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Post by rockstarrick on Aug 31, 2015 11:07:04 GMT -5
Thanks to all for replies. So if I recall correctly...MNKD mgmt. noted filing for EU shortly after FDA approval.. so maybe this will hit Asia/EU in 2015.. but how do they keep 'ultra' on the label? The real question is how do they keep it off ?? If Afrezza peaks 6 to 8 times faster than existing "Rapid Acting Analogs". And is out of your system before or close to the time digestion is complete. How can it only be "Rapid Acting" Afrezza eliminates most problems with Insulin Therapy due to the "Ultra Rapid" in and out. This won't be overlooked, not forever.
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Post by figglebird on Aug 31, 2015 11:08:03 GMT -5
Not saying it will not be approved in UK sooner or later but this repor does not seem to be connected to any actual agency does not provide anything substantive on a positive end(from my pov) - it is speculative and confusing at best as Insulin treatment from what I understand is 100pct covered by health services in UK so the fact that exhubra was denied coverage based on cost is not encouraging - higer efficasy could mitigate HOWEVER, in order to secure mass market in this and other global markets, cost may have to be substantially lowered - fortunately that is likely more than doable based on a number of factors.
Lastly, for those who are encouraged by the "first in class" labeling given may be misunderstanding what this really means, particularly from a payer standpoint - Afrezza has a different BIO AVAIL then sub q's and thus could not qualify as a bio similar. This was one of the major reasons I increased my long position by 200 pct.
Really it is the "only in class"
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Post by rockstarrick on Aug 31, 2015 13:12:48 GMT -5
Not saying it will not be approved in UK sooner or later but this repor does not seem to be connected to any actual agency does not provide anything substantive on a positive end(from my pov) - it is speculative and confusing at best as Insulin treatment from what I understand is 100pct covered by health services in UK so the fact that exhubra was denied coverage based on cost is not encouraging - higer efficasy could mitigate HOWEVER, in order to secure mass market in this and other global markets, cost may have to be substantially lowered - fortunately that is likely more than doable based on a number of factors. Lastly, for those who are encouraged by the "first in class" labeling given may be misunderstanding what this really means, particularly from a payer standpoint - Afrezza has a different BIO AVAIL then sub q's and thus could not qualify as a bio similar. This was one of the major reasons I increased my long position by 200 pct. Really it is the "only in class" And that is the reason for 1) The slow and controlled launch 2) The Dr and Patient Education Campaign 3) The slow uptick in prescriptions,(absolutely no historical data to compare to) 4) The Cautious Label Good Luck
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Post by mnholdem on Aug 31, 2015 13:57:44 GMT -5
Best in Class (or "Only in Class") does not automatically mean superiority. Empirical evidence must still be gathered to prove that claim. However, your quip of "only in class" does point out the obvious, as RSR highlights in #3, namely, that there is nothing comparison to Afrezza currently available in the diabetes market.
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Post by uvula on Aug 31, 2015 19:17:15 GMT -5
Small correction to original poster. It didn't improved A1C by .8% vs..4%, it improved it by .8 points vs. .4 points which is more like 10% if the initial A1c was 8.
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Post by mssciguy on Aug 31, 2015 19:23:20 GMT -5
Small correction to original poster. It didn't improved A1C by .8% vs..4%, it improved it by .8 points vs. .4 points which is more like 10% if the initial A1c was 8. Great observation. I wonder if there is an empirical longevity correction here.. My guess is a decade +/- ... this is one of the most relevant biomarkers out there
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Post by uvula on Aug 31, 2015 19:27:51 GMT -5
Actually 10% is not correct either. If someone has an A1c of 8 and a perfect A1C is 5, then going from 8 to 7.2 is an improvement of 30% or so. The goal is not to go from an A1C of 8 to 0. I'm not sure what the correct way to calculate this is but an improvement of .8 points is really really good.
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Post by mssciguy on Aug 31, 2015 19:28:58 GMT -5
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Post by liane on Aug 31, 2015 19:35:07 GMT -5
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Post by afrizzle on Sept 1, 2015 5:41:37 GMT -5
That's funny, the Mallomar pic came up pretty high in the ranking
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Post by liane on Sept 1, 2015 6:10:13 GMT -5
That's funny, the Mallomar pic came up pretty high in the ranking I noticed that too!
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Post by harryx1 on Sept 4, 2015 14:30:18 GMT -5
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Post by LongMNKD on Sept 5, 2015 8:41:50 GMT -5
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