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Post by brentie on Dec 25, 2015 22:20:11 GMT -5
Rick, I remember the video from Sansum about the trial with Afrezza for the artificial pancreas. Afrezza did well. www.youtube.com/watch?v=GGgGjtM5ipgI'm not sure if you remember this so I thought I would throw it out there, Al is not a big fan of the Artificial Pancreas. He thinks there's a better simpler way.... SF: I know you’ve been involved with the artificial pancreas and there’s been a lot of new information coming out, some trials that have proven successful. Do you really think that there is going to be, some day, an artificial pancreas, a machine that will control someone’s life that could go wrong and actually kill someone, possibly? The FDA is probably going to require so many tests and studies to be done. Do you ever think it is a possibility that it could happen? AM: I have to answer that in two ways. First of all, will an artificial pancreas be created that could effectively and safely control glucose levels in diabetes? I believe the answer to that question is “yes.” Do I think that it should be developed, and for the following reason I believe the answer to that question is “probably not.” After introduction of insulin pumps by MiniMed over thirty years ago, and soon afterward also glucose sensors, only 35% of people with type 1 diabetes in the United States are using insulin pumps, even fewer outside the United States, and hardly any type 2s globally. While insulin pumps do provide the best insulin therapy today, they don’t adequately address what I call my three Cs: cost, convenience and complexity. They are too expensive. They are too complicated. They are too inconvenient. I believe that a combination of Afrezza plus a reasonable basal insulin may not provide glucose control quite as good as by an artificial pancreas, the results would not be much poorer and would actually be good enough so that I don’t really see a real business opportunity for such a sophisticated and expensive system as the artificial pancreas. Surely there will likely be some type 1 patients that would use an artificial pancreas but the real need is for therapy that would be much more widely used. www.diabetesincontrol.com/an-exclusive-interview-with-al-mann-founder-and-ceo-mannkind-corp/
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Post by rockstarrick on Dec 25, 2015 23:43:43 GMT -5
Rick, I remember the video from Sansum about the trial with Afrezza for the artificial pancreas. Afrezza did well. www.youtube.com/watch?v=GGgGjtM5ipgI'm not sure if you remember this so I thought I would throw it out there, Al is not a big fan of the Artificial Pancreas. He thinks there's a better simpler way.... SF: I know you’ve been involved with the artificial pancreas and there’s been a lot of new information coming out, some trials that have proven successful. Do you really think that there is going to be, some day, an artificial pancreas, a machine that will control someone’s life that could go wrong and actually kill someone, possibly? The FDA is probably going to require so many tests and studies to be done. Do you ever think it is a possibility that it could happen? AM: I have to answer that in two ways. First of all, will an artificial pancreas be created that could effectively and safely control glucose levels in diabetes? I believe the answer to that question is “yes.” Do I think that it should be developed, and for the following reason I believe the answer to that question is “probably not.” After introduction of insulin pumps by MiniMed over thirty years ago, and soon afterward also glucose sensors, only 35% of people with type 1 diabetes in the United States are using insulin pumps, even fewer outside the United States, and hardly any type 2s globally. While insulin pumps do provide the best insulin therapy today, they don’t adequately address what I call my three Cs: cost, convenience and complexity. They are too expensive. They are too complicated. They are too inconvenient. I believe that a combination of Afrezza plus a reasonable basal insulin may not provide glucose control quite as good as by an artificial pancreas, the results would not be much poorer and would actually be good enough so that I don’t really see a real business opportunity for such a sophisticated and expensive system as the artificial pancreas. Surely there will likely be some type 1 patients that would use an artificial pancreas but the real need is for therapy that would be much more widely used. www.diabetesincontrol.com/an-exclusive-interview-with-al-mann-founder-and-ceo-mannkind-corp/Brentie, I agree 100%, the point of the article, (that I was making), was to show what a big part Afrezza would have played in the success of that system. Its obvious to me that Diabetes and Technology have just teamed up, there are going to be big improvements in noninvasive realtime glucose monitoring, this technology will identify without a doubt, the best mealtime insulin available. Afrezza will have its day in the sun, and its effectiveness will be monitored with the best technology. If it's as good as people are claiming, how can we lose ?? Im a believer !! Merry Christmas
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Post by peppy on Dec 26, 2015 9:34:51 GMT -5
Did I miss anything ?? Isnt this fun !!! Merry Christmas to all Afrezza Safety and Pharmacokinetics Study in Pediatric Patients clinicaltrials.gov/ct2/show/record/NCT02527265?term=afrezza&recr=Open&no_unk=Y Recruitment Information Exclusion criteria: Patients who refuse to follow the continuous glucose monitoring (CGM) guidelines. *CGM's being used in the pediatric trials. screencast.com/t/V4mT3rwgm The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit. Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year.
----------------------------------------------------------------------------------------------------------------- regarding meeting in San Diego:
screencast.com/t/SO7AnwUMvkYG HgA1c: working on dosing with early adapters with Excellent HgA1c changes. screencast.com/t/FCB6F8Sij Indication for Insulin Products and Evidentiary Standard: the applicants must typically demonstrate that the investigational agent offers superior (vs. placebo) or non-inferior (vs. active comparator) HbA1c reduction at ~ 6 months in adequate and well controlled trials (refer to section 14 of the full prescribing information of recently approved insulin products). intensive dose titration for at least 3 months is programmed into the protocols of insulin trials. Adherence to titration recommendations is usually monitored intensely by investigators and applicants in these trials. This design feature helps ensure that a robust, safe, glucose lowering response is elicited from both the new agent and the comparator. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390864.pdf page 6 &7.
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Deleted
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Post by Deleted on Dec 26, 2015 10:22:07 GMT -5
Did I miss anything ?? Isnt this fun !!! Merry Christmas to all Afrezza Safety and Pharmacokinetics Study in Pediatric Patients clinicaltrials.gov/ct2/show/record/NCT02527265?term=afrezza&recr=Open&no_unk=Y Recruitment Information Exclusion criteria: Patients who refuse to follow the continuous glucose monitoring (CGM) guidelines. *CGM's being used in the pediatric trials. screencast.com/t/V4mT3rwgm The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit. Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year.
----------------------------------------------------------------------------------------------------------------- regarding meeting in San Diego:
screencast.com/t/SO7AnwUMvkYG HgA1c: working on dosing with early adapters with Excellent HgA1c changes. screencast.com/t/FCB6F8Sij Indication for Insulin Products and Evidentiary Standard: the applicants must typically demonstrate that the investigational agent offers superior (vs. placebo) or non-inferior (vs. active comparator) HbA1c reduction at ~ 6 months in adequate and well controlled trials (refer to section 14 of the full prescribing information of recently approved insulin products). intensive dose titration for at least 3 months is programmed into the protocols of insulin trials. Adherence to titration recommendations is usually monitored intensely by investigators and applicants in these trials. This design feature helps ensure that a robust, safe, glucose lowering response is elicited from both the new agent and the comparator. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390864.pdf page 6 &7.
this worries me a bit --> the applicants must typically demonstrate that the investigational agent offers superior (vs. placebo) or non-inferior (vs. active comparator) ...
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Post by peppy on Dec 26, 2015 10:32:59 GMT -5
Afrezza Safety and Pharmacokinetics Study in Pediatric Patients clinicaltrials.gov/ct2/show/record/NCT02527265?term=afrezza&recr=Open&no_unk=Y Recruitment Information Exclusion criteria: Patients who refuse to follow the continuous glucose monitoring (CGM) guidelines. *CGM's being used in the pediatric trials. screencast.com/t/V4mT3rwgm The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit. Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year.
----------------------------------------------------------------------------------------------------------------- regarding meeting in San Diego:
screencast.com/t/SO7AnwUMvkYG HgA1c: working on dosing with early adapters with Excellent HgA1c changes. screencast.com/t/FCB6F8Sij Indication for Insulin Products and Evidentiary Standard: the applicants must typically demonstrate that the investigational agent offers superior (vs. placebo) or non-inferior (vs. active comparator) HbA1c reduction at ~ 6 months in adequate and well controlled trials (refer to section 14 of the full prescribing information of recently approved insulin products). intensive dose titration for at least 3 months is programmed into the protocols of insulin trials. Adherence to titration recommendations is usually monitored intensely by investigators and applicants in these trials. This design feature helps ensure that a robust, safe, glucose lowering response is elicited from both the new agent and the comparator. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390864.pdf page 6 &7.
this worries me a bit --> the applicants must typically demonstrate that the investigational agent offers superior (vs. placebo) or non-inferior (vs. active comparator) ...
quote: this worries me a bit --> the applicants must typically demonstrate that the investigational agent offers superior (vs. placebo) or non-inferior (vs. active comparator) ... reply: consider these type ones were on the active comparator prior. screencast.com/t/FCB6F8Sij Matt down under HgA1c 6. down from 6.5 while on apidra and Matt has been able to eat. (already non inferior)
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Deleted
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Post by Deleted on Dec 26, 2015 10:45:10 GMT -5
this worries me a bit --> the applicants must typically demonstrate that the investigational agent offers superior (vs. placebo) or non-inferior (vs. active comparator) ...
quote: this worries me a bit --> the applicants must typically demonstrate that the investigational agent offers superior (vs. placebo) or non-inferior (vs. active comparator) ... reply: consider these type ones were on the active comparator prior. screencast.com/t/FCB6F8Sij Matt down under HgA1c 6. down from 6.5 while on apidra and Matt has been able to eat. (already non inferior)
i think you are not getting my point.. The test will prove superior - label should say superior .. And non inferior means some what superior... but superior says lot more than non inferior.
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Post by mnholdem on Dec 26, 2015 11:41:55 GMT -5
Acquisitions by Google was being discussed a year ago and MannKind was not the only company. A year ago, the editor of Diabetes Mine thought Insulet (formerly chaired by MannKind's new CEO) was a possible M&A target: "But do these changes really make much of a difference for us in living with this illness in the trenches? Probably not, in our day-to-day existence. But then again, future acquisitions or mergers that may be in the works could bring noticeable change for us in our choice of products and access to them. "Meanwhile, what if consumer electronics companies including Samsung, Apple, and Google or even a player like GE decided to gobble up Insulet or Sanofi's diabetes device efforts? Or one of the big glucose monitor players like Bayer, Roche or JnJ that have all talked about potentially selling their diabetes divisions? It's an interesting conversation, and one that may very well be rocking our world soon. "Conventional wisdom says "the only constant is change," and the CEO shifts we've been seeing could very well be a small ripple leading way to much bigger waves in the coming years." Source: www.healthline.com/diabetesmine/the-new-and-old-guard-a-year-of-changing-diabetes-ceosPerhaps MannKind will begin to make some waves in 2016. The BofD recent hired a new Chief Medical Officer Dr. Urbanski who, along with the newly appointed Director Dr. Shannon, has the pharmaceutical-development side of their business model covered. Now they've hired a CEO with a medical-device and disruptive technologies background. We may not see that "tsunami" many were hoping for, but it's beginning to look like a stronger management team is beginning to take shape that could start to make some waves.
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Post by EveningOfTheDay on Dec 26, 2015 23:39:38 GMT -5
Acquisitions by Google was being discussed a year ago and MannKind was not the only company. A year ago, the editor of Diabetes Mine thought Insulet (formerly chaired by MannKind's new CEO) was a possible M&A target: "But do these changes really make much of a difference for us in living with this illness in the trenches? Probably not, in our day-to-day existence. But then again, future acquisitions or mergers that may be in the works could bring noticeable change for us in our choice of products and access to them. "Meanwhile, what if consumer electronics companies including Samsung, Apple, and Google or even a player like GE decided to gobble up Insulet or Sanofi's diabetes device efforts? Or one of the big glucose monitor players like Bayer, Roche or JnJ that have all talked about potentially selling their diabetes divisions? It's an interesting conversation, and one that may very well be rocking our world soon. "Conventional wisdom says "the only constant is change," and the CEO shifts we've been seeing could very well be a small ripple leading way to much bigger waves in the coming years." Source: www.healthline.com/diabetesmine/the-new-and-old-guard-a-year-of-changing-diabetes-ceosPerhaps MannKind will begin to make some waves in 2016. The BofD recent hired a new Chief Medical Officer Dr. Urbanski who, along with the newly appointed Director Dr. Shannon, has the pharmaceutical-development side of their business model covered. Now they've hired a CEO with a medical-device and disruptive technologies background. We may not see that "tsunami" many were hoping for, but it's beginning to look like a stronger management team is beginning to take shape that could start to make some waves. I remain hopeful and that is why I remain invested, but at some point we will need to see that all this is going somewhere. At any rate, at this point I am much less worried about management and a bit more worried about the financial health. I look forward to some clarity on the finances. I will rest a lot easier if I see that management has a plan that does not include a massive secondary offering.
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