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Post by Deleted on Nov 10, 2016 14:16:33 GMT -5
Re: naysayers argue that Afrezza is "inferior " It's true Afrezza appears inferior when the dosing is incorrect. I don't understand how at 'this late in the game' Afrezza isn't prescribed at the correct dosages. We are loosing patients and credibility because docs still don't know what they are doing. It sounds like MannKind is taking steps to address this, and CGMs will help, but it's ridiculous that this wasn't addressed at the original Sanofi launch. I doesn't look that complicated... Afrezza is rapid acting, why couldn't it be figured out 90%+ of the time correctly in one doc visit. Example, Doc gives patient snack + Afrezza sample. Doc monitors levels for 30min. Doc concludes 4 units not enough, prescribes 8. Most people could do this without a doc... most people are dumb too... you would need a bit of patience and common sense to be able to titrate. hence all early adopters had so much success
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Post by esstan2001 on Nov 10, 2016 14:26:04 GMT -5
I see vdex as the only catalyst for script sales before mnkd hires more reps in January. Please someone correct me on the following two items if I am mistaken. 1) There is no plan for a trial to prove afrezza causes lower a1c and fewer hypos? The trials are for titration, time in range, and dosing. Also peds approvals. 2) Also, potential rls milestone payments and the 25m sale of the Danbury facility is not included in the runway to 17Q3? These two items represent another means to extend the runway? Thanks. 1. Good question... depends on the sample size of the trial. A1C will certainly be one of hte dependent variables recorded, along with 'real time' blood glucose via CGM; so there is a good chance that this data for dose optimization shows A1C superiority at least when held up against the 171 & 175 trials, and certainly the RT CGM data will be of great value in formulating any new label.
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Post by cjm18 on Nov 10, 2016 14:32:18 GMT -5
I see vdex as the only catalyst for script sales before mnkd hires more reps in January. Please someone correct me on the following two items if I am mistaken. 1) There is no plan for a trial to prove afrezza causes lower a1c and fewer hypos? The trials are for titration, time in range, and dosing. Also peds approvals. 2) Also, potential rls milestone payments and the 25m sale of the Danbury facility is not included in the runway to 17Q3? These two items represent another means to extend the runway? Thanks. 1. Good question... depends on the sample size of the trial. A1C will certainly be one of hte dependent variables recorded, along with 'real time' blood glucose via CGM; so there is a good chance that this data for dose optimization shows A1C superiority at least when held up against the 171 & 175 trials, and certainly the RT CGM data will be of great value in formulating any new label. Strange the trial is 12-16 weeks. The exact amount of time to impact a1c. Yet conference call didn't mention a1c.
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Post by mannmade on Nov 10, 2016 14:42:30 GMT -5
Agree with most everything. However, looking at the headwinds Afrezza has faced so far, I'd be skeptical that a label of ultra-fast would really make that much difference. If it isn't about lower A1c or lower incidence of hypos, I'd question whether it would really impact prescribing behavior. It's not as if the pk/pd profile isn't out there. If doctors are inclined to see benefit in quick action, they already have the data to understand Afrezza delivers. As for patients, unless MNKD is free to connect the dots and explain in ads that faster can mean better control and less hypos, merely being able to call it ultra-rapid may do little to ignite interest. If they get better labeling regarding the dosing, that could help set the stage for more consistently good patient experiences. I respectfully disagree as depending on the revised label guidelines, the use of "Ultra Rapid Acting" allows for the conversation of no stacking and therefore few if any hypos associated with a lower and healthier Hba1c. And believe me that will sell...
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Post by dreamboatcruise on Nov 10, 2016 14:49:46 GMT -5
Agree with most everything. However, looking at the headwinds Afrezza has faced so far, I'd be skeptical that a label of ultra-fast would really make that much difference. If it isn't about lower A1c or lower incidence of hypos, I'd question whether it would really impact prescribing behavior. It's not as if the pk/pd profile isn't out there. If doctors are inclined to see benefit in quick action, they already have the data to understand Afrezza delivers. As for patients, unless MNKD is free to connect the dots and explain in ads that faster can mean better control and less hypos, merely being able to call it ultra-rapid may do little to ignite interest. If they get better labeling regarding the dosing, that could help set the stage for more consistently good patient experiences. I respectfully disagree as depending on the revised label guidelines, the use of "Ultra Rapid Acting" allows for the conversation of no stacking and therefore few if any hypos associated with a lower and healthier Hba1c. And believe me that will sell... I guess I don't understand why allowing it to be called ultra rapid would change what they can/can't say about Hba1c and hypos. I would think the issue of Hba1c and/or hypos would have to be approved by FDA explicitly. Maybe that is part of the label change they are now discussing. Maybe the new pk/pd data and the new simulated results are enough for MNKD to make these superiority claims.
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Post by mannmade on Nov 10, 2016 15:09:59 GMT -5
I feel some sanity has now returned to the world as Adam F. has published his expected hit piece. Yes, I expected Fartstain to publish something to counter an excellent CC. Right on schedule. Must be Ground Hogs Day or something... Looks like he is coming out of hibernation... Perhaps a good storm will send him back... Whatever, he has lost all credibility as his so called path to BK never materialized...
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Post by cjm18 on Nov 10, 2016 15:11:13 GMT -5
I respectfully disagree as depending on the revised label guidelines, the use of "Ultra Rapid Acting" allows for the conversation of no stacking and therefore few if any hypos associated with a lower and healthier Hba1c. And believe me that will sell... I guess I don't understand why allowing it to be called ultra rapid would change what they can/can't say about Hba1c and hypos. I would think the issue of Hba1c and/or hypos would have to be approved by FDA explicitly. Maybe that is part of the label change they are now discussing. Maybe the new pk/pd data and the new simulated results are enough for MNKD to make these superiority claims. Would another benefit of the ultra fast acting designation be almost guaranteed tier two placement on insurance coverage? Nothing to compete with it.
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Post by zuegirdor on Nov 10, 2016 15:15:54 GMT -5
I respectfully disagree as depending on the revised label guidelines, the use of "Ultra Rapid Acting" allows for the conversation of no stacking and therefore few if any hypos associated with a lower and healthier Hba1c. And believe me that will sell... I guess I don't understand why allowing it to be called ultra rapid would change what they can/can't say about Hba1c and hypos. I would think the issue of Hba1c and/or hypos would have to be approved by FDA explicitly. Maybe that is part of the label change they are now discussing. Maybe the new pk/pd data and the new simulated results are enough for MNKD to make these superiority claims. It takes new diabetics years of 24/7 self care (diabetes by any practical measure is treated in the home, not the clinic)to learn all the tricks and even then its a tough disease to control. the problem is that injected insulins don't work like a pancreas. Afrezza does work like a pancreas. That is what ultra fast acting really means. Once people figure that out it should be easy. But they are afraid. It took them years to have poor control, but control nontheless. The trick is to develop the vocabulary for explaining how to tailor afrezza to your needs such that it is acting like your pancreas. Then it is a matter of a few weeks of trying it out with your diet and lifestyle.
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Post by mannmade on Nov 10, 2016 15:20:23 GMT -5
Yes it may be, especially as benefits of pairing with cgm become more widely known and understood by insurance companies. I have said for quite a long time now that when combined with a cgm (which I think T2's should also have covered by ins) you will have a cure for diabetes without actually curing it and thus drive down much of the long term health care costs associated with the collateral deterioration of prolonged hyperglycemia.
Insurance companies are starting to look at long term benefits instead of just next quarters results. Witness the effort to drive doctors by rewarding them for achieving quality group metrics of success for patient populations. This is a long term effort and not a quarterly short term shift. Also as more hospital groups acquire sole practitioners and small practices and then include then in the treatment of a larger patient population this trend will only grow and technology (such as cgm's) will play an ever growing role and AFREZZAA becomes the perfect partner for this with diabetics. imho...
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Post by dreamboatcruise on Nov 10, 2016 15:25:45 GMT -5
I guess I don't understand why allowing it to be called ultra rapid would change what they can/can't say about Hba1c and hypos. I would think the issue of Hba1c and/or hypos would have to be approved by FDA explicitly. Maybe that is part of the label change they are now discussing. Maybe the new pk/pd data and the new simulated results are enough for MNKD to make these superiority claims. Would another benefit of the ultra fast acting designation be almost guaranteed tier two placement on insurance coverage? Nothing to compete with it. It would be nice to think that, but I suspect that is not the case.
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Post by dreamboatcruise on Nov 10, 2016 15:29:49 GMT -5
I guess I don't understand why allowing it to be called ultra rapid would change what they can/can't say about Hba1c and hypos. I would think the issue of Hba1c and/or hypos would have to be approved by FDA explicitly. Maybe that is part of the label change they are now discussing. Maybe the new pk/pd data and the new simulated results are enough for MNKD to make these superiority claims. It takes new diabetics years of 24/7 self care (diabetes by any practical measure is treated in the home, not the clinic)to learn all the tricks and even then its a tough disease to control. the problem is that injected insulins don't work like a pancreas. Afrezza does work like a pancreas. That is what ultra fast acting really means. Once people figure that out it should be easy. But they are afraid. It took them years to have poor control, but control nontheless. The trick is to develop the vocabulary for explaining how to tailor afrezza to your needs such that it is acting like your pancreas. Then it is a matter of a few weeks of trying it out with your diet and lifestyle. Agree with that... but I was talking about the issue of what they can say/do in marketing... e.g. in a TV ad could they say "may result in lower A1c without risk of severe hypos" or would they be limited to saying "first ultra rapid mealtime insulin" without being able to tell patients why that matters.
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Post by mannmade on Nov 10, 2016 16:05:22 GMT -5
I actually think the trick will be to develop the description of what "Sugar Surfing" is then use graphs and charts/pics as part of the dosing descriptions/instructions. Would make it very simple as follows:
Use AFREZZA in combination with a CGM (now that FDA has approved for dosing) to "Sugar Surf" as follows:
1. Check your cgm before you eat to establish your current blood sugar level 2. If under 150 do not take 3. Start your meal and check your blood sugar 10 minutes after you begin to eat, if your Blood Sugar is at 150 or higher then take a 4u cartridge of AFREZZA to start 4. Check your blood sugar every 10 minutes after you take your first 4u cartridge, and iuf your blood sugar continues to climb or only levels off but does not decline take another 4u cartridge after 20 minutes from taking the first 4 unit cartridge 5. Repeat the above until you have experimented enough with AFREZZA to understand your specific dosing needs.
Dosing needs will vary on the individual and the food/meals choices that are made as well as the quantity of foods but please note there is no need to count carbs as you can now manage your blood sugar with real time dosing and management of you blood sugar.
Now I am not a diabetic, nor do I profess to think it is this simple but on the other hand I thin with a few charts added to the instructions the concept can be conveyed in a much more straight forward way. Especially if accompanied by a link to a video that shows the same process.
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Post by oldfishtowner on Nov 10, 2016 16:49:03 GMT -5
1. Good question... depends on the sample size of the trial. A1C will certainly be one of hte dependent variables recorded, along with 'real time' blood glucose via CGM; so there is a good chance that this data for dose optimization shows A1C superiority at least when held up against the 171 & 175 trials, and certainly the RT CGM data will be of great value in formulating any new label. Strange the trial is 12-16 weeks. The exact amount of time to impact a1c. Yet conference call didn't mention a1c. It's not only the size of the study. There will likely not be a control arm. It is to MNKD's advantage to conduct this study as quickly and cheaply as possible. It's practical importance is to provide guidance for titration and dosing to optimize the patient's outcome, not to prove superiority. Besides, it would make sense to try to optimize titration and dosing before initiating a superiority trial. On the other hand, if time in zone can be controlled for the majority of patients as well as or even close to what Sam Finta et al have been able to achieve, you can bet it will have an impact on scripts and will be reported at the 2017 ADA meeting in the spring.
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Post by victoria on Nov 10, 2016 17:05:08 GMT -5
Agree with most everything. However, looking at the headwinds Afrezza has faced so far, I'd be skeptical that a label of ultra-fast would really make that much difference. If it isn't about lower A1c or lower incidence of hypos, I'd question whether it would really impact prescribing behavior. It's not as if the pk/pd profile isn't out there. If doctors are inclined to see benefit in quick action, they already have the data to understand Afrezza delivers. As for patients, unless MNKD is free to connect the dots and explain in ads that faster can mean better control and less hypos, merely being able to call it ultra-rapid may do little to ignite interest. If they get better labeling regarding the dosing, that could help set the stage for more consistently good patient experiences. I respectfully disagree as depending on the revised label guidelines, the use of "Ultra Rapid Acting" allows for the conversation of no stacking and therefore few if any hypos associated with a lower and healthier Hba1c. And believe me that will sell... (1) I love it that this is a board where people actally say 'I respectfully disagree'. How civilised. (2) I think the designation of ultra rapid would be significant because not only would the drug be 'only in class' but along with it one would have criteria for prescribing which would point doctors towards the drug. Who needs ultra rapid? People who ever have sugar hypers (thanks, cgm technology, until you came along most people didn't think of sugar spikes which cause damage and are commonplace, so that's most patients then) and people who have problems staying in range with so called rapid insulin. So that's a lot of people and no competitor drug in that class. And we are well priced. And no needles. Any marketing needs a USP, and 'ultra rapid' is a great way to start a selling conversation.
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Post by zuegirdor on Nov 10, 2016 17:06:12 GMT -5
Strange the trial is 12-16 weeks. The exact amount of time to impact a1c. Yet conference call didn't mention a1c. It's not only the size of the study. There will likely not be a control arm. It is to MNKD's advantage to conduct this study as quickly and cheaply as possible. It's practical importance is to provide guidance for titration and dosing to optimize the patient's outcome, not to prove superiority. Besides, it would make sense to try to optimize titration and dosing before initiating a superiority trial. On the other hand, if time in zone can be controlled for the majority of patients as well as or even close to what Sam Finta et al have been able to achieve, you can bet it will have an impact on scripts and will be reported at the 2017 ADA meeting in the spring. Superiority is tricky because it depends upon the meal. Trial design needs to avoid bias or at least frame hypotheses in a way that is meaningful to some "standard" expectation of normal nonchalance towards eating. Who cares if Afrezza can equal or best injectable on a low carb (<150 g Carb/day). Part of the Afrezza claim of superioirty is that it works when you can't count carbs like at a restaurant; it doesnt pose a choice between a hypo or spike when you try to cover for a piece of birthday cake with 100 carbs; etc...
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