|
Post by dreamboatcruise on Jan 12, 2018 17:14:45 GMT -5
Can't provide link but the deal exists. Data is the measurement stick which in the future will determine how much $$ healthcare provide will get paid. NPV for healthcare costs on non-compliant patient is much bigger than the cost of the Rx. How much is laser eye treatment, how much is surgical procedure for amputation and subsequent costs to take care of patients. CV issues, bypass, etc. Renal failure?dialysis. In 5 years, will patient have economic skin in the game, gain share for compliance, cost share for non-compliance? True about NPV at a societal level. However, most insurers do not consider the NPV of long term costs for the reasons I stated... the benefits of long term costs savings may well accrue to a different payer, either another insurance company or Medicare, and the fact that execs at most insurers, as with most all companies, have monetary performance incentives based on short term results not long term. Medicare does have Value-Based Payment Modifier program that covers diabetes. However, it is based on current total per capita cost. So doctors would be put in the situation of needing to increase current costs (such as prescribing insulin sooner rather than metformin), which would work against their immediate financial interests since per capita cost would be higher in short term, betting on the patients they are helping stay healthy might still be with their practice long down the road when the cost savings from fewer complications kick in. I'd love to learn that Medicare had pay for performance for diabetes based on a near term metric such as A1c (or better yet time-in-range... but we know that isn't the case since they only recently approved CGMs and certainly don't require them), but in researching just now I didn't find any pay for performance for diabetes other than this Value-Based Payment Modifier. I believe this Value-Based Payment Modifier does not apply to Medicare Advantage programs. Those would fall under the same business dynamics of any other commercial insurance. I'm not knocking the idea of pay for performance, but even if the change will eventually happen it may be slow... and I don't think the healthcare industry will do this without being forced into it, and with political dysfunction I don't have huge confidence that healthcare will be forced to change. Are we two steps forward one step back, or one step forward two steps back.
|
|
|
Post by dreamboatcruise on Jan 12, 2018 15:53:09 GMT -5
"Technical analysis is a method that applies to take a guess of future price trends through analyzing market action." IMHO technical analysis is wonderful for traders, not so much for investors as it places too much emphasis on the past. I don't see consideration for the high probability that scripts and therefore the pps will likely jump in the near term because of the most recent marketing push. "Technical analysis is a method to foretell the future originally developed at Hogwarts, and generally considered an art not accessible to muggles."
|
|
|
Post by dreamboatcruise on Jan 11, 2018 20:38:56 GMT -5
I think Al may have been too generous in his view of the medical community when stating that "there is increasing pressure to move patients much sooner to exogenous insulin" when in reality it seems the focus is as much as ever on creating new non-insulin drugs to postpone insulin initiation. But if that is a quote from Al, you can't edit it.
Only thing I'd take exception to outside of Al's quote, is the second to last paragraph. The way that is worded makes it seem as if MNKD invented Recombinant Human Insulin. Would suggest...
"Al Mann set his sights on the development of an insulin that could better mimic the rapid onset and clearance of endogenous pancreatic insulin and thus provide greater time within target range for blood glucose. After decades and more than a billion dollars, the result was "Afrezza", a mechanism of stabilizing recombinant human insulin in a form that can be delivered into the deep lung through inhalation and rapidly pass into the bloodstream."
If it were me, I'd want to see some reference to Al stating that "natural" was something he considered Afrezza before using that term. Mimicking the pancreas in first phase release, yes... but from what I know of Al, he wouldn't have claimed Afrezza was "natural" or had that as a goal in the first place. I suspect he viewed it as a marvel of engineering, rather than natural. Open to correction if he really ever said something about Afrezza being a more "natural" form of exogenous insulin. Might be picking nits, but "if it walks like a duck and quakes like a duck, it is a natural duck" isn't going to hold true once we have android ducks.
|
|
|
Post by dreamboatcruise on Jan 11, 2018 20:14:48 GMT -5
Seems interesting that some of these low projections for slow, steady growth to continue are making the assumption that the label change, TV show, TV ads and One Drop suggesting to its customers that they try Afrezza will have no effect at all. Can't imagine that happening. I'm not saying that they won't have an effect, but just playing devils advocate... we may be limited currently by how many "writers" we have. Perhaps the doctors that are prescribing are tending to bring it up to all their patients as an option even if the patient is unaware of Afrezza... and doctors that aren't yet on board tending to not be receptive to it even when patient have learned about it elsewhere. An extreme case of that I certainly doubt would be the situation, though I think this effect will still present a bit of uphill battle even with advertising. Personally I think these marketing moves are great (actually long overdue) and are bound to move the needle in scripts. For me it is hard to predict how quickly the needle is moved, which will primarily be determined by whether patients that learn of Afrezza through these marketing/advertising mechanisms go into doctors not yet prescribing Afrezza and enough docs are open minded that we start getting a much larger pool (including PCP) that are seeing the superior clinical results of Afrezza. Hopefully the label change is turning out to be a meaningful tool for the sales reps talking to doctors. Would love it if MNKD were to have a time graph on number of "writers" and really show that the label change is having an effect.
|
|
|
Post by dreamboatcruise on Jan 11, 2018 20:03:00 GMT -5
I use to update the inhaled insulin wiki but a few days later it would get changed back to the current stuff. I just looked and its as bad as ever. It led me to believe there was an organized effort against afrezza, just saying. I will try and update it over ther weekend if I have time or unless someone beats me to it. However, IMO its almost a full time job and should be done by the MNKD web guy. It would seem with the label change it would be hard to dispute pointing out the speed of action difference. In the past even that could have been disputed if it were not carefully worded to say pk rather than pd since label previously had the confusing notion that it got into system quicker but then didn't produce action quicker. I can understand why bar would be pretty high for drug wiki pages... with the editorial view of better to lack info than present info that turns out to be wrong. For instance I would assume a claim like "Afrezza is safer than any other mealtime insulin" would be rejected unless there is a reference to a peer reviewed source with a conclusion such as that. In the past have you had references for each "claim" you tried to include regarding Afrezza? Bear in mind, your edits could be thrown out summarily regardless of accuracy if the editor is aware of you being an investor in MNKD. The frustrating thing is that some editors may have their own personal opinions, if not a verifiable financial conflict of interest, that makes it hard to get fair portrayal.
|
|
|
Post by dreamboatcruise on Jan 11, 2018 19:50:05 GMT -5
Technically anyone with a financial interest in something should not be contributing to the wiki page, according to their policies. Not that I'm suggesting that anyone flaunt their rules surreptitiously , but if it is clear that an investor is editing it, that would be easily contested if there is someone wishing to cause trouble. There are layers of "editors" where stuff is adjudicated. Let's say you were to create wiki account to contribute and used "xanet" as your username. Someone could look at the edit history and appeal to the editors providing a link to posts here where you say you are an investor. So in summarizing, investors should not be editing Afrezza wiki page I would apply your thinking to the Endo Consensus and Standards of Care rather than a wiki page. Those two are polluted with financial conflicts of interest and directly impacts and affects the lives of PWD. Total corruption. Wikipedia is far more concerned with accuracy than ADA [perhaps it should be at 45 deg angle, since I'm only half joking]
|
|
|
Post by dreamboatcruise on Jan 11, 2018 17:45:20 GMT -5
This just seems like low hanging fruit. There are plenty of knowledgeable people on this board who could put all of their research efforts to work to tell the world about Afrezza. What a great opportunity for investors to write the story of this paradigm-shifting product! Lack of awareness remains a huge problem, and here's our chance to help change that. Again, I don't have the knowledge to pull it off, but I don't think this needs to be left to professionals, and no one has to write the whole article. Even a well-crafted sentence or two could really improve on the information that's out there now. Technically anyone with a financial interest in something should not be contributing to the wiki page, according to their policies. Not that I'm suggesting that anyone flaunt their rules surreptitiously , but if it is clear that an investor is editing it, that would be easily contested if there is someone wishing to cause trouble. There are layers of "editors" where stuff is adjudicated. Let's say you were to create wiki account to contribute and used "xanet" as your username. Someone could look at the edit history and appeal to the editors providing a link to posts here where you say you are an investor. So in summarizing, investors should not be editing Afrezza wiki page
|
|
|
Post by dreamboatcruise on Jan 11, 2018 16:41:20 GMT -5
So Mannkind should just sit on their hands and wait - just like every other time... geez, not even trying. No... they should just do it from their home computer so it's not traceable, as I'm sure almost everyone else does
|
|
|
Post by dreamboatcruise on Jan 11, 2018 16:31:18 GMT -5
Injectable insulins, especially RAAs, are unstable, contain numerous additives, and have erratic and slow absorption—all of which consequently allows for it to easily degrade/misfold. This is why injectable insulins can cause a serious condition known as localized insulin-derived amyloidosis. With Afrezza, there is none of those issues. Afrezza is a stable monomeric insulin whose kinetics mimic intra-arterial administration. There has been zero incidence and/or evidence to date regarding insulin amyloids within the pulmonary tract from use of Afrezza. Put simply—Afrezza is the safest insulin, as well as, the best prandial insulin in the world. I think you're getting ahead of what the literature says about "why" insulin amyloids form at injection site. It could be that taking insulin directly from someone's pancreas (if feasible) and injecting it subq would cause the same. Insulin amyloids occur in the pancreas itself for people with diabetes regardless of insulin treatment (according to at least one source I've read)... so it certainly is possible for insulin amyloids that have nothing to do with small differences in RAA vs what the body produces. Who knows, perhaps if TS Insulin were injected subq it might also illicit that response in some. You are correct that no evidence of amyloids in lungs has yet to be reported with Afrezza. That may simply be that it is transported so quickly into blood stream it doesn't stick around in high concentrations in the lung long enough to invoke whatever process results in amyloids. Lack of amyloid possibility may thus be benefit of route of delivery. On the flip side the theoretical issue with lung deliver is insulin antibody development, though this was looked at extensively with Afrezza and so far seems to not be clinically relevant... though some chance long term studies would have this pop up as a quite rare issue of concern. At least that is the only outstanding safety issue I personally believe is a credible one. I would also perhaps question use of "serious" with regard to insulin amyloidosis. It is considered rare (though perhaps under reported), and most seem to believe that more frequent rotation of injection sites would prevent it for the vast majority. Additionally, the main complication is that it can mess with insulin absorption if one continues to use an injection site where it has formed. But obviously "serious" is in the eye of the beholder. [Edit: Between the three of us, I think we could write a good tutorial on insulins. Though I suspect the three of us would be the only ones interested in the final product.]
|
|
|
Post by dreamboatcruise on Jan 11, 2018 15:20:57 GMT -5
I'm guessing 1.
NO... it's not FUD... I just assume we're playing by Price is Right rules.
|
|
|
Post by dreamboatcruise on Jan 11, 2018 15:17:26 GMT -5
quote; unaccompanied by all the other hormones and similar that a human pancreas produces. Aged, as a type one diabetic, does the pancreas still push out the pancreatic enzymes? (I know I should look it up) Normally, a healthy Pancreas will secrete about 8 cups of this pancreatic juice each day. This juice contains both pancreatic enzymes for digestion and bicarbonate to help neutralize stomach acid. pancreatitisfacts.com/pancreatic-enzymes/Gulp. I never thought about that, but I suspect it does or I would have bigger problems. There are other things that don't happen or are blunted with Type 1 c-peptide, amylin, and glucagon to an extent (glucagon response is blunted). I am not sure about some of the peptides, typically they seem to be blunted. Typically you hear that beta cells are the ones being attacked by immune system in T1. Those are responsible for insulin including the c-peptide which is a fragment byproduct of insulin production. Glucagon is produced by alpha cells so if that is also blunted it would imply either immune system is also killing them off or there is some dependency of their action on proper action of beta cells. The endocrine functions of the pancreas are carried out by the islets of Langerhans cell clusters (alpha, beta, gamma and delta cells). The non-endocrine functions, such as enzyme production, are from other cells within pancreas, which I'm pretty certain are not being attacked by immune system in T1. I wonder if there are rarer forms of autoimmune where the other pancreatic cells are attacked... it seems there is hardly any type of cell in the body where there isn't possibility for auto-immune attack. It is curious why some cells are much more susceptible to having autoimmune response develop. I don't think they've really figured that out conclusively though I think the answer is being pursued by many. I have one of the autoimmune diseases, so always been interested in following new research in the field.
|
|
|
Post by dreamboatcruise on Jan 11, 2018 14:13:59 GMT -5
Actually, mannkind themselves should get on this and do it themselves. There's no reason Afrezza doesn't have a good entry already. Having a factual wikipedia entry would be great when people google Afrezza. Wikipedia always ranks near the top of google searches which would be better than bullshit motley fool articles. They have a general rule that says that a company shouldn't write the articles about themselves or their products because it is considered conflict of interest. That rule would also say Sanofi or Novo employees shouldn't write or contribute to Afrezza page.
|
|
|
Post by dreamboatcruise on Jan 11, 2018 14:12:10 GMT -5
From what I hear, Wikipedia looks at the credentials of person(s) making a submittal. Perhaps you could forward your suggestion to the VDEX staff? One or more of the doctors there might take on the task. No, anyone can write and edit articles. That's the whole point of a wiki. See Who writes WikipediaThough when I tried editing a topic years ago, I discovered the block of IP addresses I was in with my ISP were blocked... presumably because of some prior abuse from a user in my general locale. Hopefully they've improved that mechanism so that they don't discourage motivated people with pertinent knowledge from contributing.
|
|
|
Post by dreamboatcruise on Jan 11, 2018 13:45:41 GMT -5
To your point. it was not possible to make insulin that performed identically to that produced by the pancreas, because the delivery was subcuteneous rather than into the blood stream. How's that? Isnt injected insulin an acidified hexamer insulin, to slow breakdown in the blood which would be too quick, ie its not the same chemical as the active form of insulin in the body whereas Afrezza is monomeric insulin contained within the Technosphere coating ie same type of insulin as the active form in the body? By contrast I think the body does produce a type of hexamer insulin but that is as part of storage and synthesis, not active use. So one can I suppose say hexamer insulin is 'natural' but its just not the right stuff if you want active sugar response, rather it is a chemical precursor of active insulin. With afrezza one directly uses the active natural version of insulin without the middleman. But Im no biochemist. Im not much of an investor either, now I think about it... I expect someone here can say it better. I think Im making similar point to Peppy. I wrote a very long response getting into details, hit send and got an error... and the post was lost Short answer. There are different types of injected insulin, for the most part they are engineered to shift the balance of monomers vs hexamers vs even larger groups of multiple hexamers. The larger they are the longer it takes to migrate through fat and cross capillary walls. It isn't an issue of what happens once in the bloodstream. The pancreas does release insulin into blood in hexamer form and it disassociates rapidly into monomers, so the time differences are about how long it takes to get the insulin into the blood. Capillaries in pancreas are more permeable to the large hex insulin than capillaries elsewhere in body. Taking insulin solutions meant to be used subq and injecting them into muscle or intravenous will result in faster kinetics... with IV basically behaving similar to Afrezza. I believe that would even be true of long and ultra-long acting insulins though I'm not 100% positive on that. agedhippie ... agree that Afrezza is far from replicating the complex and reactive behavior of Pancreas (and the fact of where in circulatory system it releases insulin). Doctors who presumably know the physiology would be less impressed by the claim of "Pancreas like" behavior, but it appears that association does have some resonance with many patients even if the truth is the more complicated "replacing the first phase insulin response in a way closer to the pancreas' own response better than any other insulin other than when injected IV". Didn't see your post until I had already created mine. Yours is even more succinct.
|
|
|
Post by dreamboatcruise on Jan 10, 2018 17:51:01 GMT -5
My understanding of HIPAA is that the data could not be sent to third party even with identity stripped unless consent is given. There are real concerns about the ability to identify individuals even when their nominal identity (name or social security number) has been stripped. Onduo, which is a spin off of Verily, is one of those companies that provides app and remote coaching. When one consents to use Onduo they are likely consenting to Onduo using the data for analysis and coaching purposes. Though still, that doesn't give Onduo right to share/sell data... likely not even sharing with Sanofi or Verily (its owners). I consider that a relative non issue, what's the difference between that and the standard form the patient signs when they check in for the first time giving consent for the physician to share lab results etc., with any referring physicians, etc...I would venture to say that most patients sign those forms without even reading past the first paragraph. The suggestion had been made that there is an agreement whereby Google/verily will monetize personal health metric readings collected from Dexcom meters and pay Dexcom up $1B or more for that data. That is very different than signing a form that says info can be sent to another personal care physician... and current practice is that you sign consent on the other end as well, giving the specialist approval to request your info (if it's not a referral from the first). If a doctor were to slip in language in those forms, that no one reads, stating that they could sell your medical record data, would you not mind? do you think that would fly as legal under HIPAA? I would think that if a doctor had health practice legal representation, the attorney would be jumping up and down screaming if that was proposed. I would also think that an attorney would scream at Dexcom if they suggested slipping in a clause into the "no one reads" fine print that they have the right to sell all your CGM data. I think some people assume that the biggest barrier to utilizing the wealth of electronic health data that already exists is a technology problem, whereas it mostly is a patient privacy issue. I did some consulting for a company a number of years ago that was developing a way of creating anonymized medical databases that could be queried and yet prevent (or greatly complicate) using the data that is there to figure out patient identity, so I'm a little bit aware of HIPAA privacy issues despite not having actually worked in healthcare field.
|
|