|
Post by dreamboatcruise on May 22, 2018 20:08:02 GMT -5
Lets put CGMs in perspective for a moment - about 10% of the Type 1s in the US have a CGM and a lot of them probably aren't using it. CGMs are expensive to run, you are not getting much change out of $5,000 a year if you use it all year so most people who self-fund use it intermittently to keep costs manageable. However if you are using it you know what things look like and move on. It may well make a difference if you now try Afrezza and see the change however what is going to drive the swap to Afrezza? There are new CGMs coming but that is going to take time and are probably not a lot cheaper. Bottom line - do not rely on CGMs to drive sales. All valid points. When I was talking about CGMs coming was as much about their use in clinical trials as long term use by large segment of T2 population (which I feel isn't going to happen soon). I think post prandial excursions, TIR and more standardized reporting of hypos will become more prevalent in trials. FDA really should mandate it for new trials, IMO, even if they blind the CGMs for the patients. I think short term use, as you stated, could be very helpful for many patients. I also think CGMs should be considered standard of care in situations such as assisted living so physicians and responsible family can know what is going on.
|
|
|
Post by dreamboatcruise on May 22, 2018 19:36:36 GMT -5
There are more than one model and a lot of complications, but you're referring to the difference between the health plan organization and the Pharmacy Benefit Manager (PBM). We wen't through a whole wave in the industry where health plan organizations outsourced the pharmacy benefit management to 3rd party companies. Now some health plan insurers are (or considering) bringing it in house again. The model of having independent PBMs certainly did not result in the cost savings they claimed was their raison d'etre. From a consumer standpoint it looks an awful lot like a total scam. dreamboatcruise Your comment is more precise than mine. Afrezza will save insurance companies lots of money by avoiding a whole host of diabetes-related costs, but the 3rd party PBMs who control access to Afrezza don't care because they make their money on drug discounts and rebates. Duh... I'd hadn't realized that most PBMs are third parties that have little incentive to support a drug like Afrezza that saves their insurance company employers money, but doesn't generate any meaningful revenues for them. I'm not sure MNKD can win that battle. Afrezza has nothing to offer PBMs... Sigh... There is one class of payer for which the equation is very different... large employers that are self insured. They actually don't have anybody to easily pass those costs onto. They also have a lot of power to change formularies for their covered employees. However, I think in the past they've relied too much on the PBMs to make decisions for them. I'd encourage anyone that is or knows a patient desiring Afrezza working for a large company to contact HR... they may well be self insured and have the power to demand their PBM add Afrezza, and even if they aren't self insured, it's good to register ones dissatisfaction.
|
|
|
Post by dreamboatcruise on May 22, 2018 19:01:08 GMT -5
The short coming of this article is the "experts" interviewed have no inexperience with afrezza. It would be like going back to 1922 and Banting and Best who are driving a Model T and asking them what they think of a Ferrari 488. Aged got me thinking so I conducted my own "Un-scientific" study today. I asked 20 people their view of insulin and about T2s using it. It was like the Dawn Study results all over again but worse. 100% viewed going on insulin as bad and most viewed it as a failure on the part of the T2. I guess I knew insulin was seen some what negatively but not that bad. Mike is going to need an awesome marketing campaign where insulin is the last word mentioned and its buried on the label in microfont as "active ingredient - human insulin". I suspect more of them than you would guess are aware of Afrezza. Docs are conservative and many view things strictly from the evidence based perspective. There are fairly recent papers looking at the issue of PPG spikes and clinical outcomes that have been less than conclusive. It may be that these knowledge leaders in diabetes are total unaware of Afrezza, but it may also be that they are aware but as yet unconvinced by the small amount of data linking TIR/PPG-excursions to the important clinical outcomes. Now that we have easy access to CGMs I think that situation will change... but I think some of these KOLs are going to require clinical studies not just pretty CGM pictures. Whereas others will get on board quicker. That's what I see in this discussion. Of course hypos is an area where you can see the agreement is strong. As for car analogies (as flawed as most analogies usually are)... back in 1922 one would would have been spot on to have said anyone would be out of their mind to buy such a car to drive on public roads if the specs of a Ferrari 488 were given to them.
|
|
|
Post by dreamboatcruise on May 22, 2018 17:23:23 GMT -5
Hans / that’s thinking big ! I like it 👍 I can think big... AMGN/LLY/MNKD/AAPL/GOOG/AMZN If only I knew more ticker symbols I could think even bigger.
|
|
|
Post by dreamboatcruise on May 22, 2018 17:19:14 GMT -5
Thanks. Sorry MN, missed your thoughts right in front of me. Immediate financial gratification for insurance companies should do it. @scotta @sportsrancho Based on some DMs with Mike C. I've come to understand that there are two halves to the insurance companies. My interpretation of those DMs are that one half handles the fees and payments, and the other handles the drug coverage, pricing, and rebates. It seems the part of the insurance company we want to change is the one that handles drug coverage, but the part where we save the insurance companies money is the half that handles the payments. The two halves have their own profit / loss metrics and our trying to obtain change from the drug coverage half by saving the payments portion money has not worked and may not ever work if that's actually how things work. Instead, our best hope may be to get the Standard of Care changed. When Dr. K starts using words like barbaric in his presentations, folks might actually start to listen. There are more than one model and a lot of complications, but you're referring to the difference between the health plan organization and the Pharmacy Benefit Manager (PBM). We wen't through a whole wave in the industry where health plan organizations outsourced the pharmacy benefit management to 3rd party companies. Now some health plan insurers are (or considering) bringing it in house again. The model of having independent PBMs certainly did not result in the cost savings they claimed was their raison d'etre. From a consumer standpoint it looks an awful lot like a total scam.
|
|
|
Post by dreamboatcruise on May 22, 2018 17:12:58 GMT -5
I expect hedge fund managers to try and drive MNKD down right up to ADA2018 to stay near a good exit point, just in case. It may be a fight, though, as other traders start buying into the rumors. Demand for loaned shares has not returned. I tend to call Schwab's loan dept every week just to get their view... and remind them I've got shares to borrow. It seems like implied volatility dropped quite a bit today.
|
|
|
Post by dreamboatcruise on May 22, 2018 17:07:38 GMT -5
So, in other words, publications should lay it out in laymen's terms - excellent TIR control with statistically significant reduction of severe hypos - and back it up with the scientific detail for those HCPs who are so inclined to dig into the science. One thing I've noticed about seasoned thought leaders, like Dr. Kendall, is that they can simplify complex analysis. I'm sure that the attendees at the ASM noticed that MannKind's CMO has that skill. Can also be a bit of a give and take with other KOL, so that company messaging starts lining up with voices amplifying it. But, absolutely, that is where someone like Dr. Kendall and the Medical Affairs team will earn their keep. There are a lot of different stakeholders that may require different, but consistent, messaging. I do like the fact it seems they are beefing up Medical Affairs. Sales reps can't talk about science that isn't on the label... the Medical Affairs team can. "Healthcare providers can receive evidence-based, scientific responses to their questions about MannKind products by using the link to the left (Healthcare Professionals)."Right now we're early in the process of new era of CGMs with doctors looking at it from different perspectives, as can be seen by all the different views expressed in this article... diatribe.org/cgm-and-time-range-what-do-diabetes-experts-think-about-goals
|
|
|
Post by dreamboatcruise on May 22, 2018 16:24:36 GMT -5
DBC,look at it this way if one is worried about the length of the runway then they shouldn't be on the aircraft, correct? It's all about choices and those making the choice to invest in entry level biotechs should know or be aware of the dilution cycles that come with them, it's generally speaking their only source of fuel to get off the runway . So either most of those on board are confident in the current personnel in the cockpit and the aircraft their on or they're nervous stowaways that are on board for other reasons Setting aside analogies, that are quite possibly one of the worst things to have ever been invented when it comes to business (i.e. you can always come up with some analogy to justify a bad decision). I would not agree with that first statement AT ALL. Whether in management with a company or as an investor, one always needs to be worried about the cash burn and runway... even when profitable in many cases, and ALWAYS when pre profit. I have had too long of a career in and around start up companies to set aside looking at risk and be blinded by potential reward. It is looking at both risk and reward that gives me the confidence to hold my MNKD investment... and also to do things such as utilizing straddle option position about a year ago taking advantage of all time low price even when I thought the risk level significantly higher than it is today. Though, your second sentence implies being aware of financing requirements and dilution is important. If investors should know about dilution cycles as you say... why do you seem to belittle those that raise the issue on a discussion forum, one of whose purposes would seem to be educating people about biotechs, and MNKD in particular, as an investment? I'm invested in MNKD, I'm well aware of dilution cycles (including that MNKD has been way beyond the norm)... and I think the dilution is as much of a valid topic for discussion as how great Dr. Kendall is or dreaming about who is going to acquire MNKD. It was worrying about dilution that I knew was coming that convinced me to earlier in the year sell some May calls I had. Not worrying about that dilution could have resulted in holding onto those calls and they would have expired basically worthless. Pilots worry about the runway... and the amount of weight they have on board... passengers do not. Most investors successful at investing in technology do not view themselves as passengers along for the ride. Index funds are for that. (Caveat: One of my pet peeves in business is watching people get into analogy arguments... as if the original premise of having the analogy was valid)
|
|
|
Post by dreamboatcruise on May 22, 2018 15:40:32 GMT -5
That is one of the reasons for fast uptake through the lung capillaries, but it's a pretty hard story to tell as most people, even doctors, I've spoken to know nothing about polymers or why a hexamer behaves differently in lung vs pancreas vs subq. It seems the company is instead focusing on the other key aspect of speed that it is the large surface area of the lungs that allows such rapid transport. You don't mean that Endos don't understand this? I would hazard a guess that even with endos far from all actually understand the details... such as why the pancreas that stores and releases insulin primarily in hexamer form can match the pk/pd of Afrezza. Or why RAAs, which supposedly prevented formation of hexamers still have pretty slow profiles. I've talked to doctors and pharmacists that had reasonably good grasp on use of insulin that were basically clueless. Most endos I suspect are more into researching clinical results of drugs rather than the details of why a pk/pd profile is what it is. The latter would really only be useful to those trying to formulate new drugs... or those investors looking at the competitive landscape from a scientific standpoint.
|
|
|
Post by dreamboatcruise on May 22, 2018 15:06:17 GMT -5
IMO, nothing will have a more significant impact than Dr. Kendall's new Scientific Advisory Board combined with fresh new articles written by him and published in major medical journals, explaining the simplicity and superior results of Afrezza (STAT). The company has not been able to do this previously. As diabetes industry leaders become aware of and start discussing the results that Mike says, "doctors can't believe", then the ADA, insurance coverage, marketing expansions, scripts and another label improvement will all begin falling into place. I'll let MN edit the countries and or studies, but to your point the first 2 country domino's got flicked (Brazil & India) by MNKD's version of Curry, the study domino is about to get flicked by their version of LeBron, unfortunately the inaugural team was akin to the Raptors (especially after they lost their illustrious owner)...looks good until they get to the playoffs, time to take it to the next level. Kastanes stop worrying about the runway they (the doubters and hecklers) have been preaching the worrying about it for years....thoughts of selling the golden goose off before it starts laying the eggs is why bus drivers will always drive the bus and not own the bus company To be fair to anyone preaching that concern in the past about finances, it now seems we've had confirmation it was warranted... we've just had our CEO come out and make a remark about what dire straights the company had been in. And we've had one heck of a lot of dilution over those years. To you it may not matter whether the stock price collapses while still in a period of needing funding... but having run start up companies myself I guarantee you the owner of the bus company had better not be taking the view you seem to be espousing people should have about the finances. Granted, the leader of an organization needs to be selling a positive vision but that doesn't mean ignoring financial realities. Successful leaders are very rarely Pollyannas. I saw a whole slew of companies in my field go bankrupt in the dotcom bust because of CEOs not paying attention to runway. I did not go under. Perhaps your view is simply, investors don't worry about it that's managements job... fine if that's your thing, but I think very few successful investors (e.g. Buffet) would espouse that.
|
|
|
Post by dreamboatcruise on May 22, 2018 14:30:58 GMT -5
I've written about my views on that several times. I did some digging for the board, probably no more than a week ago, and came up with some papers looking at time in range and at PPG spikes and cardiovascular complications that I think could be important in tying STAT results to improved clinical outcomes. Perhaps you didn't see when I butted in with that.
|
|
|
Post by dreamboatcruise on May 22, 2018 14:18:04 GMT -5
STAT is another step in the right direction linking Afrezza's unique pk/pd to outcomes that matter. There are beginning to be studies looking at TIR and PPG spikes showing preliminary evidence better control of post meal glucose is needed... but that is certainly not "consensus" yet. It will take time.
|
|
|
Post by dreamboatcruise on May 22, 2018 13:48:30 GMT -5
That’s what the word on the street is...I’m hearing second half of the year. ( 2H ) What mnholdem posted right above you is also the word on the street! Of course I cannot remember a time since FDA approval that if polled people here (and on whatever street that is) would not have said revenue were going to take off in a 6 to 9 month period. Is the word on the street that "significant growth" is merely enough to eek out lower end of rev guidance, or something much more dramatic?
|
|
|
Post by dreamboatcruise on May 22, 2018 13:32:21 GMT -5
Once upon a time I remember reading the biggest difference between Afrezza and RAAs besides administration thru inhalation was that Afrezza was monomeric and RAAs were Hexomeric and that had alot to do with the PK/PD am I dilusional or did that just get lost somewhere? That is one of the reasons for fast uptake through the lung capillaries, but it's a pretty hard story to tell as most people, even doctors, I've spoken to know nothing about polymers or why a hexamer behaves differently in lung vs pancreas vs subq. It seems the company is instead focusing on the other key aspect of speed that it is the large surface area of the lungs that allows such rapid transport.
|
|
|
Post by dreamboatcruise on May 21, 2018 12:31:31 GMT -5
Stockholm Syndrome? Give me a break. In the first place I know you’re not one of those people, far from it. But I just met Dr. Kendall. My client and his son got to spend a good amount of time with Mike, and Jake took Afrezza at the shareholder dinner. Along with Joey and Denise. You weren’t there, you didn’t hear what Dr. Kendall said about Afrezza compared to other barbaric insulin's. In addition to that I’m not all that much underwater so I don’t see why it’s so hard to understand. (And I’m very aware Al wanted to sell the company). When you have friends on Afrezza you’re rooting for the company to do well:-) Bottom line is diversification in your portfolio keeps you sane while you’re waiting for the laggards to catch up. I feel good about the company, I feel good about the people that work at the company. I have just as much right to feel good as other people have to feel bad... it’s just my personality to be a diehard. I don’t give up, and from what I can tell nobody at Mannkind is about to give up either! If sports ever gave up I would be absolutely devastated. But I know that will never happen & I'm grateful we're friends. And you're always so respectful, even in this situation. I really should take notes. And for the doubters, Kendall described the preliminary data from the Lost 65 Studies as veins of gold. Who in history has ever described medical data using such profound imagery? Maybe these veins of gold will lead to a sea of gold? "Embarrassment of riches" doesn't count?
|
|