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Post by akemp3000 on Mar 21, 2018 0:35:52 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
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Post by hellodolly on Mar 21, 2018 5:53:08 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 Thank you for the update. Exciting times ahead. |
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Post by sayhey24 on Mar 21, 2018 6:01:50 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.
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Post by boca1girl on Mar 21, 2018 6:11:05 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. |
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Post by sportsrancho on Mar 21, 2018 6:33:28 GMT -5
From StockTwits......@sunnyholiday
3/21/18, 4:29 AM
@rooksleanne Thank you! And Thank You! to akemp3000 for this great summary! Great relief to see great people at work!
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Post by sayhey24 on Mar 21, 2018 7:11:07 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 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. |
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Post by tw12 on Mar 21, 2018 7:34:30 GMT -5
Akemp:
Bingo! Could not agree more. It's like the moment fifty years ago when I was driving an old, three-on-the-tree Peugeot 403 sedan on vacation with friends in Spain and discovered almost by accident that there was a previously unknown 4th gear (!) if you forced the shifter way up the steering column and that little ole French car settled right into a whole new road-comfy sound and began for the first time purring happily along the highway....
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Post by uvula on Mar 21, 2018 7:37:26 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.
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Post by barnstormer on Mar 21, 2018 7:48:02 GMT -5
I agree Mike's presentation was his best to date. I was disapointed that he has nothing to say about progress with PBMs and insurance coverage in general. It doesn't matter if scrips are written if they can't be filled by the patient. I am glad he is addressing the poor performance of the sales team. It remains to be seen if the decline in scrips can be directly correlated to under performing reps. Every sales team has a few poor performers and top performers should have been able to at least keep scrips stable. The golden rule that 80% of sales is made by 20% of the sales reps worked in my organization for years. Rep turnover is a fact of life. I think Mike was putting a little spin on it. What the declining numbers show is they are having difficulty in adding scrip writers and keeping the ones they have. There should be an exponential increase in scrips based on the doctors they have already aquired. The Rule of 78 indicates what should be expected from the performance of the top reps. Rule of 78. Simply put, the Rule of 78 is a way to quickly estimate a full year’s worth of revenue for businesses that deal with monthly recurring fees (in this case scrips). By applying this rule you can quickly estimate the sales turnover a particular salesperson will bring with a set target every month. www.intelliverse.com/blog/what-is-the-rule-of-78-and-how-does-it-apply-to-sales/If the top reps are consitantly adding scrip writers then the numbers should continue to increase at a predictable rate. There will be those who say that many scrips are written/filled in 90 day increments, but the basic premise is still the same over time. Since the scrips are declining it seems to me they are losing too many scrip writers for whatever reason and until that is fixed Afrezza will continue to struggle. |
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Post by sayhey24 on Mar 21, 2018 7:50:45 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. |
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Post by uvula on Mar 21, 2018 8:02:44 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.
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Post by brotherm1 on Mar 21, 2018 8:12:24 GMT -5
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 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? |
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Post by brotherm1 on Mar 21, 2018 8:23:56 GMT -5
I agree Mike's presentation was his best to date. I was disapointed that he has nothing to say about progress with PBMs and insurance coverage in general. It doesn't matter if scrips are written if they can't be filled by the patient. I am glad he is addressing the poor performance of the sales team. It remains to be seen if the decline in scrips can be directly correlated to under performing reps. Every sales team has a few poor performers and top performers should have been able to at least keep scrips stable. The golden rule that 80% of sales is made by 20% of the sales reps worked in my organization for years. Rep turnover is a fact of life. I think Mike was putting a little spin on it. What the declining numbers show is they are having difficulty in adding scrip writers and keeping the ones they have. There should be an exponential increase in scrips based on the doctors they have already aquired. The Rule of 78 indicates what should be expected from the performance of the top reps. Rule of 78. Simply put, the Rule of 78 is a way to quickly estimate a full year’s worth of revenue for businesses that deal with monthly recurring fees (in this case scrips). By applying this rule you can quickly estimate the sales turnover a particular salesperson will bring with a set target every month. www.intelliverse.com/blog/what-is-the-rule-of-78-and-how-does-it-apply-to-sales/If the top reps are consitantly adding scrip writers then the numbers should continue to increase at a predictable rate. There will be those who say that many scrips are written/filled in 90 day increments, but the basic premise is still the same over time. Since the scrips are declining it seems to me they are losing too many scrip writers for whatever reason and until that is fixed Afrezza will continue to struggle. I thought Mike said the reductuon of vouchers caused the decline in scripts also |
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Post by peppy on Mar 21, 2018 8:38:22 GMT -5
I agree Mike's presentation was his best to date. I was disapointed that he has nothing to say about progress with PBMs and insurance coverage in general. It doesn't matter if scrips are written if they can't be filled by the patient. I am glad he is addressing the poor performance of the sales team. It remains to be seen if the decline in scrips can be directly correlated to under performing reps. Every sales team has a few poor performers and top performers should have been able to at least keep scrips stable. The golden rule that 80% of sales is made by 20% of the sales reps worked in my organization for years. Rep turnover is a fact of life. I think Mike was putting a little spin on it. What the declining numbers show is they are having difficulty in adding scrip writers and keeping the ones they have. There should be an exponential increase in scrips based on the doctors they have already aquired. The Rule of 78 indicates what should be expected from the performance of the top reps. Rule of 78. Simply put, the Rule of 78 is a way to quickly estimate a full year’s worth of revenue for businesses that deal with monthly recurring fees (in this case scrips). By applying this rule you can quickly estimate the sales turnover a particular salesperson will bring with a set target every month. www.intelliverse.com/blog/what-is-the-rule-of-78-and-how-does-it-apply-to-sales/If the top reps are consitantly adding scrip writers then the numbers should continue to increase at a predictable rate. There will be those who say that many scrips are written/filled in 90 day increments, but the basic premise is still the same over time. Since the scrips are declining it seems to me they are losing too many scrip writers for whatever reason and until that is fixed Afrezza will continue to struggle. I thought Mike said the reductuon of vouchers caused the decline in scripts also  |
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Post by sayhey24 on Mar 21, 2018 9:02:15 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. |
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