|
Post by dreamboatcruise on May 11, 2018 15:25:43 GMT -5
Wow, my brother is likely going to attend the meeting. He's been in with me on this investment for years. It's great he is planning on driving up from Orange County. Dave does not mess around. He will be a great addition to us investors and at 6'4, cuts an imposing figure. Lookout below! Get the goods, Does management believe STATs and the hypoglycemia data will move the needle on a.) physicians? b.) Insurance coverage? Any additional label changes? I would suspect they would give a nuanced answer that sounds hopeful but far from implying a certainty. Of course "move the needle" perhaps is a low enough bar they could confidently answer that affirmatively, but some gauges have pretty fine increments to record needle movement. Even MNKD management can't know for sure what will convince independent actors until they actually see results happening. A more pointed question might be asking if they have enough visibility to predict the rate of increase in prescribers or insurance coverage... and if so to share those predictions. Label change would be a good question, though... have you, or do you plan with current data, to submit for any further label change?
|
|
|
Post by dreamboatcruise on May 11, 2018 15:15:18 GMT -5
The Gumps of the world certainly aren't smart enough to understand scientific papers. Too many of the Gumps think they can stumble into success... probably because of that movie (It wasn't real life BTW).
|
|
|
Post by dreamboatcruise on May 11, 2018 15:04:13 GMT -5
Here is my take, Kendall is an ADA man. Chief Scientific Officer at the ADA. Kendall knows well, mealtime insulin is already on the ADA standard of care. So all those type two's that are failing in their triple therapy and should be moved to mealtime insulin, the physician resisting, frankly because of the danger of meal time insulin hypoglycemia. With afrezza, there is a mealtime insulin alternative, both the physician and the patient could buy into, especially with a CGM, which is now paid for by insurance in the USA for the most part.
Medicare yes, but I don't think that is yet true for other insurance for T2s. It should be for all patients needing insulin.
|
|
|
Post by dreamboatcruise on May 11, 2018 14:49:52 GMT -5
DXCM and MNKD both shining today
|
|
|
Post by dreamboatcruise on May 11, 2018 14:31:55 GMT -5
1) I'm curious about these studies showing improved TIR with follow up RAA dosing. Can you provide links to those? I'm actually unaware of many trials that have used CGMs, which is the only way to measure TIR practically other than within a clinical setting for a very small cohort. 2) Even under the current A1c focused regime doctors do consider other metrics such as incidence of hypos and weight gain... and cardiovascular implications of spikes. Some doctors will simply treat to ADA guidelines, but some are certainly smart enough to understand the implications of better weight neutral TIR, which will hopefully be demonstrated by STAT. 3) Sadly, I think you are correct that insurers will not care about TIR. I think you are incorrect in assuming they care about long term A1c. They care about short term profits. Insurers care much about a1c in terms of how it reduces cardiovascular risk in T2. Reducing risk here increases both short and long term profits. Thats why statins are given out like candy. As for A1c vs TIR... there is now beginning to be solid clinical evidence that postprandial spikes are a CV risk factor separate from A1c... read: "TIR does matter". www.endocrinologyadvisor.com/type-2-diabetes/hyperglycemia-in-type-2-diabetes-related-to-heart-disease/article/628385/Surprisingly, however, "beginning" is the operative word. If one googles "diabetes cardiovascular prandial" you can find lots of articles with conflicting results and ones fairly recently before the one cited here saying the evidence that glucose spikes are a separable CV risk is questionable. One limitation is that pre-CGM era looking at PPG spikes was not easy to do for a large trial. There is definitely a need for more studies, however. It would be ideal if MNKD could do big long term CV studies, but they can't. However, if controlling PPG spikes (equivalent to TIR if titration of insulins is adjusted to yield a threshold acceptably low hypo incidence) is shown by other studies to have CV benefits independent of controlling A1c, and MNKD can demonstrate Afrezza offers better PPG control (within acceptable hypo risk) they would have some significant ammo. STAT hopefully does the latter, with the caveat of being a small trial.
|
|
|
Post by dreamboatcruise on May 11, 2018 14:05:29 GMT -5
traderdennis... you're more charitable in your view of insurers than am I.
|
|
|
Post by dreamboatcruise on May 11, 2018 14:00:31 GMT -5
Ever since Dr. Kendall came on board, the use of the term "Standard of care" has become a prominent point that has not been used before. We've talked about it on PB, but I don't recall MNKD using that term aggressively in the past. I don't know if that's due to confidence being built from the STAT study, or something Dr. Kendall has established as MNKD's rallying cry, but it seems to be used frequently now compared to before. Every year the ADA adjusts its standards of care and releases updates -- www.diabetes.org/newsroom/press-releases/2017/american-diabetes-association-2018-release-standards-of-medical-care-in-diabetes.html. Judging from what I read there, getting those adjusted takes some serious work. Especially with the financial might behind the entrenched players benefiting from current standard of care. Regardless of how often they review, it is still going to be a long time to see changes that would meaningfully tilt things in Afrezza's favor.
|
|
|
Post by dreamboatcruise on May 11, 2018 13:18:17 GMT -5
"Again, if I were the physician and saw the difference, I would put my money on the marksman" -- I think Spencer's point is that all the physicians already know the results because similar studies using RAAs have been done in the past. They aren't going to be surprised that checking glucose at 1 and 2 hours after eating and then dosing is going to improve time in range, etc. More important to Mannkind, in my opinion, is that the STAT trial will mean nothing to insurers who couldn't care less about time in range when making tier decisions. Like it or not, they want to see long term improvement in A1c. To get to tier 2, MNKD will have to show afrezza does either a better job or an equivalent job for less money than the other RAAs. 1) I'm curious about these studies showing improved TIR with follow up RAA dosing. Can you provide links to those? I'm actually unaware of many trials that have used CGMs, which is the only way to measure TIR practically other than within a clinical setting for a very small cohort. 2) Even under the current A1c focused regime doctors do consider other metrics such as incidence of hypos and weight gain... and cardiovascular implications of spikes. Some doctors will simply treat to ADA guidelines, but some are certainly smart enough to understand the implications of better weight neutral TIR, which will hopefully be demonstrated by STAT. 3) Sadly, I think you are correct that insurers will not care about TIR. I think you are incorrect in assuming they care about long term A1c. They care about short term profits.
|
|
|
Post by dreamboatcruise on May 11, 2018 13:02:47 GMT -5
Aged, I have been in business over 35yrs. and have learned over that period of time there are some employees/individuals/customers that you just "can't fix" so forgive me if I carried that over but it is the same thought process regarding not just one particular individual but many that fall into the same "arena". Maybe I feel it's stupid to have to respond on another medium because the one that is selectively biased causes me to do so, would you agree that is pretty childish, amateur, and stupid? You are choosing/assuming to apply to one individual, but it is a general statement regarding not just one individual but a whole wrath of ridiculous sentiment that surrounds that situation, ie., stupid/lazy physicians, pharmacies, competing sales reps, you can pick who you want to fall under the label of that which cannot be "fixed" but I am speaking from direct experience of having to deal with same in all the examples I mentioned above. Again, the frustration is more so from a satisfied user of the product that I believe should be in more PWD arsenal towards fighting the disease but isn't because of "stupid" barriers to entry they have been saddled with. I get that you are happy and content to stick yourself, but as Liane pointed out, that is a personal choice/perspective that cannot be assumed that a majority of others share. Wishing you the best, going forward -J SO has no influence over what doctors and insurance companies do. He seems skeptical that they will change. You seem to be having a heated personal debate with him as if convincing him is going to change the stupid behavior of doctors and insurance companies. It is SO you are calling stupid with your title (or at least anyone reading the thread would assume so), not the barriers that he seems to think will be difficult to remove. Most of us longs thought the barriers wouldn't exist at all... most of us thought they'd disappear much sooner. I'm hopeful that things are finally lining up, but I certainly wouldn't call anyone stupid for looking at the past few years and being skeptical about that. MNKD made some missteps, the FDA screwed us, SNY screwed us and that left us perceived as dead and struggling for life in a somewhat broken medical industry. Is someone really evil or stupid just because they might believe the barriers are still real and significant? Obviously there are still many smart people on Wall Street that aren't bought into the risk-reward proposition of MNKD. Maybe you should spend your time trying to convince GS, or the chief strategist of whichever broker you use, of your point of view. If you swayed them it would make a difference. Convincing SO will mean nothing.
|
|
|
Post by dreamboatcruise on May 10, 2018 21:59:53 GMT -5
joeypotsandpans... I'm sometimes unclear what you are writing vs others when things are interspersed, but I'm assuming you are the red text now, correct? It seems like you're projecting that Afrezza sales will be below the lower end of revenue guidance, but possibly pushed over the top by other revenue. It seems you and SO are still within the same ballpark. I certainly wouldn't have the confidence in predicting anything regarding MNKD to want to defend either one of your positions... but I guess from the war of words you both feel you have very accurate predictions worth fighting over. I'll give the benefit of the doubt to management reiterating the lower end of the revenue range given they have far more visibility than I... or you or SO. I wonder if the $2M for India deal gets counted as revenue or will be treated as the SNY upfront was and not recognized when received.
|
|
|
Post by dreamboatcruise on May 10, 2018 20:27:01 GMT -5
Open interest for in the money puts is now down to about 1.7 million shares on the 18th. Only 3300 are in the money for the weeklys tomorrow. What's your interpretation of the meaning of all of this? Does it point towards something actionable?
|
|
|
Post by dreamboatcruise on May 10, 2018 19:46:00 GMT -5
Geez, don't jinx it like that. Life ain't all or nothing.
|
|
|
Post by dreamboatcruise on May 10, 2018 19:26:40 GMT -5
Hope springs eternal. I'll settle for anything that looks like it's on the same growth trend.
|
|
|
Post by dreamboatcruise on May 10, 2018 18:01:18 GMT -5
Aged there is a great amount of responsibility that goes along with managing diabetes correctly, I would rather give the patients the benefit of the doubt/ but it seems you are insinuating there is a certain demographic or class of patients who will not comply ! Should those numbers be build into revenue numbers ... lowering patient population and market share Non compliance is a big issue in diabetes. That's not merely insinuation, it's observed by clinicians and discussed widely. An open question is whether compliance with Afrezza might be better than it is with RAA. Aged seems to think not (reading between the lines). Others believe it might have that potential.
|
|
|
Post by dreamboatcruise on May 10, 2018 17:43:35 GMT -5
We seem to be in strange territory for MNKD. Maybe we'll get more strangeness like a sustained increase in share price
|
|