Dr. Kendall presents the STAT study.
Jul 18, 2018 15:05:35 GMT -5
edvarney, chc, and 3 more like this
Post by peppy on Jul 18, 2018 15:05:35 GMT -5
lifesci.rampard.com/20180627/reg.jsp#
thank you compound.
From compound26
After listening to Dr Kendall's presentation to the investors yesterday, I now can clearly see that the STAT trial results are very significant. For anyone interested, please listen to the presentation, especially starting from about 1 hour into the presentation where Dr. Kendall discussed the details about the STAT trial. Here is the link to the replay of the presentation. lifesci.rampard.com/20180627/index.jsp#
Based on Dr. Kendall’s presentation, here are my thoughts:
1. For the dosing compliant group, if you look at the charts included in the slides shown during presentation, the BG level of Afrezza group vs the RAA group at 1 hour after meal is roughly 145 vs 185.
You can draw your own conclusion whether that is significant or not or whether Afrezza is superior on that front.
2. The above obviously superior result is achieved while the Afrezza arm of patients are clearly under-dosing themselves.
Dr. Kendall explained that, for the trail purpose, the dosing is set to be 1 to 1, i.e., if a patient used to take 1 unit of RAA, he is taking 1 unit of Afrezza for the trial. Jeremy H. Pettus, MD has commented that, “based on clinical experience, 4 units of Afrezza is roughly equivalent to 2.5 units of SC insulin. [see slide 77 of this Medscape Education presentation]. That observation is line with many Afrezza users’ experience who shared their experience on social media.
Based on the above, if properly dosed, I am pretty certain the BG level of Afrezza group vs the RAA group at 1 hour after meal will be even more impressive than 145 vs 185 as achieved by the STAT trial. 125 vs 185 will certainly be an attainable target here as there is little hypo concern with Afrezza when taken at a relatively high BG level.
3. The 12% improvement in range in time is also very significant improvement. To bring that data point into context, Dr. Kendall noted that the 12% improvement in range in time with Afrezza is basically the same improvement that CGMs achieved when CGMs first got FDA approval. And Dr. Edelman is stating CMGs is now standard of care.
4. And in my personal opinion there are many other reasons why the STAT results could be even better if better trial protocols are used. You can read Sam’s article on this particular subject: How come Afrezza is WAY better now than on the Trials?
5. Dr. Kendall further noted that over the entire history of insulin development, no new insulin actually has clearly out-performed competition within same class. Afrezza is the only exception based on the STAT trial data.
Read more: mnkd.proboards.com/thread/9851/david-kendall-effect?page=8#ixzz5Ldk6ZmE9
thank you compound.
From compound26
After listening to Dr Kendall's presentation to the investors yesterday, I now can clearly see that the STAT trial results are very significant. For anyone interested, please listen to the presentation, especially starting from about 1 hour into the presentation where Dr. Kendall discussed the details about the STAT trial. Here is the link to the replay of the presentation. lifesci.rampard.com/20180627/index.jsp#
Based on Dr. Kendall’s presentation, here are my thoughts:
1. For the dosing compliant group, if you look at the charts included in the slides shown during presentation, the BG level of Afrezza group vs the RAA group at 1 hour after meal is roughly 145 vs 185.
You can draw your own conclusion whether that is significant or not or whether Afrezza is superior on that front.
2. The above obviously superior result is achieved while the Afrezza arm of patients are clearly under-dosing themselves.
Dr. Kendall explained that, for the trail purpose, the dosing is set to be 1 to 1, i.e., if a patient used to take 1 unit of RAA, he is taking 1 unit of Afrezza for the trial. Jeremy H. Pettus, MD has commented that, “based on clinical experience, 4 units of Afrezza is roughly equivalent to 2.5 units of SC insulin. [see slide 77 of this Medscape Education presentation]. That observation is line with many Afrezza users’ experience who shared their experience on social media.
Based on the above, if properly dosed, I am pretty certain the BG level of Afrezza group vs the RAA group at 1 hour after meal will be even more impressive than 145 vs 185 as achieved by the STAT trial. 125 vs 185 will certainly be an attainable target here as there is little hypo concern with Afrezza when taken at a relatively high BG level.
3. The 12% improvement in range in time is also very significant improvement. To bring that data point into context, Dr. Kendall noted that the 12% improvement in range in time with Afrezza is basically the same improvement that CGMs achieved when CGMs first got FDA approval. And Dr. Edelman is stating CMGs is now standard of care.
4. And in my personal opinion there are many other reasons why the STAT results could be even better if better trial protocols are used. You can read Sam’s article on this particular subject: How come Afrezza is WAY better now than on the Trials?
5. Dr. Kendall further noted that over the entire history of insulin development, no new insulin actually has clearly out-performed competition within same class. Afrezza is the only exception based on the STAT trial data.
Read more: mnkd.proboards.com/thread/9851/david-kendall-effect?page=8#ixzz5Ldk6ZmE9
