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Post by dreamboatcruise on Jun 6, 2018 11:45:48 GMT -5
If I purchased shares @ $6 based upon much improved scripts from the label change I wouldn't be happy. While it is possible the STAT study will improve scripts, I don't think it will be dramatic. The STAT study is the only near-term news besides TreT, MannKind will likely hype it up to raise money. As you know I have worried about MannKind's cash crunch for years, I am still worried. I don't think it would take a "dramatic" improvement in scripts to significantly change sentiment. The problem is that management is showing growth in revenue in their charts, which looks good, but it is glaring that NRx has basically been flat for around 8 months (discounting last couple of weeks, but hopeful about their meaning). If we start seeing NRx growing at a steady rate, even if not dramatic, I think it would convince investors to start coming aboard. If NRx is indicating new prescribers coming on board, it would be easy for those that believe in the science of Afrezza to believe the marketing issues are being worked out and growth would accelerate through network effect. But while it appears prescriber base hasn't grown at all over a long period, it is too easy for those that believe in the science to simply feel that the market isn't accepting of the product despite its superiority... the Betamax of the insulin world.
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Post by dreamboatcruise on Jun 6, 2018 11:15:40 GMT -5
Hey ya'll look at that. Significant improvement in fasting blood glucose. That means stress on the pancreas is significantly diminished because glucose homeostasis is being restored. Afrezza has historically improved the fasting blood glucose, and the Affinity 1 clinical trial showed, once again, that Afrezza significantly improved fasting blood glucose. Who wants to be the first to curtail this demonstrable fact? True, but I remember seeing some study that compared using fasting blood glucose as a target metric to A1c and A1c won out. Of course that was not within the context of comparing insulins with different pk/pd profiles (which is a significant point). I believe this is a meaningful piece of data. Most doctors, however, are trained to look at A1c over fasting levels. Increasing use of CGM will open the eyes of SOME doctors as to what is really going on. Hopefully STAT will open some eyes. It will be a process, however, in reaching the masses of doctors.
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Post by dreamboatcruise on Jun 6, 2018 10:58:14 GMT -5
That's a bit Apples and Oranges if you talking about a real change in script trajectory vs management and people on proboards talking about the aspiration of Afrezza becoming a "Standard of Care"... we are currently a blip in side thought as to the standard of care for diabetes in US. It will take a long time and a lot of work to change that. I'm sure you'll be reading here a LOT about SOC, but that is a "tell" only in it is people "telling" themselves their investment will pay off eventually. Hopefully we get some real evidence of a trajectory change and real sustained growth in NRx... or meeting the low end of revenue guidance will start slipping from the grasp of the possible. No inspirational talk of becoming SOC will change that. dreamboatcruise - I agree. I meant talk of Afrezza and SOC outside of our board and outside of MNKD employees. If the medical community starts talking about it--which might start showing up in social media and on-line documentation, then... Well, we just had another story here on proboards of a patient going to a doctor who refused to prescribe Afrezza and cited potential safety issues. So, yes, when we start getting stories of people going to their regular endo and hearing that Afrezza is the standard of care in their practice (or lots of docs tweeting about primarily prescribing Afrezza)... wow, that will be big. Think it's a LONG way off, however. So far this SOC talk is limited ONLY to management and shareholders.
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Post by dreamboatcruise on Jun 6, 2018 10:10:35 GMT -5
Im right there with you. I do have the feeling that things are changing and that we may FINALLY have a return of the pendulum but im not sure if i just want to believe that or if its really happening. There is a big debate right now between my overconfident guts feeling and my cautious scientifically trained brain . gareaudan - It seems that MNKD is at least behaving like THEY believe the pendulum is changing direction. Like many of us, I suspect they're also aware that the rate of change could easily be much more than linear and possibly exponential--think tipping point. One tell could be whether "Afrezza as the Standard of Care" starts getting used more and more in the upcoming weeks post the STAT presentation. That's a bit Apples and Oranges if you talking about a real change in script trajectory vs management and people on proboards talking about the aspiration of Afrezza becoming a "Standard of Care"... we are currently a blip in side thought as to the standard of care for diabetes in US. It will take a long time and a lot of work to change that. I'm sure you'll be reading here a LOT about SOC, but that is a "tell" only in it is people "telling" themselves their investment will pay off eventually. Hopefully we get some real evidence of a trajectory change and real sustained growth in NRx... or meeting the low end of revenue guidance will start slipping from the grasp of the possible. No inspirational talk of becoming SOC will change that.
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Post by dreamboatcruise on Jun 6, 2018 10:03:05 GMT -5
Maybe this should be on a new thread, but what are company plans for immediate post-STAT? Plugging away getting new doctors to start prescribing would be my guess. I believe they hinted at possibility for advertising after ADA, but they really don't have the money to do that in any large way.
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Post by dreamboatcruise on Jun 6, 2018 9:56:53 GMT -5
"Voucher Program – Under the voucher program, potential new patients are given vouchers which they can provide to retailers for a free product. The retailers provide the product to the patient for free and pay the wholesaler for the product, who pays the Company. The retailers submit the vouchers to a program administrator which pays the retailer for the product. The administrator then invoices the Company for the amount of vouchers paid plus a fee. Accordingly, on a net basis, it is not probable that the Company will receive the consideration to which it is entitled for these products. Therefore, the Company excludes such amounts from both gross and net revenue. The cost of product associated with the voucher program is included in cost of goods sold." I don't understand the "accordingly...products" line. What is the consideration to which they are entitled? They say not probable, so does that mean it's possible? How much would it be? What has net basis have to do with it? Thanks. If the retailer didn't submit the voucher then MNKD gets to keep the money. I would say that would be highly unlikely to happen except at the most poorly run mom and pop pharmacies. It's probably all electronic/automated at most pharmacies based on a code rather than actual paper. Though that's why there are so many mail in "rebates" for consumer products, as in that case many consumers are lazy/forgetful and never get around to submitting for the rebate.
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Post by dreamboatcruise on Jun 5, 2018 22:02:21 GMT -5
It’s the same plan my girlfriend had when she worked at Abbott. Wish I worked at Mannkind. I'd certainly jump in if there were an opening for my skill sets. One of the things I've always liked about startups is the shared sense of purpose. Despite in some ways being a more mature company, I think in that regard MNKD is a startup.
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Post by dreamboatcruise on Jun 5, 2018 21:03:57 GMT -5
mango... those are old presentations, correct?
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Post by dreamboatcruise on Jun 5, 2018 21:01:31 GMT -5
From the comments section in the last piece from SO seekingalpha.com/article/4178982-mannkind-afrezza-scripts-stable-enter-final-month-q2 Our old friend Davinci responds to the following question from a commenter: Why would MNKD guide to such lofty numbers, knowing the stock and company will get pummeled in the process. What will be the short term scenario when they announce being short of guidance. ? In his response he (Davinci) basically says that they put the guidance out to essentially dupe investors to buy shares based on the projected guidance and says it keeps their salaries, bonuses, and here's the one I really love ability to add to their resume's , oh yeah, the CEO, CCO, and our illustrious CMO jumped "sinking ships" like AMGN, ALPMY, & LLY to join MNKD just to play charades with people's money to guarantee the aforementioned salaries, bonuses, and add the great MNKD to their resume's....unless of course the last is actually true Wow that Davinci is pure genius, it continues.... Then SO's follows with a response to same question stating that MNKD is between a rock and a hard place in he which alludes to helping drive the share price up in this "short term window of opportunity" heading into the ADA, but then continues with the following ending line.... The STAT study and the hypoglycemia poster presentation at ADA. That could be enough to get another offering completed. That being said, both of these things have their flaws. He believes the studies have their flaws, yes you read this correctly the "hobby writer" is saying he knows more than the good Dr. Kendall himself...you can't make this stuff up. It really makes one wonder if those "bearish" ones that comment to his articles are really as idiotic as they appear or are assuming the general investing public are that naive and gullible to buy into those thesis. Actually you have to wonder about the initial "soft ball pitched" question to begin with. kastanes, I know you continue to read and respect those you talk about "helping you see the light of how wall street works" but seriously how do you negotiate comments like that which make no sense at all considering what they are trying to portray? With regard to STAT he may simply be referring to the fact that it is only a limited pilot study. The good company itself says that. Actually, I would assume that "both these things" is referring to what he speculates is their fund raising strategy... 1) over promise on revenue and 2) take advantage of presumed bump from ADA. I wouldn't take that as him meaning the trials or data/analysis are flawed. But that's just my take based on what you've said of his writing. If indeed he believes the company is consciously over promising on revenue, then I'd agree with him about it being a flawed strategy if that's what he meant. Though personally I do not believe MNKD made a decision to give unrealistic revenue numbers.
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Post by dreamboatcruise on Jun 5, 2018 20:47:24 GMT -5
DBC - here is a public one but I am expecting Dr. Kendall to be releasing info on Al's studies soon.
The CGM used was the Dexcom G4™ Platinum (Dexcom Inc, San Diego, CA).
Results
The median percentage time in range (70-180 mg/dl, YSI BG) during the 5-hour postprandial period with the use of TI was 81.6% (IQ range 72.5-85%, Breakfast 75%, Dinner 93.3%) as compared to percentage time in range without the use of TI 60.0% (IQ range 50.8-75.8%, breakfast 61.6%, dinner 56.6%, P = .059). The median percentage time in range 80-140 mg/dl during the entire study period was 67.5% (IQ range 48.5-73.1%) as compared to percentage time in range without the use of TI of 55.2% (IQ range 52.0-60.1%, P = .032).
Those are pretty GREAT results considering afrezza was up against the AP.
Well yeah, I should have thought of the artificial pancreas study. Of course that had CGM... silly me. That's probably the one I was racking my brains to remember. It was blinded CGM as I remember. I don't think they'll be any other use of CGMs with TI other than this and 162. Most of the MNKD trials were before CGMs where widely available and considered accurate enough to be meaningful in clinical trials.
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Post by dreamboatcruise on Jun 5, 2018 20:32:27 GMT -5
my son, recently 18 and diagnosed with Type 1 8 weeks ago, has a follow up appointment on Tuesday and the nurse mentioned Afrezza without even asking about it. 8 weeks ago the Ped Endo said Afrezza ‘really was just for T2’s’. 😳 I believe we will be walking away with a Rx on Tuesday. Yes, seems like things are moving in the right direction. Didn’t go that well. I was not at my sons appointment today. They wouldn’t prescribe it because ‘they don’t have enough data’ and ‘they need to talk to their director about the safety of Afrezza’. My wife is livid! I’m more just appalled that docs have no clue. An Endo!!!! She said ‘well do you think 4 units is too much?’ My wife said ‘not equivalent units to novolog’. Doc said ‘insulin is a growth hormone and who knows what could happen to the lungs’. My wife said ‘REMs were lifted last month, launched 4 years ago’. Wouldn’t prescribe it and wouldn’t give a timeframe. We are reaching out to other docs in the area listed on Afrezza.com website. It will happen but will take longer than I wanted as he is going to college in august and preferred to have him get used to it at home. Blows my mind that an Endo is that ignorant about a 4 year old treatment. Regardless how much money mnkd has for advertising or education, endo’s should know more than they do currently. There is a lot of data available about MNKD going above and beyond on lung safety... and of course the adverse events database. Citing REMS isn't very convincing as that was merely an assessment that the risks had been properly communicated, not that the FDA had changed its position on the magnitude of those risks. Sorry to hear the outcome. It is frustrating. MNKD has beefed up the Medical Affairs team and being available to talk to said "director" is an important part of their job. Hopefully that process starts happening.
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Post by dreamboatcruise on Jun 5, 2018 20:19:32 GMT -5
"such individual is actually providing services to the Company as an employee, consultant and/or Director" Not limited to executives/directors. 4. ELIGIBILITY. Section 16 Insiders shall be eligible to participate in the Plan. 12 (r) “Section 16 Insider” means any Director, and any individual designated by the Board of Directors of the Company as an officer of the Company for purposes of Section 16 of the Exchange Act. I hadn't at first noted that (Thanks Boca). Given that, I think the real purpose is to provide a plan for regular purchases by insiders that gets around insider trading issues. Assuming there are actually a number of these Section 16 Insiders wishing to participate (and the number of shares is a meaningful amount of those made available), that is a quite positive thing. We just don't yet know how many are interested or how large the purchases will be.
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Post by dreamboatcruise on Jun 5, 2018 20:10:44 GMT -5
I wonder if this, although not a large pool of shares, sets a "floor" on MNKD stock? By doing this, management is sending a message that they are expecting the share price to climb from here on out. Why do this if the company's stock continues to drop and it is cheaper to buy on the open market? This is just my rambling. But, recent activity from management and rx trends would suggest that our suffering from years of constant headwinds might be coming to a close. And the new era that we have been waiting for for SO LONG is finally starting to take shape. Can you feel that? Yup that's right. A warm summer breeze on your back. Still buying weekly. This document doesn't actually reveal that anyone is electing to do this. So it's ability at this point to boost sentiment is probably limited. Likely that benefit might come if/when the SEC is notified of individuals taking advantage of this plan with purchases. Certainly if a number of execs are buying concurrently, that could peak interest. I know some investors who routinely look at insider purchase reports at least as a screener for stock to take a deeper look at.
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Post by dreamboatcruise on Jun 5, 2018 19:42:49 GMT -5
Mango - awesome work, congratulations on moving the ball forward. I will say I am having a real hard time following the discussion with Aged. My understanding of the poster is it was put together from the lost studies and to answer another discussion, yes there have been studies done in the past with TI and CGMS.
Is it 162 you're talking about? That one does mention CGM to measure BG excursions and variability, but on FDA site it says that analysis was not done due to early termination of the trial. I guess we'll not know what's up with that hypo poster until the ADA session. There are multiple possibilities and we have been given no info from management about where the data came from or what sort of "adjusted" analysis might have been applied.
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Post by dreamboatcruise on Jun 5, 2018 18:50:02 GMT -5
Here you go The starting HbA1c is 7.98% for Afrezza and 7.88% for Novolog. Over the 24 weeks of the trial the Afrezza HbA1c dropped by 0.21% to 7.77% and the Novolog dropped by 0.40% to 7.48%. That make 0.21/7.98 = 0.0263 or 2.63% drop vs. 0.40/7.88 = 0.0508 or 5.08%. The confusion is because HbA1c is measured in percentage of Hb so everything is measured in percentages, both the HbA1c change, and the amount of change. good work. Afrezza. 7.98% - 7.77% = .21 Hba1c which is measured in %. Novolog 7.88% - 7.48% = .40 hbA1c which is measured in %. That is the absolute change aged. statistics, mathematics whatever is applied, the % above is the absolute change. so .21 % of 7.98% = 2.63% is what you are calculating. and .40% of a smaller number 7.88% = 5.08%. These calculations are made to baffle. let's see what the absolute change is this go around over 4 weeks. I think this exchange demonstrates why in finance a change in interest rate is referred to as basis points. If applied to A1c you'd say it changed by 21 basis points rather than the somewhat open to confusion 0.21%.
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