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Post by sportsrancho on Jul 22, 2018 8:07:38 GMT -5
If compliance with Afrezza is supposed to be so great why was it so awful for STAT? If you are getting a third of a supervised group non-compliant on a trial lasting just four weeks that is bad. Well, you know how it is...you can’t tell every diabetic what to do. (Isn’t that what you wrote in a separate thread?). Right! And like Joey says, of course it’s easier! I can’t even believe we’re having this conversation. Just asking any kid who is now on Afrezza, understands the dosing and can eat what he wants and not worry. It’s a no-brainer. Mike just had to drain the swamp and set the stage for growth and set Dr. Kendall loose:-) I’m thinking we’ll all be happy by Christmas. And a thank you to Nate for his due diligence and steadfastness.
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Post by agedhippie on Jul 22, 2018 8:50:32 GMT -5
If compliance with Afrezza is supposed to be so great why was it so awful for STAT? If you are getting a third of a supervised group non-compliant on a trial lasting just four weeks that is bad. Well, you know how it is...you can’t tell every diabetic what to do. (Isn’t that what you wrote in a separate thread?). Absolutely. You decide what is best for you and follow that. In this case though it's a clinical trial and in order to participate you specifically agree to a whole lot of conditions including a dosing protocol. If you don't want to you don't sign - nobody is forcing you to participate. In this case they knew, but when it came down to it they didn't follow through in large numbers and that is a problem.
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Post by sayhey24 on Jul 22, 2018 8:51:10 GMT -5
The path forward for the success of afrezza and PWDs is straight forward. Update the standard of care for both the T1 ans T2s. Once the standard is updated insurance coverage becomes a non-issue. Will you be able to get an insurance discount if you wear a CGM, maybe. I did the dongle thing with my car insurance and got 15% off. A few less "hard stops" and I would have gotten 20%.
Do all afrezza users need CGMs to use afrezza, clearly not. Affinity-2 demonstrated T2s benefited from afrezza taking a 4u at each meal. Could they have done better, no doubt. The big question for the T2s is under what dosing conditions will a T2 have severe hypoglycemia. In Affinity-2 it was when used in conjunction with TZDs. Dr. Kendall is working the dosing issue now. Winston mentioned the other day using an 8 when he knew he should have taken the 4 and felt some hypoglycemia but in his case nothing a few smarties wouldn't have fixed if he had any but the liver kicked-in.
CGMs in 5 years will be common place. Tim Cook's Apple watchband seems to work good enough for a "fitness" device which is all a T2 or the general public needs. When this happens afrezza will be seen as a general meal time supplement since even the pre-diabetics lose the robust insulin release at meal time which a puff can supplement.
In the short term afrezza needs CGMs to prove to all the "smart people" nothing works like afrezza except a healthy pancreas and they need to update the standard. With the CGMs the "smart people" can no longer hide from the real numbers.
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Post by sayhey24 on Jul 22, 2018 8:55:05 GMT -5
Aged - I thought Dr. Kendall addressed this question "If compliance with Afrezza is supposed to be so great why was it so awful for STAT? If you are getting a third of a supervised group non-compliant on a trial lasting just four weeks that is bad"
He said they didn't believe you could really second dose without getting hypos and they never second dosed at dinner with the fear of lows when sleeping. It sounded reasonable to me.
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Post by agedhippie on Jul 22, 2018 9:04:40 GMT -5
Aged - I thought Dr. Kendall addressed this question "If compliance with Afrezza is supposed to be so great why was it so awful for STAT? If you are getting a third of a supervised group non-compliant on a trial lasting just four weeks that is bad" He said they didn't believe you could really second dose without getting hypos and they never second dosed at dinner with the fear of lows when sleeping. It sounded reasonable to me. Did he really say that? I would love to hear it because he must have gone further. For example the concern about a second dose at dinner is not very plausible because the last correction of the day is literally at bed time. They are all wearing CGMs so it's not like they don't know what is happening. I doubt that concerns about hypos are they problem, I believe the problem will turn out to be that they just forget to take the second dose because they are doing something else at the time. Either way when STAT is repeated on a large scale over a longer period they need to make sure that people stay in compliance because the single dose numbers under-performed RAA for TIR.
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Post by sportsrancho on Jul 22, 2018 9:25:26 GMT -5
Aged - I thought Dr. Kendall addressed this question "If compliance with Afrezza is supposed to be so great why was it so awful for STAT? If you are getting a third of a supervised group non-compliant on a trial lasting just four weeks that is bad" He said they didn't believe you could really second dose without getting hypos and they never second dosed at dinner with the fear of lows when sleeping. It sounded reasonable to me. Did he really say that? I would love to hear it because he must have gone further. For example the concern about a second dose at dinner is not very plausible because the last correction of the day is literally at bed time. They are all wearing CGMs so it's not like they don't know what is happening. I doubt that concerns about hypos are they problem, I believe the problem will turn out to be that they just forget to take the second dose because they are doing something else at the time. Either way when STAT is repeated on a large scale over a longer period they need to make sure that people stay in compliance because the single dose numbers under-performed RAA for TIR. Actually the issue of non-compliance was addressed at the Annual Shareholders Meeting by Dr. Kendall. The patients that were non compliant were so used to the “standard of care” that they did not trust that they would not go into hypoglycemia with a second dose following the first after eating. Read more: mnkd.proboards.com/thread/10248/nate-interview?page=3#ixzz5Lzel7NoNThis is what he said I was there. Although Central has always had a better memory than I do:-)
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Post by cjm18 on Jul 22, 2018 11:13:08 GMT -5
Non compliance was also addressed at the stat study investor conference. It’s worth listening to again. They were afraid of hypos. One slide showed that afrezza was no better at dinner. Dr k theory was fear of hypos in the middle of the night.
As dr k talked to the dosage conversion slide ..I got the impression the first dose was Not high enough.
Also there was mention of a label enabling trial with short duration. And future publishing of trial data tidbits. Looking forward to August earnings call for more info.
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Post by joeypotsandpans on Jul 22, 2018 11:43:54 GMT -5
Aged - I thought Dr. Kendall addressed this question "If compliance with Afrezza is supposed to be so great why was it so awful for STAT? If you are getting a third of a supervised group non-compliant on a trial lasting just four weeks that is bad" He said they didn't believe you could really second dose without getting hypos and they never second dosed at dinner with the fear of lows when sleeping. It sounded reasonable to me. Did he really say that? I would love to hear it because he must have gone further. For example the concern about a second dose at dinner is not very plausible because the last correction of the day is literally at bed time. They are all wearing CGMs so it's not like they don't know what is happening.I doubt that concerns about hypos are they problem, I believe the problem will turn out to be that they just forget to take the second dose because they are doing something else at the time. Either way when STAT is repeated on a large scale over a longer period they need to make sure that people stay in compliance because the single dose numbers under-performed RAA for TIR. I was not going to respond anymore in this thread on this subject but the above paradoxical statement took the cake so just had to ask and give my take on the why's and why not's: (par·a·dox·i·cal ˌperəˈdäksək(ə)l/Submit adjective seemingly absurd or self-contradictory. A paradox is a statement that, despite apparently sound reasoning from true premises, leads to an apparently self-contradictory or logically unacceptable conclusion. source: Wikipedia) WTF? On one hand you are saying they are all wearing CGM's so they absolutely know what is happening, and then go and say that even though they know what is happening they "forget" to take the second dose because they are pre-occupied with something else? ...... unless of course their numbers were doing well enough after the first dose that they weren't alarmed via either no alarm from their CGM of going above their target which of course would be a possible reason/cause they did as you suggest "forget", they were never "alarmed" in the first place. That would be more plausible as they said even the non-compliant numbers were better than the aspart arm. Remember the STAT was designed for T1 only, I would suspect that in general non compliance is light years worse in everyday life in the T2 population and with a Afrezza/CGM (either Libre or Dexcom) combination would improve compliance and in turn improve TIR along with A1c among T2's tremendously when they are educated properly on dosing and follow up dosing. As you have previously stated, T1's are use to the routine sticks out of necessity in the past a whole lot more than T2's that conveniently forget to test their BG levels and certainly opt for non-insulin method of treatment because they don't want to have to stick routinely. There is a reason my A1c dropped 2.9 pts. in a 2.5 mo. period (and subsequent reduction) after I started Afrezza, along with the benefits and superiority of the drug, simultaneously simply much better compliance. When a PWD actually sees the improvement daily in their numbers and feels that much better, it feeds on itself and becomes a self motivator and no brainer to easily stay in compliance especially with regards to T2's who had trouble with either staying compliant previously and or lack of success with previous meds in treating the disease and/or a combination of both. As mentioned previously, Kendall didn't leave LLY to join MNKD because he believed they had a product and technology that was inferior, quite the opposite and anyone that I know who was present at the ASM came away very pleased and optimistic that he joined the company because he sees the bright future with the superior benefits of the product and technology that are the backbone of this company. So bringing this back to original thread topic, I would imagine that Nate sees the same exact thing and thus calls it a strong buy at these levels.
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Post by peppy on Jul 22, 2018 11:57:19 GMT -5
Did he really say that? I would love to hear it because he must have gone further. For example the concern about a second dose at dinner is not very plausible because the last correction of the day is literally at bed time. They are all wearing CGMs so it's not like they don't know what is happening.I doubt that concerns about hypos are they problem, I believe the problem will turn out to be that they just forget to take the second dose because they are doing something else at the time. Either way when STAT is repeated on a large scale over a longer period they need to make sure that people stay in compliance because the single dose numbers under-performed RAA for TIR. I was not going to respond anymore in this thread on this subject but the above paradoxical statement took the cake so just had to ask and give my take on the why's and why not's: (par·a·dox·i·cal ˌperəˈdäksək(ə)l/Submit adjective seemingly absurd or self-contradictory. A paradox is a statement that, despite apparently sound reasoning from true premises, leads to an apparently self-contradictory or logically unacceptable conclusion. source: Wikipedia) WTF? On one hand you are saying they are all wearing CGM's so they absolutely know what is happening, and then go and say that even though they know what is happening they "forget" to take the second dose because they are pre-occupied with something else? ...... unless of course their numbers were doing well enough after the first dose that they weren't alarmed via either no alarm from their CGM of going above their target which of course would be a possible reason/cause they did as you suggest "forget", they were never "alarmed" in the first place. That would be more plausible as they said even the non-compliant numbers were better than the aspart arm. Remember the STAT was designed for T1 only, I would suspect that in general non compliance is light years worse in everyday life in the T2 population and with a Afrezza/CGM (either Libre or Dexcom) combination would improve compliance and in turn improve TIR along with A1c among T2's tremendously when they are educated properly on dosing and follow up dosing. As you have previously stated, T1's are use to the routine sticks out of necessity in the past a whole lot more than T2's that conveniently forget to test their BG levels and certainly opt for non-insulin method of treatment because they don't want to have to stick routinely. There is a reason my A1c dropped 2.9 pts. in a 2.5 mo. period (and subsequent reduction) after I started Afrezza, along with the benefits and superiority of the drug, simultaneously simply much better compliance. When a PWD actually sees the improvement daily in their numbers and feels that much better, it feeds on itself and becomes a self motivator and no brainer to easily stay in compliance especially with regards to T2's who had trouble with either staying compliant previously and or lack of success with previous meds in treating the disease and/or a combination of both. As mentioned previously, Kendall didn't leave LLY to join MNKD because he believed they had a product and technology that was inferior, quite the opposite and anyone that I know who was present at the ASM came away very pleased and optimistic that he joined the company because he sees the bright future with the superior benefits of the product and technology that are the backbone of this company. So bringing this back to original thread topic, I would imagine that Nate sees the same exact thing and thus calls it a strong buy at these levels. In reply to aged; what dr. Kendall said, "Additional dosing decreased/non compliance increased at the evening meal." His thinking is T1's who have been on RAA's prior are increasingly cautious at evening meals secondary to hypo's during the nights sleep. There is a chart on dr. Kendall's presentation in resources depicting the reduced additional dosing at that evening meal. So one other thing. I do not see the STAT as "what ever you labeled it". I have however now witnessed some embrace of every other POC study that hits these board topics. Regarding what Joey saids. He would know.
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Post by agedhippie on Jul 22, 2018 12:29:07 GMT -5
Did he really say that? I would love to hear it because he must have gone further. For example the concern about a second dose at dinner is not very plausible because the last correction of the day is literally at bed time. They are all wearing CGMs so it's not like they don't know what is happening.I doubt that concerns about hypos are they problem, I believe the problem will turn out to be that they just forget to take the second dose because they are doing something else at the time. Either way when STAT is repeated on a large scale over a longer period they need to make sure that people stay in compliance because the single dose numbers under-performed RAA for TIR. WTF? On one hand you are saying they are all wearing CGM's so they absolutely know what is happening, and then go and say that even though they know what is happening they "forget" to take the second dose because they are pre-occupied with something else? ...... unless of course their numbers were doing well enough after the first dose that they weren't alarmed via either no alarm from their CGM of going above their target which of course would be a possible reason/cause they did as you suggest "forget", they were never "alarmed" in the first place. That would be more plausible as they said even the non-compliant numbers were better than the aspart arm. WTF? If they were on target with their CGM there is no need for the second dose and they are compliant. And the non-compliant TIR was far worse than the Novolog arm - 48% to 55% Afrezza to Novolog (slide 69)
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Post by agedhippie on Jul 22, 2018 13:16:39 GMT -5
WTF? On one hand you are saying they are all wearing CGM's so they absolutely know what is happening, and then go and say that even though they know what is happening they "forget" to take the second dose because they are pre-occupied with something else? ...... unless of course their numbers were doing well enough after the first dose that they weren't alarmed via either no alarm from their CGM of going above their target which of course would be a possible reason/cause they did as you suggest "forget", they were never "alarmed" in the first place. That would be more plausible as they said even the non-compliant numbers were better than the aspart arm. WTF? If they were on target with their CGM there is no need for the second dose and they are compliant. And the non-compliant TIR was far worse than the Novolog arm - 48% to 55% Afrezza to Novolog (slide 69) For completeness - the compliant arm was about 62% TIR so the compliant users out-performed the RAA arm by about the same amount that the RAA arm TIR out-performed the non-compliant arm
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Post by morgieporgie on Jul 22, 2018 13:22:36 GMT -5
WTF? If they were on target with their CGM there is no need for the second dose and they are compliant. And the non-compliant TIR was far worse than the Novolog arm - 48% to 55% Afrezza to Novolog (slide 69) For completeness - the compliant arm was about 62% TIR so the compliant users out-performed the RAA arm by about the same amount that the RAA arm TIR out-performed the non-compliant arm So Hippie, do you think the people who don't use CGM technology would fare better with Afrezza or with Humalog? Both used properly, of course.
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Post by agedhippie on Jul 22, 2018 15:38:03 GMT -5
For completeness - the compliant arm was about 62% TIR so the compliant users out-performed the RAA arm by about the same amount that the RAA arm TIR out-performed the non-compliant arm So Hippie, do you think the people who don't use CGM technology would fare better with Afrezza or with Humalog? Both used properly, of course. I think they would do better with Afrezza assuming the Afrezza user is testing at the 90 minute mark following up with a second dose if needed to simulate the second phase release. If you don't do that then you are not using Afrezza properly and it's a more even fight. With a CGM though I can get better TIR than either group of Afrezza users averaged in STAT. That sort of freaked me out because I was expecting the kind of results you see on social media. To be clear, I don't think I can match what you see on social media, but I can hit >80% TIR reliably. A long tail has it's uses. I sometime overdose for a meal because I know that before the tail ends I will have eaten or drunk something that will require insulin. If I load up in advance I don't have to bother to dose again. A CGM is really useful for telling you if that strategy is working.
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Post by sayhey24 on Jul 22, 2018 18:08:29 GMT -5
Aged - at this point I suspect you are about max'ed out on what adjustments you can make. I doubt if you factor out sleeping hours you are beating the compliant group's TIR which if I remember correctly was 100%.
With both the compliant and non-compliant groups their basal can be increased which would not only beat your TIR but also improve their A1c. What was the game changing line from ADA2018 "A1c 8.0 to 6.8 with no additional hypoglycemia".
The reality is afrezza takes less effort and when properly dosed will out-perform all RAAs. Next up should be the pediatric results. What kid wants to stick themselves when they can puff with better control? Once the kids start using its the beginning of the end for the RAAs. I guess Dr. Kendall can also use these results to support updating the standard.
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sky
Lab Rat
Posts: 46
Sentiment: Long
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Post by sky on Jul 22, 2018 19:00:09 GMT -5
Once the pediatrics get approval,the other addaleciants will be puffing on blank dream ⛵
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