|
Post by peppy on Mar 13, 2018 10:11:44 GMT -5
Until today I didn’t know what STAT stood for. I assumed it was some type of standard drug comparison test. And since it is not a standard recognized acronym I wonder why they used it in the presentation titles without defining it in the titles. What is the meaning of the abbreviation stat? STAT: A common medical abbreviation for urgent or rush. From the Latin word statum, meaning 'immediately.' When a physician is calling a code, they need everything STAT.
|
|
|
Post by uvula on Mar 13, 2018 10:16:23 GMT -5
Peppy, yes stat is a standard medical term, but in this case STAT stands for STudy comparing insulin Aspart versus Technosphere insulin. Very few people reading the titles will know that.
|
|
|
Post by uvula on Mar 13, 2018 10:21:30 GMT -5
It is also strange that they call it a STAT study when the ST stands for study. It is therefore a study study.
|
|
|
Post by zuegirdor on Mar 13, 2018 10:41:34 GMT -5
jmkopp. It's not their study. It was conducted by the University of Colorado, IIRC. The University has complete control over when, even if, the results will be published. This STAT crew and location is the same research center and author of the paper on Methyl-Dopa "cure" for type 1 immunological misfire that I posted on a month ago www.jci.org/articles/view/97739/pdf in a thread titled "counting down to a cure for type 1 diabetes" Interesting connection!
|
|
|
Post by liane on Mar 13, 2018 11:01:34 GMT -5
It is also strange that they call it a STAT study when the ST stands for study. It is therefore a study study. It seems every study has to have an acronym (personally I think it's stupid). So I think they often have to take license to come up with a catchy one.
|
|
|
Post by traderdennis on Mar 13, 2018 11:03:10 GMT -5
June 22-26 2018 is not 6 months away I think the study was completed in December, wasn’t it? I am ignorant on how studies work for presentations, but is it possible the study is under peer review so that it can be presented at the conference post peer review.
|
|
|
Post by dreamboatcruise on Mar 13, 2018 11:09:22 GMT -5
Does it irritate anyone else that a Company that is financially struggling a bit and having a little trouble gaining better insurance coverage and visibility in the marketplace with their amazing drug that will change the way Diabetes is treated; has to wait an additional 6 months to be able to present their study at the ADA? Wouldn't you think the ADA would want this information to get out to the marketplace as quickly as possible to potentially save more lives rather than force MNKD to wait an additional 6 months just to have the honor of presenting the material at the convention. Does the ADA care more about forcing only presentations that have never been published in an effort to reap the financial benefit of selling more tickets to the event? So, 6 months more of dilution and 6 months more of physicians not getting this knowledge and 6 months longer of low visibility of Afrezza and 6 months longer of weak insurance coverage just to sell a few more tickets to the convention. What am I not understanding about this? Thx. Likely for a majority of studies being presented there, the authors would consider that they have done something that is useful to advancing medicine and/or helping patients. It would be hard to have the policy at all and then get into handing out waivers because more expedient release of the information would be deemed helpful to health in some way. I'm sure in the ADA leadership's minds, assuring a successful conference is of importance to patients, and the rule about not allowing previously published info important to that end. Yes, it would be nice if the results got presented earlier and if MNKD had conducted the trials themselves they would have had the freedom to release and publish/present elsewhere. Maybe MNKD has freedom to present this info to insurers under terms of confidentiality.
|
|
|
Post by peppy on Mar 13, 2018 11:19:35 GMT -5
Does it irritate anyone else that a Company that is financially struggling a bit and having a little trouble gaining better insurance coverage and visibility in the marketplace with their amazing drug that will change the way Diabetes is treated; has to wait an additional 6 months to be able to present their study at the ADA? Wouldn't you think the ADA would want this information to get out to the marketplace as quickly as possible to potentially save more lives rather than force MNKD to wait an additional 6 months just to have the honor of presenting the material at the convention. Does the ADA care more about forcing only presentations that have never been published in an effort to reap the financial benefit of selling more tickets to the event? So, 6 months more of dilution and 6 months more of physicians not getting this knowledge and 6 months longer of low visibility of Afrezza and 6 months longer of weak insurance coverage just to sell a few more tickets to the convention. What am I not understanding about this? Thx. Likely for a majority of studies being presented there, the authors would consider that they have done something that is useful to advancing medicine and/or helping patients. It would be hard to have the policy at all and then get into handing out waivers because more expedient release of the information would be deemed helpful to health in some way. I'm sure in the ADA leadership's minds, assuring a successful conference is of importance to patients, and the rule about not allowing previously published info important to that end. Yes, it would be nice if the results got presented earlier and if MNKD had conducted the trials themselves they would have had the freedom to release and publish/present elsewhere. Maybe MNKD has freedom to present this info to insurers under terms of confidentiality. Dr. Kendall served as Chief Scientific and Medical Officer at the American Diabetes Association, where he was responsible for all medical affairs, medical education, research, outcomes, and medical policy activities. “MannKind welcomes the opportunity to share the results of this collaborative clinical trial and looks forward to pursuing additional analyses to assess the clinical use of Afrezza therapy for mealtime glucose control,” stated David Kendall, MD, Chief Medical Officer of MannKind Corporation. “We believe that the STAT Study results will offer important insights into ways that individuals with diabetes can potentially improve their experience and outcomes by using mealtime inhaled insulin ’in the moment.‘ Our long-term goal is to establish inhaled human insulin as both a useful option and a potential treatment of choice for those individuals with diabetes requiring mealtime glucose control.” *Afrezza, (insulin human) In the moment.
|
|
|
Post by celo on Mar 13, 2018 11:41:23 GMT -5
Likely for a majority of studies being presented there, the authors would consider that they have done something that is useful to advancing medicine and/or helping patients. It would be hard to have the policy at all and then get into handing out waivers because more expedient release of the information would be deemed helpful to health in some way. I'm sure in the ADA leadership's minds, assuring a successful conference is of importance to patients, and the rule about not allowing previously published info important to that end. Yes, it would be nice if the results got presented earlier and if MNKD had conducted the trials themselves they would have had the freedom to release and publish/present elsewhere. Maybe MNKD has freedom to present this info to insurers under terms of confidentiality. Dr. Kendall served as Chief Scientific and Medical Officer at the American Diabetes Association, where he was responsible for all medical affairs, medical education, research, outcomes, and medical policy activities. “MannKind welcomes the opportunity to share the results of this collaborative clinical trial and looks forward to pursuing additional analyses to assess the clinical use of Afrezza therapy for mealtime glucose control,” stated David Kendall, MD, Chief Medical Officer of MannKind Corporation. “We believe that the STAT Study results will offer important insights into ways that individuals with diabetes can potentially improve their experience and outcomes by using mealtime inhaled insulin ’in the moment.‘ Our long-term goal is to establish inhaled human insulin as both a useful option and a potential treatment of choice for those individuals with diabetes requiring mealtime glucose control.” *Afrezza, (insulin human) In the moment. Not a big fan of the word potentially. After the STAT study I was hoping it is or it isn't. I'm assuming he is referring to those individuals with respiratory issues that may be unable to use Afrezza. I know knit picking but it would be nice to say it improves experiences and outcomes period.
|
|
|
Post by mnholdem on Mar 13, 2018 11:44:35 GMT -5
I think the study was completed in December, wasn’t it? I am ignorant on how studies work for presentations, but is it possible the study is under peer review so that it can be presented at the conference post peer review. Peer review is critical for publication of studies in major medical journals (e.g. Lancet). Sadly, publications about Afrezza in these journals has been lacking. IMO, if you want to win over physicians, your studies/trials must pass this peer-review litmus test.
|
|
|
Post by peppy on Mar 13, 2018 12:11:41 GMT -5
I can not wait for the peer reviews. Dr Kendall has to know some peers? RAA. Afrezza. (In the moment)
|
|
|
Post by hans on Mar 13, 2018 12:18:47 GMT -5
I am ignorant on how studies work for presentations, but is it possible the study is under peer review so that it can be presented at the conference post peer review. Peer review is critical for publication of studies in major medical journals (e.g. Lancet). Sadly, publications about Afrezza in these journals has been lacking. IMO, if you want to win over physicians, your studies/trials must pass this peer-review litmus test.
Any idea on how many physicians will be reviewing the data for the publication and whether the publication will get out in time for the ADA conference in June?
|
|
|
Post by rockstarrick on Mar 13, 2018 12:21:10 GMT -5
Dr. Kendall served as Chief Scientific and Medical Officer at the American Diabetes Association, where he was responsible for all medical affairs, medical education, research, outcomes, and medical policy activities. “MannKind welcomes the opportunity to share the results of this collaborative clinical trial and looks forward to pursuing additional analyses to assess the clinical use of Afrezza therapy for mealtime glucose control,” stated David Kendall, MD, Chief Medical Officer of MannKind Corporation. “We believe that the STAT Study results will offer important insights into ways that individuals with diabetes can potentially improve their experience and outcomes by using mealtime inhaled insulin ’in the moment.‘ Our long-term goal is to establish inhaled human insulin as both a useful option and a potential treatment of choice for those individuals with diabetes requiring mealtime glucose control.” *Afrezza, (insulin human) In the moment. Not a big fan of the word potentially. After the STAT study I was hoping it is or it isn't. I'm assuming he is referring to those individuals with respiratory issues that may be unable to use Afrezza. I know knit picking but it would be nice to say it improves experiences and outcomes period. Hard to say anything other than “potentially” for a drug used for “chronic” diseases such as Diabetes, where patients are self medicating, (for lack of a better term). Results will vary depending on how well the PWD is managing their disease.
|
|
|
Post by matt on Mar 13, 2018 14:20:40 GMT -5
I can not wait for the peer reviews. Dr Kendall has to know some peers? That is not how peer review works. There are peer-review panels for each publication and the ones looking at any given article, normally three reviewers, are chosen at random from that panel. The peer-reviewers are blinded to the extent possible with the trade names of the drug blacked out, the name of the study blacked out, and the author(s) of the study not revealed. A well-informed reviewer might be able to make an intelligent guess as to which study and which product, but that is far from a certainty. In any case, the company does not interact with the reviewers at any point so who Dr. Kendall may or may not know doesn't factor into the process.
|
|
|
Post by peppy on Mar 13, 2018 14:28:42 GMT -5
I can not wait for the peer reviews. Dr Kendall has to know some peers? That is not how peer review works. There are peer-review panels for each publication and the ones looking at any given article, normally three reviewers, are chosen at random from that panel. The peer-reviewers are blinded to the extent possible with the trade names of the drug blacked out, the name of the study blacked out, and the author(s) of the study not revealed. A well-informed reviewer might be able to make an intelligent guess as to which study and which product, but that is far from a certainty. In any case, the company does not interact with the reviewers at any point so who Dr. Kendall may or may not know doesn't factor into the process. even better, mystery drug A and B with end points. 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 ]
|
|