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Post by peppy on Mar 21, 2018 9:15:37 GMT -5
Sayhey, No one is questioning whether or not Afrezza works. The question is whether or not mnkd can figure out how to sell it. You saying "No one is questioning whether or not Afrezza works" to me is another turning point as "The skeptic in me(you) thinks the lost data none of us have seen is similar to the agreement with RLS". I have spoken with many doctors, most will now say they have heard of afrezza but when you talk with them they have little idea what it really is and its benefits. Part of the problem is the experience level of the sales team and being able to explain why afrezza should be the standard of care for most T2s while contrasting the antiglycemics. Then you have the 171 and 175 studies as the "standard" of information for what afrezza is. Read those and take them at face value and I could make a really good argument afrezza is at best a niche drug. Then look at the insurance coverage and cost and its pretty clear why afrezza has not sold. Throw in the lost years with Sanofi and the fact CGM Cloud technology is now starting to be used and it completes the story. It will only take a few clinical situations like what happened with Hilliard where Mike can now showcase the results that hospital group is now having plus some time, IMO about 2 years. The great news for MNKD is no BP has anything in their pipelines which can compete and MNKD now has Dr. Kendall on the team. Come July with the STAT study we ca show them. We know these physicians are quick studies when given interesting materials.  |
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Post by digger on Mar 21, 2018 10:34:33 GMT -5
You saying "No one is questioning whether or not Afrezza works" to me is another turning point as "The skeptic in me(you) thinks the lost data none of us have seen is similar to the agreement with RLS". I have spoken with many doctors, most will now say they have heard of afrezza but when you talk with them they have little idea what it really is and its benefits. Part of the problem is the experience level of the sales team and being able to explain why afrezza should be the standard of care for most T2s while contrasting the antiglycemics. Then you have the 171 and 175 studies as the "standard" of information for what afrezza is. Read those and take them at face value and I could make a really good argument afrezza is at best a niche drug. Then look at the insurance coverage and cost and its pretty clear why afrezza has not sold. Throw in the lost years with Sanofi and the fact CGM Cloud technology is now starting to be used and it completes the story. It will only take a few clinical situations like what happened with Hilliard where Mike can now showcase the results that hospital group is now having plus some time, IMO about 2 years. The great news for MNKD is no BP has anything in their pipelines which can compete and MNKD now has Dr. Kendall on the team. Come July with the STAT study we ca show them. We know these physicians are quick studies when given interesting materials. It won't matter to insurers whether physicians are quick studies. All that matters to insurers is whatever their actuaries tell them, and if the actuaries aren't using PPGE and those other numbers, then insurers will ignore the STAT results until someone does a study showing PPGE and the other measures represent a better gauge than A1c for assaying risk and establishing premiums. |
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Post by agedhippie on Mar 21, 2018 10:40:09 GMT -5
It won't matter to insurers whether physicians are quick studies. All that matters to insurers is whatever their actuaries tell them, and if the actuaries aren't using PPGE and those other numbers, then insurers will ignore the STAT results until someone does a study showing PPGE and the other measures represent a better gauge than A1c for assaying risk and establishing premiums. A bigger problem is that the majority of large employers self-insure and they know you are going to be out of the door in under 5 years so what do they care about complications compared with keeping costs low now? |
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Post by dreamboatcruise on Mar 21, 2018 10:53:48 GMT -5
IMO, Mike's presentation yesterday at the Oppenheimer Conference was the biggest turning point in a generation for global diabetes care when he confirmed what many of us had hoped and expected; the STAT study ( STudy of insulin Aspart versus Technosphere) results will shock (diabetes) doctors as they have never seen a medicine work like Afrezza. He explained that Dr. Kendall is currently summarizing data from 65 prior Afrezza studies that included 5,000 trial patients which will answer many questions that had not been sufficiently answered previously. The coming release of these studies will make it easier for diabetes doctors to be comfortable prescribing Afrezza, i.e. confirming there should be no concern with lung issues. With this information and the new CGMs (continuous glucose monitors), doctors will now be able to personally witness results in their own diabetes patients as they keep their blood sugar within range of a non-diabetic person with a healthy pancreas. While this is not a cure for diabetes, it's pretty damn close. Mike also explained the recent slow down in scripts, that many non-performing sales reps have recently been replaced with new hires, some coming from Dexcom, and that the Mannkind reps had recently been brought in for additional training. It was good to hear that Mike now expects scripts to begin rising soon. While there's much work to be done, the STAT study results being released at the coming ADA should be the proverbial shot-heard-round-the-world. IMO, yesterday Mike confirmed the coming paradigm shift to Afrezza becoming the standard of care and we now know why Dr. Kendall left a global executive position at Lilly to join Mannkind. GLTA There really was no new information in this presentation vs recent previous ones. I think Mike did a good job of presenting, as many others have said, but presenting old material hardly seems to constitute a turning point. |
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Post by dreamboatcruise on Mar 21, 2018 11:03:12 GMT -5
The skeptic in me thinks the lost data none of us have seen is similar to the agreement with RLS that was worth up to $100M. Standard mnkd playbook. Sales are down because underperforming sales reps were fired but don't worry because this issue was solved. Everything is wonderful now. Really? History would suggest a short time price spike followed by dilution followed by a price crash. I hope I'm wrong. I think you're wrong... IMO, they'll be no short term price spike based on talk of old studies. STAT probably has more potential to peak investor interest. |
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Post by joeypotsandpans on Mar 21, 2018 11:32:01 GMT -5
The skeptic in me thinks the lost data none of us have seen is similar to the agreement with RLS that was worth up to $100M. Standard mnkd playbook. Sales are down because underperforming sales reps were fired but don't worry because this issue was solved. Everything is wonderful now. Really? History would suggest a short time price spike followed by dilution followed by a price crash. I hope I'm wrong. The skeptic in you should have been asking why does a guy as smart as Al Mann invest $1B of his own money? Did he loose his mind or did he really know what he was doing? It was the 118 trial clinicaltrials.gov/ct2/show/NCT00570687 Per the 3Q2009 Quarterly call Al Mann said - I have long argued that AFRESA does not require complex meal titration. Certainly there is no need for carb counting and so forth. The basis of my view was derived from the dose escalation study with meal challenges in which better glucose control was achieved with ever greater doses of AFRESA, yet without any hypos. Yet based on decades of battling these challenges of conventional insulin therapy, some physicians have questioned my suggestion. Therefore, I proposed a meal escalation study in which patients would take a fixed dose of AFRESA and then a series of meal challenges. Our clinical team designed a protocol to set a standard meal with 50 g of carbohydrates. That was the 100% challenge. This was followed by challenges at 200%, 50% and zero percent. When I heard of zero I was shocked. Surely there would be severe hypo. The remarkable thing was that with the regular prescribed dose of AFRESA regardless of carbohydrate intake between zero and 100 grams the range of excursion is only plus or minus 30-35 mg [reduction] from baseline for all of the Type II patients in the study. At the ASDA meeting I described to Dr. [Jay Skyler] the finding that in Type II diabetes with a fixed dose of AFRESA and even with no food there is excellent control without hypo risk. I asked him how that was possible. "Obvious," he responded. He was basing his comments on our recently reported 118 trial in which we showed rapid and virtually complete sensation of [hepatic] glucose relief with AFRESA and the common inability of the remaining endogenous insulin to maintain control, as is the case for a healthy person without diabetes. Indeed, I mentioned this result to a number of KOL's who agree with Jay. So I say to you that AFRESA is what no other insulin has ever done for Type II diabetes. AFRESA restores more physiologic hepatic function, takes a load off the pancreas and avoids the hyperinsulinemia resulting from resistance of other insulins. It better mimics the normal pancreas response. So what does all this mean? First let me say that we will need to follow these findings with much larger trials. If the results of the larger trials support the earlier findings then I state to you that AFRESA should be used very early, certainly after failure with Metformin and as a first sign therapy for a significant portion of patients who are not candidates for Metformin or who do not do well with Metformin. It should be used well before fasting glucose is out of control and as we have seen, AFRESA even leads to lower fasting levels by eliminating the excessive gluconeogenesis. Of course, we will have to repeat some of these findings with specific trials but we have already seen the possibilities for AFRESA as we evaluate the timing of hypos in our already completed trials to date. From what we have seen in our extensive clinical program, AFRESA should benefit the entire progression spectrum of Type II diabetes with a very simple therapy and the experts tell us that it could even stop the progression of the disease. It's one thing to read this and another to be living it  ....currently on vacation in Costa Rica and living it while on the beach, no refrigeration, and carbs a plenty....just catching up on these threads and the oppenheimer presentation...as usual thanks all for the posts and updates. When I return next Wed. have endo appt., rep and her new diabetes educator are supposed to join me at the appt. with endo, looking forward to it. Yes you read correctly, they hired a diabetes educator to work with the sales rep and in liason with the physicians to further help with dosing/titration education between the physicians and patients...IMO this will help tremendously with the retention rates going forward.... One thing I was a bit nervous about was taking the Libre sensor into the ocean, one thing to shower with fresh water another to swim in salt water but came out of ocean and heard the magic beep when the reader caught the signal from sensor...music to my ears .....again living Al's dream, life is good and will be even better after Dr. Kendall presents in June.....as Austin says "yeah baby yeah"!! www.youtube.com/watch?v=JBHKVAs85Kono worries about hypo's keeping me up at night, the only thing keeping me up at night here are those darn howler monkeys that come out in the evening overnight lol... |
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Post by kc on Mar 21, 2018 11:48:43 GMT -5
I for one hope you are right and thank God Mike found the lost studies and had the good sense to ask Dr. Kendall to review. The studies were never “lost”, they just weren’t utilized. What was previous managent thinking, ignoring the treasure trove of data they were sitting on? Hopefully there is enough lung safety data to go back to the FDA and eliminate or reduce the clinical safety trial they require. I think it was lack of a good CMO on board who understood how to analyze and go out to present studies the company has done in the past. I feel the gentle hand of Al Mann reaching from up above and giving them the push. But you also have folks like TCYOD and the JDRF folks including their President who is an Afrezza user. There are many thought leaders that need to step up and make their opinions heard. Dr. Kendall is just the man to get them on the same page. Let's hope that this thread title is correct.
I have used the term on Stocktwits and Twitter for a long time. That Afrezza is a Paradigm shift for diabetes treatment. Glad to see others using it too.
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Post by kc on Mar 21, 2018 11:55:26 GMT -5
I am sticking with "lost". I think it will play better in the movie script. When you get a response of "what studies?" its clear Mike was not aware of all the studies. Why Matt did not sit Mike down 2 years ago and explain all of what had been done, I have no idea. Maybe Matt did not appreciate what Al did. Maybe he did and Mike never opened the box. The importance of the 118 study is huge and sets afrezza apart in diabetes treatment. All is good now and I would be surprised if Dr. Kendall is not already circulating some of Al's findings among his friends. Matt had to be overwhelmed with the passing of Al, getting Afrezza back from SNY, being CEO and CFO... Imagine SNY throwing Afrezza back to MNKD while MNKD being low on cash, heavily in debt, share price having been consequently pummeled, the need for just not a new but for a survival strategy while lacking the financial and management rescources to begin to do so. What did these studies mean to his CFO skills or to our prior CMO who’s strengths I believe were in oncology? no I believe it was more of the FDA LABEL issued that was the problem. That is what the FDA accepted. That has been our struggle. Now its up to Mike and Dr. Kendall to figure out how to use this data from the study in 2009. Al Mann always said that Afrezza was like a remission of diabetes. Need to get Key thought leaders to understand the old studies. They were not based on the current Technosphere device so again there is some relevance to getting acceptance today. |
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Post by kc on Mar 21, 2018 11:59:49 GMT -5
Joey is just living the dream. Life is a Beach and he is enjoying it.
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Post by bill on Mar 21, 2018 12:00:19 GMT -5
It won't matter to insurers whether physicians are quick studies. All that matters to insurers is whatever their actuaries tell them, and if the actuaries aren't using PPGE and those other numbers, then insurers will ignore the STAT results until someone does a study showing PPGE and the other measures represent a better gauge than A1c for assaying risk and establishing premiums. A bigger problem is that the majority of large employers self-insure and they know you are going to be out of the door in under 5 years so what do they care about complications compared with keeping costs low now? Your point may be incorrect since for every person that leaves, someone else arrives--in a thriving business. You're only correct if more PWDs leave using Afrezza (if they cover and someone prescribes) than arrive using Afrezza (from a situation where they were on Afrezza). If the ins and outs balance, then reducing complications does pay off now. |
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Post by akemp3000 on Mar 21, 2018 12:04:42 GMT -5
"It's one thing to read this and another to be living it"...was great to read joeypots! No doubt challenges will remain. IMO, the education of doctors and insurance providers will start moving up rapidly following the release of the STAT study. Whereas Al Mann showed the PK/PD profile graph to everyone he met, the graph Peppy shows in this thread should become the new document that everyone can share once the STAT study shows how Afrezza can enable diabetics to achieve non-diabetic BG results. The lone attempt to downplay Mike's presentation by saying there was nothing new obviously missed the portion where Mike referenced the STAT study results. This was not only new, it was a defining moment in diabetes history that should be chronicled in the eventual movie |
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Post by zuegirdor on Mar 21, 2018 12:48:52 GMT -5
"pique" (sorry)
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Post by dreamboatcruise on Mar 21, 2018 13:13:43 GMT -5
A bigger problem is that the majority of large employers self-insure and they know you are going to be out of the door in under 5 years so what do they care about complications compared with keeping costs low now? Your point may be incorrect since for every person that leaves, someone else arrives--in a thriving business. You're only correct if more PWDs leave using Afrezza (if they cover and someone prescribes) than arrive using Afrezza (from a situation where they were on Afrezza). If the ins and outs balance, then reducing complications does pay off now. The point is it doesn't pay to be one of the few that is extra generous since there would then not be this balance. You'd tend to get more new people that had poorly treated diabetes for which you're now responsible for the complications while sending relatively healthy people out the door. Your paying not only the near term costs of better treatment but also the cost of the poor treatment being offered by your competitors. If everyone in healthcare looked at the overall long term costs it would be great, but they don't. Case in point, look at stories here on proboards of people whose insurance rations the amount of monthly insulin they get or the number of test strips they can use. |
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Post by sayhey24 on Mar 21, 2018 13:15:54 GMT -5
A bigger problem is that the majority of large employers self-insure and they know you are going to be out of the door in under 5 years so what do they care about complications compared with keeping costs low now? Your point may be incorrect since for every person that leaves, someone else arrives--in a thriving business. You're only correct if more PWDs leave using Afrezza (if they cover and someone prescribes) than arrive using Afrezza (from a situation where they were on Afrezza). If the ins and outs balance, then reducing complications does pay off now. I was asked by a self-insured company to help put on an internal employee only diabetes fair. In discussion with them they told me their number one health expense is diabetes. That was not including some diabetes related complicates including heart disease which they had not related to diabetes. It seems employees over 45 tend to hang around awhile and some are not leaving until 70. Thats a pretty long time. When they have health issues and good insurance its tough getting these people out the door. The government says over 8 years for those 45-55 www.bls.gov/news.release/pdf/tenure.pdf But diabetics stay longer. Its the 45 year olds you want to identify early and treat early with afrezza. They aren't going anywhere in five years. I asked them how would they feel if in some cases we could stop the progression and potentially reverse some beta cell damage. The self insured market has the biggest incentive to use afrezza if it can actually stop progression and they can get it for less than $400 a box. 40% of the insurance market is self insured. |
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Post by dreamboatcruise on Mar 21, 2018 13:25:30 GMT -5
"It's one thing to read this and another to be living it"...was great to read joeypots! No doubt challenges will remain. IMO, the education of doctors and insurance providers will start moving up rapidly following the release of the STAT study. Whereas Al Mann showed the PK/PD profile graph to everyone he met, the graph Peppy shows in this thread should become the new document that everyone can share once the STAT study shows how Afrezza can enable diabetics to achieve non-diabetic BG results. The lone attempt to downplay Mike's presentation by saying there was nothing new obviously missed the portion where Mike referenced the STAT study results. This was not only new, it was a defining moment in diabetes history that should be chronicled in the eventual movie We've known about the STAT study for a long time, and based on the titles from the ADA presentation we know that it met it's endpoints. I guess I had way more confidence that they'd be able to show better time in range than you did, because the apparent success of STAT doesn't seem new to me. Mike did throw in some hype/hyperbole as I remember, but good lord hyping things is certainly also not new for MNKD management... they've had an embarrassment of rich hype over years. As I'd expect... not knocking management tooting their own horn at every opportunity. I do hope STAT will make a difference, but there was nothing new in this presentation. I'm very skeptical it alone would be enough to change attitudes at insurers, which are more about short term profitability than patient health. Hopefully it will get noticed at ADA by practitioners. |
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....currently on vacation in Costa Rica and living it while on the beach, no refrigeration, and carbs a plenty....just catching up on these threads and the oppenheimer presentation...as usual thanks all for the posts and updates.
