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Post by bobw on Jun 28, 2014 18:35:36 GMT -5
silentbob, those are two points that I was bothered by when I read the label. Thanks for posting them. Other than that and the boxed warning it was not such a bad label. It could have been much worse.
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Post by alcc on Jun 28, 2014 19:04:27 GMT -5
Another omission that proves the FDA is not our friend can be seen in the FEV1 explanation and graphics. All the trials have shown that the small reduction in FEV1 was completely reversible after stopping Afrezza usage. This was measured in the followup visits and was very clear in Mannkind's graphics. The FDA completely ignored this important qualifier and even stripped it from the graph. Why do they want to keep the facts hidden? I did not notice that omission. I wonder if that's agency's way of "accounting/imputing" for the high dropout/"missing data". I reiterate: thank god for the adcom; otherwise not at all sure we would not have gotten a 3rd CRL given the distinctly antagonistic adcom briefing doc.
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Post by noonen on Jun 28, 2014 23:04:43 GMT -5
Less of an issue now, since we have approval, but the FEV1 explanation by the company has always struck me as a little weird.
I may be in the minority, but chopping off the end of that lung function graph by the fda doesn't really bother me. It's great that the lung function returns to normal after the inhaler is no longer used, but what kind of support is that for using this inhaler for diabetes? Lung function goes back to normal, but then your diabetes goes crazy again?
I always thought that the real value of the FEV results was that the reduction in lung function was so minor compared to non-afrezza users that it didn't really matter. That feels like a stronger argument imo.
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Post by silentbob on Jun 30, 2014 2:41:38 GMT -5
Less of an issue now, since we have approval, but the FEV1 explanation by the company has always struck me as a little weird. I may be in the minority, but chopping off the end of that lung function graph by the fda doesn't really bother me. It's great that the lung function returns to normal after the inhaler is no longer used, but what kind of support is that for using this inhaler for diabetes? Lung function goes back to normal, but then your diabetes goes crazy again? I always thought that the real value of the FEV results was that the reduction in lung function was so minor compared to non-afrezza users that it didn't really matter. That feels like a stronger argument imo. Noonen, you have a point in saying that the reversion in FEV1 reduction on quitting Afrezza may not have practical implications, since most diabetics are on insulin for life. However the point is that the reversal proves that the reduction in FEV1 is due to temporary changes (eg additional mucus in the lungs) and not due to any kind of damage to the lungs.
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Post by noonen on Jun 30, 2014 4:15:38 GMT -5
Less of an issue now, since we have approval, but the FEV1 explanation by the company has always struck me as a little weird. I may be in the minority, but chopping off the end of that lung function graph by the fda doesn't really bother me. It's great that the lung function returns to normal after the inhaler is no longer used, but what kind of support is that for using this inhaler for diabetes? Lung function goes back to normal, but then your diabetes goes crazy again? I always thought that the real value of the FEV results was that the reduction in lung function was so minor compared to non-afrezza users that it didn't really matter. That feels like a stronger argument imo. Noonen, you have a point in saying that the reversion in FEV1 reduction on quitting Afrezza may not have practical implications, since most diabetics are on insulin for life. However the point is that the reversal proves that the reduction in FEV1 is due to temporary changes (eg additional mucus in the lungs) and not due to any kind of damage to the lungs. Thanks Silentbob, that makes sense. Seeing that the reduction isn't permanent and that there is no damage to the lung is clearly a positive. If it's just a little extra mucus, I'm assuming nobody's going to care much about that if they can control the diabetes.
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