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Post by liane on May 15, 2015 7:43:00 GMT -5
I would have moved all this except that jpg suggested it deserved its own thread. So maybe if people would talk about the abstract here, and the convention there. I'll try and move Harry's and all related posts here.
Done!
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Post by Chris-C on May 15, 2015 7:48:46 GMT -5
Well, I have a slightly different sentiment regarding the importance of the reduced hypoglycemia study report. While it isn't prospective in the sense that they specifically designed the study for this purpose and conducted it more recently, further analysis of existing data sets is becoming more common in order to extract greater benefit out of very expensive trials and to make use of advanced analytical techniques and computing power that enables such studies to be examined in more detail.
If memory serves, MNKD made it clear after announcing the primary endpoint data last year that there was rich data yet to be analyzed and that this analysis would continue and be reported in scientific journals and meetings. So, to be disappointed in the value of these findings because they are based on analysis of the 171 data seems unnecessarily critical to me. There are many existing data sets that are being analyzed asking different questions and yielding important insights these days. In fact, the government is funding centers to encourage better yields from existing data sets by training scientists to use the the latest techniques necessary to assure that findings reported are appropriately qualified and controlled so as to be deemed valid.
I think this is another piece of important evidence that helps substantiate what the company has been inferring all along (and what anecdotal evidence seems to support from early adopters.)
Chris C
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Post by mnholdem on May 15, 2015 7:53:11 GMT -5
Whichever doctors were responsible for getting it into the conference with the "breaking-news" label apparently are doing a little pumping on their own. I don't think Sanofi would have been able to do this, with the label restrictions imposed by the FDA. But doctor-to-doctor sharing and a little word of mouth amongst endocrinologists?
Pumpers at the conference? Rich!
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Post by kball on May 15, 2015 8:06:34 GMT -5
Harry beat you to it in another thread. Harry's like that old Midas commercial... Nobody Beats Harry. Nobody.
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Post by tripoley on May 15, 2015 8:22:26 GMT -5
It's a post-hoc analysis of 171 and although I don't think they can use it for label expansion (IDK, anybody know?) the results are still statistically significant with p-values less than 0.05.
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Post by jpg on May 15, 2015 8:52:05 GMT -5
Agreed this has value but no for label changes.
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Post by compound26 on Oct 6, 2016 17:21:44 GMT -5
Wondering if Mannkind has any plan to use the less hypo data for label change or anything else? I recall the studies showed a 30%/50% (can't recall exactly as I can not get access to the full report any more) plus reduction in hypo rate. www.easdvirtualmeeting.org/resources/reduced-hypoglycaemia-is-observed-with-inhaled-insulin-versus-subcutaneous-insulin-aspart-in-patients-with-type-1-diabetes-mellitus--2Interestingly, in the this video of Al Mann (the discussion regarding the hypo events starts at around 11 minutes of the video), it appears in the main study (I assume it is the study for Type ones, study 171), Al Mann mentioned that in that study, there is one person who accounted for more than half of all the hypo events in the study. Al Mann said in the video that Mannkind would investigate why this person had so many hypo events. Wonder if they have found anything. Anyway, if you take out that person (an outlier), the hypo events would have dropped another 50%. That would mean Afrezza probably reduced the hypo rate for all the other users (i.e., excluding this one outlier) by 75% plus. Imagine Mannkind can claim that in the label!
And this result seems to be consistent with the observations shared by the real world Afrezza users (that Afrezza is less likely to cause a hypo in the first place and even if it causes a hypo, because its fast-in and fast-out nature, the hypo event would be less severe). Wondering if Mannkind has any plan to use the less hypo data for label change or anything else?
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Post by saxcmann on Oct 6, 2016 19:48:27 GMT -5
Wondering if Mannkind has any plan to use the less hypo data for label change or anything else? I recall the studies showed a 30%/50% (can't recall exactly as I can not get access to the full report any more) plus reduction in hypo rate. www.easdvirtualmeeting.org/resources/reduced-hypoglycaemia-is-observed-with-inhaled-insulin-versus-subcutaneous-insulin-aspart-in-patients-with-type-1-diabetes-mellitus--2Interestingly, in the this video of Al Mann (the discussion regarding the hypo events starts at around 11 minutes of the video), it appears in the main study (I assume it is the study for Type ones, study 171), Al Mann mentioned that in that study, there is one person who accounted for more than half of all the hypo events in the study. Al Mann said in the video that Mannkind would investigate why this person had so many hypo events. Wonder if they have found anything. Anyway, if you take out that person (an outlier), the hypo events would have dropped another 50%. That would mean Afrezza probably reduced the hypo rate for all the other users (i.e., excluding this one outlier) by 75% plus. Imagine Mannkind can claim that in the label!
And this result seems to be consistent with the observations shared by the real world Afrezza users (that Afrezza is less likely to cause a hypo in the first place and even if it causes a hypo, because its fast-in and fast-out nature, the hypo event would be less severe). Wondering if Mannkind has any plan to use the less hypo data for label change or anything else? If they did and get approved it would be much better than "ultra" on label, my endo friend says. Unlikely because not enough data to support tho.
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Post by uvula on Oct 6, 2016 20:44:47 GMT -5
I started reading this thread and then realized it was over a year old.
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Post by bioexec25 on Oct 6, 2016 21:35:42 GMT -5
I started reading this thread and then realized it was over a year old. Lol. Same. I saw the Kball and the Fugacity comment then did a double take at the date.
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Post by rockstarrick on Oct 6, 2016 22:00:18 GMT -5
Wondering if Mannkind has any plan to use the less hypo data for label change or anything else? I recall the studies showed a 30%/50% (can't recall exactly as I can not get access to the full report any more) plus reduction in hypo rate. www.easdvirtualmeeting.org/resources/reduced-hypoglycaemia-is-observed-with-inhaled-insulin-versus-subcutaneous-insulin-aspart-in-patients-with-type-1-diabetes-mellitus--2Interestingly, in the this video of Al Mann (the discussion regarding the hypo events starts at around 11 minutes of the video), it appears in the main study (I assume it is the study for Type ones, study 171), Al Mann mentioned that in that study, there is one person who accounted for more than half of all the hypo events in the study. Al Mann said in the video that Mannkind would investigate why this person had so many hypo events. Wonder if they have found anything. Anyway, if you take out that person (an outlier), the hypo events would have dropped another 50%. That would mean Afrezza probably reduced the hypo rate for all the other users (i.e., excluding this one outlier) by 75% plus. Imagine Mannkind can claim that in the label!
And this result seems to be consistent with the observations shared by the real world Afrezza users (that Afrezza is less likely to cause a hypo in the first place and even if it causes a hypo, because its fast-in and fast-out nature, the hypo event would be less severe). Wondering if Mannkind has any plan to use the less hypo data for label change or anything else? If they did and get approved it would be much better than "ultra" on label, my endo friend says. Unlikely because not enough data to support tho. Not enough data to support "then" Give it time, we're just getting started.
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Post by rockstarrick on Oct 7, 2016 9:33:52 GMT -5
I'm thinking that the CGM data is pretty official, now that the FDA has given the nod to use their data to calculate insulin doses. Afrezza combined with a CGM and a good 24 HR Insulin appears to be the most convenient and efficient way to live with Diabetes. Al Mann knew this and predicted this years ago, it's just going to take a while for Afrezza to prove that Al was right.
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Post by cjc04 on Oct 7, 2016 12:55:00 GMT -5
I'm thinking that the CGM data is pretty official, now that the FDA has given the nod to use their data to calculate insulin doses. Afrezza combined with a CGM and a good 24 HR Insulin appears to be the most convenient and efficient way to live with Diabetes. Al Mann knew this and predicted this years ago, it's just going to take a while for Afrezza to prove that Al was right. I agree, my wife is doing really well WITHOUT a CGM, and she's not a carb counter. 5.7 a1c without a lot of effort. I will say one thing, she takes all her Afrezza after she eats, none before none during, all after. I know she could do better, I can't imagine how easy it would be if she had a CGM but it's too intrusive, she won't wear it. Anyway, what I really wanted to say to your point is, I still think it's interesting how MNKD publicly push its supporters to support Dexcom's FDA approval to use the CGM data. Obviously it helps their own cause, but silence on the issue ever since. Dying to know everything going on behind the scenes, and I still think the final separation agreement from SNY is the hold up for any new developments.
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Post by lennymnkd on Oct 7, 2016 13:08:07 GMT -5
I'm thinking that the CGM data is pretty official, now that the FDA has given the nod to use their data to calculate insulin doses. Afrezza combined with a CGM and a good 24 HR Insulin appears to be the most convenient and efficient way to live with Diabetes. Al Mann knew this and predicted this years ago, it's just going to take a while for Afrezza to prove that Al was right. Agree , as clean a story as that . At the end of the day this is what will be , make perfect sense .
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