Study 171: FDA contradict itself on page 84 and 85???
Mar 28, 2014 15:10:14 GMT -5
spiro, thekindaguyiyam, and 2 more like this
Post by jpg on Mar 28, 2014 15:10:14 GMT -5
1- When making comments on the efficacy of Afrezza to lower FPG (Page 84 of 248 pages) the reviewer comments that the lower FPG may be due to more basal insulin. Logical if taken in isolation.
2-Then the reviewer says on the next page (85 of 248) that there is less weight gain in 171 with Afrezza but this is difficult to Interpret considering the different efficacy of both mealtime insulins. Again logical conclusion taken in isolation.
The problem is that both of these statements (1 and 2 above) are by definition linked and this link should have been noted in anything other then a simplistic understanding of how diabetic treatment and insulin interactions work. Basically both the above reviewers conclusions can't be right. It is as if the reviewer doesn't go past a simplistic primary view of data. Hopefully experts from the selected panel will have a better understanding of all this and that Mannkind will be able to pint out this glaring inconsistency in the FDA reviewers understanding of the data and of how different insulins (basal and prandial) interact to affect weight gain and FPG.
JPG
PS: not a fun day...
2-Then the reviewer says on the next page (85 of 248) that there is less weight gain in 171 with Afrezza but this is difficult to Interpret considering the different efficacy of both mealtime insulins. Again logical conclusion taken in isolation.
The problem is that both of these statements (1 and 2 above) are by definition linked and this link should have been noted in anything other then a simplistic understanding of how diabetic treatment and insulin interactions work. Basically both the above reviewers conclusions can't be right. It is as if the reviewer doesn't go past a simplistic primary view of data. Hopefully experts from the selected panel will have a better understanding of all this and that Mannkind will be able to pint out this glaring inconsistency in the FDA reviewers understanding of the data and of how different insulins (basal and prandial) interact to affect weight gain and FPG.
JPG
PS: not a fun day...