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Post by casualinvestor on Mar 23, 2018 9:32:06 GMT -5
Mike keeps saying "promotionally responsive" but pointing towards doctors and reps does not make sense to me. Who would stop prescribing a medication after witnessing it works better for their patients because a rep did not visit them for a few weeks and why? Are they waiting for a free lunch? Is MNKD going to waist another year before realizing that it's patients that will drive sales, not sales reps? ——————- You know I agree with that, but I don’t agree with the first part of the post because I’ve met too many people, and I know too many people, that have asked their doctors and the doctors don’t have a clue. Or they think it was the bong. Just ask Hillard:-) The latest presentation said that Afrezza was extremely promotionally sensitive. Because of that we might think: "Why are we not promoting then!?" As cash poor as MNKD is, they may be waiting for a better moment to promote. Because they can't afford a wide reaching, long-term promotion. That moment may be around the STAT study release. It may be after the cash program goes live...and that will ?probably? wait until the OneDrop A-One study finishes (Estimated Primary Completion Date : September 30, 2018). It may be something else. Afrezza may have a quiet spring. TrepT and Dronobinol powder also look long term |
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Post by agedhippie on Mar 23, 2018 9:39:20 GMT -5
Here's a simpler way of explaining the positive outlook. Dr. Kendall, being the former chief scientist with the American Diabetes Association and Vice President for Lilly's global diabetes organization, likely knows more about the science of diabetes and the diabetes industry than anyone alive today. Al Mann with his 180 I.Q. would have been an exception. IMO, Dr. Kendall's recent peer review of the company and Afrezza trumps all other perspectives including mine thus the enthusiasm. That might be better phrased as VP Global Medical Affairs in the diabetes division. Each division has it's own VP for this role. It is not a clinical role, but rather it is operational. Medical Affairs handles the strategic part of launches (timing, sequencing, PR, countries, etc.) as well as voice of the customer (VoC). If you want the diabetes expert at Lilly that would be Dr Kendell's peer, Ruth Gimeno who is VP - Diabetes Research and Clinical Investigation. There is no need to inflate Dr Kendell's reputation, at this point his skills on the operations side are far more relevant than the research side. We desperately need a strategic approach selling Afrezza rather than the "throw it at the wall and see if it sticks" approach to date. Dr Kendell should have the experience from Eli Lilly to do just that. From his role at Lilly as VoC he also has the contacts to reach down into organizations and talk the same language - he is a known quantity to the medical world. Does he know more about the science of diabetes than anyone alive today? Not even close. Does he know more about the diabetes industry? Now there we may be getting somewhere, and this is far more important. |
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Post by akemp3000 on Mar 23, 2018 9:53:55 GMT -5
"...they may be waiting for a better moment to promote." I agree and believe this could be exactly what's happening. Mike has one international term sheet signed whereby they're finalizing the agreement details before announcing in Q2. A second term sheet is also progressing. Both are expected to provided upfront and milestone payments though probably limited. RLS could provide another milestone payment. Additionally, Mike said months ago that a partner or partners was desired for a larger sales force in the U.S. These possibilities combined with the STAT results becoming public in June might all converge to become that better moment. If the STAT study results are truly going to "shock doctors" showing results that for the first time ever keep diabetic patients in a non-diabetic, healthy pancreas range, it would certainly be an ideal time for promotion.
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Post by mnholdem on Mar 23, 2018 11:27:14 GMT -5
There is also a possibility that STAT and other studies are being submitted to the FDA for another label change. There does not need to be disclosure of submittal and the FDA limits access to submittals, recognizing that confidentiality may be preferred by companies for valid strategic reasons. Once a label change is approved, however, that becomes a material event which must be filed and a PR would be issued.
MannKind appears to be ahead of the pack in conducting studies of key measurements that go "Beyond A1C". They may want to keep their progress quiet for now until they are able to apply it to their marketing, including new TV and internet ads.
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Post by peppy on Mar 23, 2018 11:31:29 GMT -5
There is also a possibility that STAT and other studies are being submitted to the FDA for another label change. There does not need to be disclosure of submittal and the FDA limits access to submittals, recognizing that confidentiality may be preferred by companies for valid strategic reasons. Once a label change is approved, however, that becomes a material event which must be filed and a PR would be issued.
MannKind appears to be ahead of the pack in conducting studies of key measurements that go "Beyond A1C". They may want to keep their progress quiet for now until they are able to apply it to their marketing, including new TV and internet ads.
Agreed. Does MNKD need to wait until after the sponsor releases the study? University of Colorado? clinicaltrials.gov/ct2/show/NCT03143816I think Mike C/Dr. Kendall will tell us on a quarterly conference call when this is done. |
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Post by digger on Mar 23, 2018 11:58:14 GMT -5
There is also a possibility that STAT and other studies are being submitted to the FDA for another label change. There does not need to be disclosure of submittal and the FDA limits access to submittals, recognizing that confidentiality may be preferred by companies for valid strategic reasons. Once a label change is approved, however, that becomes a material event which must be filed and a PR would be issued.
MannKind appears to be ahead of the pack in conducting studies of key measurements that go "Beyond A1C". They may want to keep their progress quiet for now until they are able to apply it to their marketing, including new TV and internet ads.
Mannkind may be ahead of the pack but to what effect for afrezza sales? I still see cost and insurance as the primary problems. Insurers rely on studies using A1c as the measure because they have mountains of statistics showing the correlation between A1c and outcomes. It's already known that time in range correlates with A1c, so what would motivate the insurer to switch from cheap A1c to time in range requiring a CGM? I suspect it would take a very large amount of data showing time in range is superior to A1c at predicting outcomes. For that reason, big pharmas don't do much with time in range since A1c is cheaper and is what the insurance companies use. |
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Post by peppy on Mar 23, 2018 12:23:58 GMT -5
There is also a possibility that STAT and other studies are being submitted to the FDA for another label change. There does not need to be disclosure of submittal and the FDA limits access to submittals, recognizing that confidentiality may be preferred by companies for valid strategic reasons. Once a label change is approved, however, that becomes a material event which must be filed and a PR would be issued.
MannKind appears to be ahead of the pack in conducting studies of key measurements that go "Beyond A1C". They may want to keep their progress quiet for now until they are able to apply it to their marketing, including new TV and internet ads.
Mannkind may be ahead of the pack but to what effect for afrezza sales? I still see cost and insurance as the primary problems. Insurers rely on studies using A1c as the measure because they have mountains of statistics showing the correlation between A1c and outcomes. It's already known that time in range correlates with A1c, so what would motivate the insurer to switch from cheap A1c to time in range requiring a CGM? I suspect it would take a very large amount of data showing time in range is superior to A1c at predicting outcomes. For that reason, big pharmas don't do much with time in range since A1c is cheaper and is what the insurance companies use. Primary Outcome Measures : Improved time in range (70-180 mg/dl) with TI on CGM [ Time Frame: 4 weeks ] Better post-prandial glucose excursion (1-4 hours after meals) with TI [ Time Frame: 4 weeks ] Secondary Outcome Measures : Less glucose variability (GV) (standard deviation and/or coefficient variation) [ Time Frame: 4 weeks ] The area under the curve calculation (AUC) in the PPBG and PPGE, [ Time Frame: 4 weeks ] Change in HbA1c in one-month treatment [ Time Frame: 4 weeks ]above the target time (>180 mg/dl) on CGM [ Time Frame: 4 weeks ] hypoglycemia frequency (below the target <70, <60, <50 mg/dl) on CGM [ Time Frame: 4 weeks ] It's in there. ======================================================================== reports, that after people learn how to use afrezza, with a CGM, the CGM becomes unnecessary. "Cheap" medications and "for profit" the key words of our medical system. ----------------------------------------------------------------------------------------------------------------- hahaha, 500 dollars a month insurance pools for cheap treatments. weehaw. The winners! |
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Post by akemp3000 on Mar 23, 2018 12:32:46 GMT -5
The coming paradigm shift includes the transition from A1c to time-in-range which is relatively new thanks to CGM providers. A very large amount of data will become available quickly from these companies. This will likely be a major subject at the ADA conference in June as A1c is logically an inferior, antiquated measurement when compared to time-in-range. Costs for time-in-range measurements are coming down and won't be a huge barrier due to the fact that current standards of diabetes care based on A1c just aren't working sufficiently. This is supported by the rapid growth of the pandemic. The shift within insurance companies and industry protocols won't happen overnight but it's coming. Better science won't be stopped.
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Post by agedhippie on Mar 23, 2018 13:17:09 GMT -5
There is also a possibility that STAT and other studies are being submitted to the FDA for another label change. There does not need to be disclosure of submittal and the FDA limits access to submittals, recognizing that confidentiality may be preferred by companies for valid strategic reasons. Once a label change is approved, however, that becomes a material event which must be filed and a PR would be issued.
MannKind appears to be ahead of the pack in conducting studies of key measurements that go "Beyond A1C". They may want to keep their progress quiet for now until they are able to apply it to their marketing, including new TV and internet ads.
It may take another trial beyond STAT. STAT was described as a pilot trial which implies there would need to be a full trial. |
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Post by buyitonsale on Mar 23, 2018 13:53:12 GMT -5
Even based on the new label, it should be obvious to the professional that time in range should be improved. It starts working faster = BG levels drop faster = better time in range.
Faster out = less chance of hypoglycemia.
Isn't that enough info to favor Afrezza over others?
Doctors already know it's superior but are not willing to try for other reasons...
They do not need more data, they need a new conscience and a new soul IMO.
I would bet any specialist that has diabetes is using Afrezza instead of any other prandial insulin.
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Post by agedhippie on Mar 23, 2018 14:30:37 GMT -5
Even based on the new label, it should be obvious to the professional that time in range should be improved. It starts working faster = BG levels drop faster = better time in range. Faster out = less chance of hypoglycemia. Isn't that enough info to favor Afrezza over others? Doctors already know it's superior but are not willing to try for other reasons... They do not need more data, they need a new conscience and a new soul IMO. I would bet any specialist that has diabetes is using Afrezza instead of any other prandial insulin. "It seems obvious" is not a basis of medical treatment. Especially when that flies in the face of the best data currently out there - the Phase 3 trial. |
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Post by buyitonsale on Mar 23, 2018 15:43:16 GMT -5
Al Mann cared about patients and wanted to get the drug accepted sooner, jumping through FDA hoops. He was hoping that doctors will embrace it.
I wonder if there were more writers in 2015 when Sanofi launched than there are now... Does anybody know?
If yes, I wonder why... less "data" but more big money behind Afrezza?
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Post by akemp3000 on Mar 23, 2018 16:07:58 GMT -5
buyitonsale: "I would bet any specialist that has diabetes is using Afrezza instead of any other prandial insulin."
Good point for those educated about current prandial options. Regardless of the negativity and challenges of the past, is there a reason other than cost or they didn't know how to use it properly, why anyone would not be using Afrezza?
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Post by buyitonsale on Mar 23, 2018 17:43:50 GMT -5
The road to product adoption lies though those who will benefit the most.
Patients and Insurance companies.
I am reading between the lines of what Mike is telling us:
"we go to health insurers and say every hospitalization for hypo is around $14000"
"the good and bad news is it's promotionally responsive"
"we know it's about the doctor believing and driving the success"
"there is a very large opportunity sitting there in the primary care space"
"doctors don't believe the results"
"the doctors just need to try it. I can't do anything other than say 9 out of 10 docs never even tried the drug"
"that's what it takes is that the patients all have great experiences"
"as doctors see these great experiences play out it will be a self fulfilling prophecy to become the standard of care"
"people all want better health and they all want control"
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Post by agedhippie on Mar 23, 2018 18:14:44 GMT -5
The road to product adoption lies though those who will benefit the most. Patients and Insurance companies. I am reading between the lines of what Mike is telling us: "we go to health insurers and say every hospitalization for hypo is around $14000" "the good and bad news is it's promotionally responsive" "we know it's about the doctor believing and driving the success" "there is a very large opportunity sitting there in the primary care space" "doctors don't believe the results" "the doctors just need to try it. I can't do anything other than say 9 out of 10 docs never even tried the drug" "that's what it takes is that the patients all have great experiences" "as doctors see these great experiences play out it will be a self fulfilling prophecy to become the standard of care" "people all want better health and they all want control" The issue with "...every hospitalization for hypo is around $14000" is that insurers see the numbers and the bills and know this is not a problem. Hospitalization for hypoglycemia is rare because it is easily treated with glucagon by the EMT to the point that in half the call outs the patient refuses to go to hospital after the glucagon shot. When people do reach hospital they are normally just treated in the ER and are discharged (or self-discharge). Where they are hospitalized it is almost always because of a secondary condition and not the hypoglycemia. On top of that the number of ER cases involving hypoglycemia dropped 22% in 5 years between 2006 and 2011. If that rate is maintained this really is not a problem that is going to be keeping insurers up at night. |
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