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Post by dreamboatcruise on Jan 15, 2018 14:24:49 GMT -5
Sports, your prefacing of the cafepharma article is on point! As anyone can write anything on there with no accountability. For that reason, I generally take most of what is posted on that site with less than a grain of salt. But that's just me! However, Doctorgreenback raises some very valid points. Number one being that nothing works better at controlling BG spikes and "nothing is more convenient than Afrezza" MNKD needs to be putting Afrezza in place to be the "go to" insulin for patients using the CGM. If they are not working on that or inking a deal as I type, I will be surprised!If MNKD misses this opportunity, it could be a fatal misstep/mistake. Hopefully, we hear something big from management either this month or soon after addressing this. IMHO, This is paramount! Decisions about what insulin to use are made by individual physicians. There is no way to strike a deal that would make any insulin a "go to" insulin for CGMs, as it requires education to convince large numbers of doctors.
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Post by dreamboatcruise on Jan 15, 2018 14:03:52 GMT -5
Peppy, I love you BUT why do you think Insurance Companies want to or will pay $1,600 per month when injected insulin is much cheaper? ? They don't. They won't. Afrezza is so far overpriced it's ridiculous. Cut the price of Afrezza SIGNIFICANTLY BELOW injected insulin and increase its Sales by three, four, five times or more! Make insurance companies our friends... by making Afrezza CHEAPER than Humalog and Novalog. Why do you think if this is the case that they haven’t done it? I talked to a rep who said the only thing that’ll help insurance is more patient demand. Then I talked to a real smart person over the weekend and he said the only thing that will help is the person they hired to do the negotiations with the insurance company’s. Really three different theory’s. Has anyone ever asked Mike? or has Mike ever talked about it? It makes sense that lowering the price would help, but I have no experience in this field at all. Has that worked before with other drugs? Before the label change Mike stated something about not preemptively lowering price because the label change should enable better pricing... or something very similar to that. At the time they were presenting different possibilities for the label change including a different adjective/classification, which we did not get. To my knowledge there has been nothing said after the label change to indicate what effect the label as approved would have on pricing strategy.
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Post by dreamboatcruise on Jan 15, 2018 13:56:46 GMT -5
Indices are a double edged sword. FWIW, E*trade recently told me that MNKD was not in demand for shorting from their loan program. IB, Fidelity, and Schwab seem to disagree. Schwab has returned all of my shares for the first time in the three years I've been in the loan program, so no disagreement there.
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Post by dreamboatcruise on Jan 14, 2018 15:03:22 GMT -5
Shorting MannKind means you do not want to try to help make the world a better place. You are shorting hope. That's what the shorts have been counting on... that they are shorting nothing but hope. Hopefully they will at some point be proven wrong.
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Post by dreamboatcruise on Jan 14, 2018 14:20:57 GMT -5
sayhey24... even in engineering trials are often used. The military has several large field trial programs for various types of equipment. They are deemed important to show whether real world soldiers can easily use the equipment, whether the equipment holds up to real world soldiers in a field situation and whether the new stuff integrates well with older equipment in real world scenarios. Not to mention that a lot of consumer gear (and software) goes through various stages of trials including often fairly large "beta testing" trials where a broad user population is involved. In medicine we are not even close to having a physiological model of humans that can take the place of trials. The body is simply too complicated and interactions too numerous. The medical research field (and FDA) are only at the very beginning of accepting modeling as a valid adjunct to trials, but certainly not replacing them.
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Post by dreamboatcruise on Jan 14, 2018 0:04:33 GMT -5
I wanted to jump in with some real world feedback on the issue of script writing. Don't mean to be a downer, just giving info that board members might find helpful. We at Vdex interface with a lot of providers and a basic principle we operate under is the more experienced a provider is in the field of diabetes, the LESS likely he/she is to recommend Afrezza. It's obviously not 100%, but the phenomenon is common enough to make the point. In other words, those most "in the know" have soured on the product. I won't get into why that is; most here probably already know. The most common feedback we get from such providers is: "Afrezza's a niche product." "It's too expensive." "Patients aren't that interested." Translation for all of these: the provider doesn't really understand the product. I don't think reps calling on busy docs or TV advertising will turn the ship around quickly, if at all. The product is so different. The conditions of the industry are so unfavorable. The incentives work against providers. This product requires a different sales model. Of course, that's self-serving to say. But, that has been our experience. I hope I'm wrong and scripts take off in the new year. But regardless, we'll be fighting the fight either way. I would certainly be interested in hearing your perspective on the above. Do you think think there is opportunity with PCPs where perhaps they haven't really been aware of Afrezza and thus not "soured"?
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Post by dreamboatcruise on Jan 13, 2018 23:32:27 GMT -5
I thought I heard Mike say it in one of the recent Wharton radio podcasts - of which I think there were 3 installments? I'm afraid I don't have the time to go back and research it. The shorts have sold like 35% "more" of the float short. We know we have to give some part of the pie away cheap this year to fund ourselves to break even. But it won't be the whole short position.. So a lot of them will get burned. The thing I don't get is why some deep pocketed investor doesn't start buying now? Nate says this is the most extreme example of a miss priced asset he's ever seen in his years of investing. Why does it persist? I'm not a black hawk conspiracy kind of guy but I'm starting to seriously wonder... Maybe it's a Black Swan conspiracySeems logic might suggest three reasons... 1) many deep pocketed investors have never heard of MNKD, 2) some may simply not believe in Afrezza and 3) even if they do believe in long term prospects they may not have yet considered the timing to be right. The smart Wall Street money often has much better intel in order to time investments. Us retail investors think we need to stay in for the long run since we never know when something might happen, but the reality is that it's cost us a lot in opportunity cost. I hate to think of the returns I've missed out on having money in MNKD that could have simply been in an S&P index and generate huge returns over past 5 years. Deep pocketed investors likely have deep pockets because they don't make that sort of mistake.
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Post by dreamboatcruise on Jan 13, 2018 23:16:29 GMT -5
Are you implying that Endocrinologists only get their medication information from pharmaceutical reps and do not do any independent research and/or reading of their own? If they did, then they too would know these things. A clinical trial does not have to be conducted for one to know that Afrezza mimics the first-phase insulin response. The first-phase insulin response and Afrezza's kinetics are both well published and the fact that Afrezza does indeed mimic the endogenous first-phase insulin response is also published. Peak serum insulin concentration is reached in less than 15 minutes with Afrezza, and that is what the natural physiologic time requirement is in order for the first-phase response to successfully occur. A clinical trial for these is not warranted. The facts are already there and published. Do doctors largely get their medical information from reps? Exclusively - no, are they a source - yes. If they aren't we are wasting a lot of money having a sales force. Do they read articles on their own - the ones I know do. Then we get to the assertions you are making. If you want to be taken seriously then you need to have data to back the assertions that is gathered in a clear and transparent way. That is the whole reason for trials, and why the standards of care assign such weight to them. Does Afrezza mimic the first phase response? Superficially it looks like it, but does it really is a question you need scientific evidence to support and a hunch is not good enough. Does the fact that peak serum levels are reached in less than 15 minutes provide a sufficient copy of the first phase response or are there other components beyond the simple release of insulin? Again - trial data to show that Afrezza really does mimic the full first phase response. If you don't produce the data then don't be surprised when assertions are ignored. Not to mention, the pancreas releases insulin into the portal vein which goes directly into the liver. The concentration of insulin is much higher going into the liver than occurs with a comparable amount of insulin entering the general circulation and then going to the liver. Of course if there is still some active beta cells, exogenous insulin would only need act as an adjunct not a full replacement. I agree that many doctors primarily want to see real world trial results vs logical arguments for why something should be beneficial. Tons of new drugs have theoretical mechanisms of beneficial action which don't actually pan out in vivo.
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Post by dreamboatcruise on Jan 13, 2018 17:11:47 GMT -5
Merck aquired SmartCells, Inc. in 2010 to pursue a "smart insulin" or glucose-responsive insulin and they completed a three part clinical trial back in 2016 that involved only 74 participants. No study results have been published since the trial's completion. It obviously was a flunk. Others have developed adhesive "micro-needle" patches that have over 100 needles on them that are suppose to be responsive to blood glucose levels, one in particular uses glucose-sensing enzymes. On the other hand, we have Afrezza which is non-invasive and mimics the endogenous secretion of prandial insulin like that of a healthy, non-diabetic pancreas and restores the first-phase insulin response that is loss in PWD, which also in turn restores glucose homeostasis. Can't get any better than that my friend. 😉 And there you have it Mango! It can't get any better than that! So why is it that BP and the rest of the medical community still fail to see the obvious and apparent benefits of Afrezza? Afrezza should be what every Endo and Diabetic are talking about. And here we sit, under .50 pre split. A brutal beating! Simple... need clinical trial data showing the benefits.
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Post by dreamboatcruise on Jan 13, 2018 12:02:26 GMT -5
Why does Verily need to pay Dexcom? Dexcom becomes a commodity device, along with Libre and the rest. The meters would send directly to the Verily "Cloud Service" just like you can do with Nighscout today. Remember Google brought $250M of in-kind technical capability Verily deal. Some "Cloud" stuff and some predictive algorithms (which are IMO pretty much useless with afrezza). You sign up for the Verily service. Its your decision if you want your doctor to be able to access your data but Verily wants to be the primary diabetes doctor and coach through their Teledoc service. Verily cuts the deals with insurance companies and as a PWD I have the option to allow reporting to the insurance company for the "pay for performance" discounts. Just like the dongle Liberty Mutual and Progressive give out if you want a discount on your car insurance.Pay for performance is coming very fast now that we have the CGMs and Cloud in place. Diabetes is a huge health cost and if the insurance companies can keep you healthy to 65 then they can off load you to Medicare and at that point they don't care what you die from. However if they can stop the heart attack at 60 and all the health costs prior its a HUGE win for them. However, monitoring is not good enough. They need to address the root cause which is the after meal BG spike. For clarification... do you have a source of information that they are doing these things including pay for performance discounts, or is that what you imagine/hope they will do? It isn't always clear in your posts what you are trying to convey. I've discussed these cost dynamics with a friend that is a finance exec with a healthcare system. Sadly, as I've stated, they don't take the long term view of things. They aren't asking what will prevent the heart attack at 60 when someone is 50. The bonuses for management are based on this years profits. It would be nice to think that everyone in our healthcare system was concerned about providing the best healthcare possible, but that all too often takes a back seat to short term profitability.
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Post by dreamboatcruise on Jan 12, 2018 18:25:54 GMT -5
Personally I will be happy with either the note 1.) being pushed back for another quarter, or 2.) Mnkd paying the $10m. Obviously if the note is pushed back, then no harm/no foul. If mnkd pays the $10m, while shorts may see this as a lack of confidence by Deerfield and therefore say it is a negative event, I see it as a positive event and sign of strength by mnkd that they believe they are on the right path moving forward and have hence refused to lower the price and renegotiate the buy-out terms (which is the third and least favorable option in my opinion.) Paying Deerfield the $10m really should be no burden on cash as mnkd is mostly out of cash regardless by end of March or so and they can just add another $10m to the cash raise we all know is coming. GLTAL's!!!! Agree with the first portion, though it certainly has an impact on cash flow and pulls forward the time when financing would need to occur and right now the market isn't in a very receptive mood towards MNKD. But if management chooses that route (assuming that Deerfield would be willing to take discount shares, which I don't see why they wouldn't) it would seem to mean they feel our share price will be in better shape even within a shortened window due to the cash draw down.
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Post by dreamboatcruise on Jan 12, 2018 18:16:21 GMT -5
Yes DBC, I have read about it. Believe it is called "Smart Insulin." I remember reading about it in the past. Think it involves nano technology but have not seen much about it in last year or so. In general if researchers are throwing around the term "nano technology" for a drug product, I tend to think it may be more hype than reality. Many drugs, even very old ones are within the size range of "nano technology". I'm assuming the "smart insulins" being pursued aren't using technology outside the realm of normal molecular biochemistry. Perhaps they are doing something in a very different way than normal drug development, but I'm skeptical. I've learned to look twice at any investment that claims to be nano tech based.
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Post by dreamboatcruise on Jan 12, 2018 17:58:47 GMT -5
What we do know is the Novo Scientists are on the record saying they have no way to improve on Tresiba. In other words, future basal improvements are not in anyone's near-term pipeline. For prandial nothing is better than the pancreas and no exogenous insulin can ever do a better job than afrezza. In other words, future prandial developments are not coming either. It was obvious at ADA 2016 nothing was coming, more obvious last year and this year the focus will be CGMs, the cloud and monitoring. The elephant in the room is after monitoring you need to address the problem and the problem is post meal BG spikes. Nothing deals with that better than a healthy pancreas or afrezza. There are researchers trying to develop a BG activated insulin. You might not call it prandial since it would be something that would likely not be dosed with each meal, but if feasible it could replace prandial and basal. I have no real insight into when or even if that could come to reality, other than know it isn't soon.
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Post by dreamboatcruise on Jan 12, 2018 17:38:01 GMT -5
Dexcom annouced at the J.P. Morgan Healthcare Conference a new relationship with United Healthcare and will be starting Type 2 programs. The G6 (no calibration) will be rolling out later this year ~ mid year/2H. Dexcom will be heavily focused on the Type 2 market going forward. The analytics will be completely different for T2D. Dexcom and Verily will launch their first product in 2019 and will be a limited run. The second launch with Verily is their main focus and is expected to launch in 2020. Will be disposable, small and discreet, no calibration, fully loaded and ready to connect to any smart device via bluetooth, etc. Dexcom CEO said he expects/anticpates the company to launch more in the next few years than the past 15 combined. I wonder if the Onduo launch will follow the G6 launch? I see little reason for a T2 not on insulin to be using a CGM. Any idea whats incorporated when they say analytics? Onduo is launching before then. According to recent press release... "Pilots will begin in the first quarter of 2018 in Arkansas, Georgia and South Carolina with select Blue Cross and Blue Shield (BCBS) members who are eligible." Linvongo seems to be a bit ahead of Onduo. They've partnered with the same company as Onduo for insulin dosing recommendation software (Voluntis Insulia) which I think is already in use with patients via Livongo. BTW... Insulia got its FDA approval in Dec 2016.
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Post by dreamboatcruise on Jan 12, 2018 17:22:31 GMT -5
Real time is all very well but you should see what running a Dexcom G5 in real time mode does to your phones battery life! That is not even in real time but at 5 minute intervals. That sounds like they have some major glitch/bug in their software... or a problem with your particular phone's bluetooth. It is bluetooth used to connect phone to Dexcom, isn't it? From a technical standpoint there is no reason that collecting data once every 5 minutes should be a significant drain on battery.
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