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Post by mssciguy on Aug 30, 2015 17:12:36 GMT -5
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Post by mssciguy on Aug 30, 2015 18:01:36 GMT -5
decreased A1c by 0.8% vs 0.4% for orals alone...
this is better than the official FDA reception in the US from what I can tell
What do the doctors on board think?
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Post by kc on Aug 30, 2015 18:43:10 GMT -5
Approval coming SHORTLY. Now that seems like a fitting statement.
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Post by mike0475 on Aug 30, 2015 19:35:55 GMT -5
Approval coming SHORTLY. Now that seems like a fitting statement. How do you deem shortly from this document?
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Post by kc on Aug 30, 2015 19:41:18 GMT -5
Shortly means within 12 months or sooner. Things are happening behind the scene that we will not know about until it's announced. Afrezza will be a global product for Sanofi.
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Post by mike0475 on Aug 30, 2015 19:41:53 GMT -5
Shortly means within 12 months or sooner. 12mo or sooner from when? Per?
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Post by rockstarrick on Aug 30, 2015 21:13:53 GMT -5
Approval coming SHORTLY. Now that seems like a fitting statement. How do you deem shortly from this document? I believe there is a timeframe after p3 trials in which you must file for approval, anybody know. Trials complete in UK, P3 in Europe, and the label Sanofi was shooting for. its all good
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Post by rozale on Aug 30, 2015 23:51:08 GMT -5
Good / neutral news to me. In the notes it said exubera was not covered due to cost effectiveness, cost was 1100 pounds annually (in 2006). It also says afrezza is estimated to cost ~$7.5 a day (about 2750 usd a year). That's about 1780 pounds annually today.
I'm just hoping that the cost isn't prohibitive like it was for exubera.
Either way good find, thanks for sharing!
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Post by rockstarrick on Aug 31, 2015 5:27:52 GMT -5
Good / neutral news to me. In the notes it said exubera was not covered due to cost effectiveness, cost was 1100 pounds annually (in 2006). It also says afrezza is estimated to cost ~$7.5 a day (about 2750 usd a year). That's about 1780 pounds annually today. I'm just hoping that the cost isn't prohibitive like it was for exubera. Either way good find, thanks for sharing! This is the same information from 2014, it says available in UK in 2015 It seems Sanofi has been working on this for at least a year. Sneaky www.ukmi.nhs.uk/filestore/ukmianp/2014PrescribingOutlook-NewMedicines2014-FINAL.pdfAround page 34. It changes via iPad, iPhone or Laptop or Desktop.
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Post by rockstarrick on Aug 31, 2015 5:30:06 GMT -5
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Post by rockstarrick on Aug 31, 2015 5:37:37 GMT -5
Good / neutral news to me. In the notes it said exubera was not covered due to cost effectiveness, cost was 1100 pounds annually (in 2006). It also says afrezza is estimated to cost ~$7.5 a day (about 2750 usd a year). That's about 1780 pounds annually today. I'm just hoping that the cost isn't prohibitive like it was for exubera. Either way good find, thanks for sharing! This label "Ultra Rapid Acting, First In Class" shows Superiority, not non inferiority. Exhubra didn't have this. Afrezza will be covered. I think we are actually getting beyond the Exhubra fatigue finally. I hope they drop the Spirometry Requirement in UK and Europe also. Sanofi knows what they are doing !!! Patience Mannkind Longs Good Luck Rock
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Post by mike0475 on Aug 31, 2015 7:54:29 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?
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Post by yossarian on Aug 31, 2015 9:57:20 GMT -5
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Post by mssciguy on Aug 31, 2015 10:14:00 GMT -5
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Post by mike0475 on Aug 31, 2015 10:49:05 GMT -5
again, how do we get ultra tagged for overseas.. their announcement simply pending improvement study in US? Will that occur in 15?
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