|
|
Post by peppy on Jun 26, 2018 20:51:15 GMT -5
And one more thing, the "8.0 to 6.8" was from the the Affinity 1 which had 518 participants which should be enough to stop the whiners about STAT only having 60 and not being big enough. clinicaltrials.gov/ct2/show/NCT01445951so this was the vein of gold. |
|
|
|
Post by traderdennis on Jun 26, 2018 20:53:26 GMT -5
You guys can spin it all you want but reducing time spent in hypoglycemia (i.e., <70 mg/dl) by 41% and increasing time-in-range by an average 12% per day is a big deal over years of a diabetics life.  There is no emergency room visit between 50 and 70. Where is the data for severe hypos? There are plenty of protocols pwd do with hypos in the 40 to 70 range. That’s why this study will not fly with thre insurance providers and there is no significance in the data for SEVERE hypos. |
|
|
|
Post by peppy on Jun 26, 2018 20:59:40 GMT -5
here is the confusion. The STAT was presented in two parts. Then additionally the hypoglycemia poster data was presented. find the data. I want to read the whole studies/presentations/papers. Mike C, and MNKD, are we going to get access to the full texts? or do we have assess to the full text and I am the last to know?  |
|
|
|
Post by agedhippie on Jun 26, 2018 22:35:17 GMT -5
And one more thing, the "8.0 to 6.8" was from the the Affinity 1 which had 518 participants which should be enough to stop the whiners about STAT only having 60 and not being big enough. clinicaltrials.gov/ct2/show/NCT01445951Lets take that apart and look at it. There were 518 people in all the arms of the study which looks ok to me, but where in the study does it mention 8.0 to 6.8 ? The only result I can see is 7.98 to 7.77 (a drop of 0.21) for Afrezza with Dreamboat, and 7.88 to 7.48 (a drop of 0.40) for Novolog. Interestingly the Medtone inhaler outperformed the Dreamboat inhaler, never noticed that before! |
|
|
|
Post by peppy on Jun 26, 2018 22:44:56 GMT -5
And one more thing, the "8.0 to 6.8" was from the the Affinity 1 which had 518 participants which should be enough to stop the whiners about STAT only having 60 and not being big enough. clinicaltrials.gov/ct2/show/NCT01445951Lets take that apart and look at it. There were 518 people in all the arms of the study which looks ok to me, but where in the study does it mention 8.0 to 6.8 ? The only result I can see is 7.98 to 7.77 (a drop of 0.21) for Afrezza with Dreamboat, and 7.88 to 7.48 (a drop of 0.40) for Novolog. Interestingly the Medtone inhaler outperformed the Dreamboat inhaler, never noticed that before! here is the problem. see it?  This is from affinity. The poster. |
|
|
|
Post by peppy on Jun 26, 2018 22:49:48 GMT -5
we have differing data from stat, which includes HgA1c, so it is which presentation? From memory, and my work that wasn't far off from the posted stuff, a 30% reduction in severe hypoglycemia.  |
|
|
|
Post by sayhey24 on Jun 27, 2018 5:37:19 GMT -5
And one more thing, the "8.0 to 6.8" was from the the Affinity 1 which had 518 participants which should be enough to stop the whiners about STAT only having 60 and not being big enough. clinicaltrials.gov/ct2/show/NCT01445951Lets take that apart and look at it. There were 518 people in all the arms of the study which looks ok to me, but where in the study does it mention 8.0 to 6.8 ? The only result I can see is 7.98 to 7.77 (a drop of 0.21) for Afrezza with Dreamboat, and 7.88 to 7.48 (a drop of 0.40) for Novolog. Interestingly the Medtone inhaler outperformed the Dreamboat inhaler, never noticed that before! Aged - all I can suggest is go back and read the poster. I don't make this stuff up. The medtone held 33% more powder so getting a little more into the lungs is not surprising but supports the position that taking a little more won't significantly increase the hypos.
As I said last night, we have a well defined path for Dr. Kendall to move forward and get changes to the standard of care. Guys like RisingSkeptic are probably on suicide watch right now. I hope you don't take the great news on the studies as hard.
While many would like to see TV commercials and sales guys hitting the street. IMO the biggest sales tool is the SOC. I don't see many commercials for Medformin buts it 1# for the T2s and as Ralph DeFronzio has said - "the biggest waste of time in treating T2s". Once Dr. Kendall gets afrezza inserted for Medformin its a whole new ball game and we probably need fewer sales guys not more.
|
|
|
|
Post by sla55 on Jun 27, 2018 7:12:42 GMT -5
|
|
|
|
Post by oldfishtowner on Jun 27, 2018 8:23:38 GMT -5
STAT was a Phase 4 investigator initiated study. Participant size was sufficient and adequate. There is a lot of misguided information being tossed about regarding the STAT study.
Clinicaltrials.gov does describe the STAT study as a phase 4 study, but it also says it is a pilot study and not a pivotal study, that is, it is to provide information to guide further research, likely a pivotal study that would have more subjects and be of longer duration, namely, the dynamic dosing study.
The STAT study is what it is. Let's not over hype it or dismiss it out of hand. There are issues with how the data were analyzed and presented, but the results are positive and sufficiently convincing, and together with the hypo paper, as Peppy rightly points out, sends a powerful message.
|
|
|
|
Post by peppy on Jun 27, 2018 8:27:11 GMT -5
STAT was a Phase 4 investigator initiated study. Participant size was sufficient and adequate. There is a lot of misguided information being tossed about regarding the STAT study.
Clinicaltrials.gov does describe the STAT study as a phase 4 study, but it also says it is a pilot study and not a pivotal study, that is, it is to provide information to guide further research, likely a pivotal study that would have more subjects and be of longer duration, namely, the dynamic dosing study.
The STAT study is what it is. Let's not over hype it or dismiss it out of hand. There are issues with how the data were analyzed and presented, but the results are positive and sufficiently convincing, and together with the hypo paper, as Peppy rightly points out, sends a powerful message.
However, the 2018 standards of care, has a new suggestion. Trials with Continuous glucose monitors with a two week time frame. The STAT doubles the new CGM suggested two week trial time frame. |
|
|
|
Post by agedhippie on Jun 27, 2018 8:42:57 GMT -5
Lets take that apart and look at it. There were 518 people in all the arms of the study which looks ok to me, but where in the study does it mention 8.0 to 6.8 ? The only result I can see is 7.98 to 7.77 (a drop of 0.21) for Afrezza with Dreamboat, and 7.88 to 7.48 (a drop of 0.40) for Novolog. Interestingly the Medtone inhaler outperformed the Dreamboat inhaler, never noticed that before! Aged - all I can suggest is go back and read the poster. I don't make this stuff up. The medtone held 33% more powder so getting a little more into the lungs is not surprising but supports the position that taking a little more won't significantly increase the hypos.
As I said last night, we have a well defined path for Dr. Kendall to move forward and get changes to the standard of care. Guys like RisingSkeptic are probably on suicide watch right now. I hope you don't take the great news on the studies as hard.
While many would like to see TV commercials and sales guys hitting the street. IMO the biggest sales tool is the SOC. I don't see many commercials for Medformin buts it 1# for the T2s and as Ralph DeFronzio has said - "the biggest waste of time in treating T2s". Once Dr. Kendall gets afrezza inserted for Medformin its a whole new ball game and we probably need fewer sales guys not more.
Peppy posted the relevant section and now I understand. The 6.8 was an arbitrary number to use as a comparison for hypos (why 6.8 anyway? A more obvious number would be 6.5) and not related to the average Afrezza HbA1c after treatment which was 7.77 and not 6.8. I suspect 6.8 was picked because the range was more limited for the Afrezza arm (18% made it below 7.0 after 3 months, and 6.20 was the lowest A1c) vs. the Novolog arm (30% made it below 7.0 and 5.800 was the lowest A1c). At this point someone is going to say it's because there were more hypos and the problem is we do not have the data to see if all the hypos are concentrated in a few people (a problem in the Afrezza Type 2 trial. I seem to recall Al saying that all the hypos were one person which made things look bad), or spread out. The total number of hypos in each arm over 3 months were 96 for Afrezza, and 99 for Novolog. Severe hypos were 18 for Afrezza, and 29 for Novolog. That is not going to impact an A1c over 3 months and 514 people unless it is concentrated in a few individuals (thinking of that 5.80 A1c in the Novolog arm) The STAT data on the other hand does seem clearer, but for a short duration and population size which is fair since it is a pilot. We need STAT-2 with a decent sized population. |
|
|
|
Post by traderdennis on Jun 27, 2018 8:43:12 GMT -5
STAT was a Phase 4 investigator initiated study. Participant size was sufficient and adequate. There is a lot of misguided information being tossed about regarding the STAT study.
Clinicaltrials.gov does describe the STAT study as a phase 4 study, but it also says it is a pilot study and not a pivotal study, that is, it is to provide information to guide further research, likely a pivotal study that would have more subjects and be of longer duration, namely, the dynamic dosing study.
The STAT study is what it is. Let's not over hype it or dismiss it out of hand. There are issues with how the data were analyzed and presented, but the results are positive and sufficiently convincing, and together with the hypo paper, as Peppy rightly points out, sends a powerful message.
Wow. That is what Osborne has said for months about the stat study. |
|
|
|
Post by kite on Jun 27, 2018 8:52:13 GMT -5
Is anyone here attending this event today?
|
|
|
|
Post by awesomo on Jun 27, 2018 8:53:44 GMT -5
Hopefully someone that can breathe life into this share price.
|
|
|
|
Post by mnkdfann on Jun 27, 2018 8:58:21 GMT -5
Is anyone here attending this event today? In another thread, you said you registered and reported that Mannkind said they would send you a confirmation. Did they, and are YOU attending? |
|
