and probably politics for standards of care than have ever been openly discussed on a message board. He knows Afrezza is far superior to the existing options that he once referred to as antiquated and barbaric. IMO, there is highly likely activity going on behind the scenes to move Afrezza forward and improve the standard of care. One guess as to many possible paths is that Dr. Kendall and Mannkind first wants to have in their hands the documented results that will come from CGMs, One Drop education and BlueHale monitoring. With that, a fast track change should be possible. I wish Mannkind would provide an update though I could see how that might be counterproductive. GL
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Post by mnholdem on Aug 6, 2019 7:52:19 GMT -5
Then shouldn’t MannKind be doing a better job of communicating this fact? CMO Kendall certainly indicated early, after being hired, that MannKind would be going in this direction when he publicly described current SQ insulin treatments as “antiquated and barbaric”.
Great message, so who subsequently caused the CMO to shut up? The FDA? If so, then MannKind’s CEO is weak.
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Post by akemp3000 on Aug 6, 2019 8:13:18 GMT -5
Then shouldn’t MannKind be doing a better job of communicating this fact? CMO Kendall certainly indicated early, after being hired, that MannKind would be going in this direction when he publicly described current SQ insulin treatments as “antiquated and barbaric”. Great message, so who subsequently caused the CMO to shut up? The FDA? If so, then MannKind’s CEO is weak. I agree it would be good to hear more communications but it's possible that communicating Dr. Kendall and Mannkind's plan could be counterproductive. Broadcasting a company's strategic plan to the FDA, ADA and even competition could potentially be far more harmful than providing the plan to pacify investors. I have more confidence than most that both Mike C and Dr. Kendall know far more about everything than we'll ever learn. IMO, their plan will win in the long run. And yes, I too am tired of such a long run.
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bkdmd
Researcher
Posts: 79
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Post by bkdmd on Aug 6, 2019 8:32:42 GMT -5
Great conversation here. Personally I think we are entitled to answers from the CEO and CMO. We deserve better.
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