Deleted
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Post by Deleted on Oct 19, 2014 5:46:44 GMT -5
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Post by cybergym66 on Oct 19, 2014 6:39:24 GMT -5
I checked the information you provided in the links...1st link says in phase III in UK/EU, the 2nd link to a doc is dated July 2014, the last says "Afrezza® is currently in Phase III development in the UK and US. It is predicted for launch in the UK in 2015. "
So please point me to where it says EU filed. Thanks!
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Post by Deleted on Oct 19, 2014 6:42:11 GMT -5
I checked the information you provided in the links...1st link says in phase III in UK/EU, the 2nd link to a doc is dated July 2014, the last says "Afrezza® is currently in Phase III development in the UK and US. It is predicted for launch in the UK in 2015. " So please point me to where it says EU filed. Thanks! Obviously you missed the "?" In the subject  ? Also "Sanofi" as the company name in the first link would imply they more than likely were the source of information, would it not? |
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Post by cybergym66 on Oct 19, 2014 6:47:31 GMT -5
I checked the information you provided in the links...1st link says in phase III in UK/EU, the 2nd link to a doc is dated July 2014, the last says "Afrezza® is currently in Phase III development in the UK and US. It is predicted for launch in the UK in 2015. " So please point me to where it says EU filed. Thanks! Obviously you missed the "?" In the subject ? Also "Sanofi" as the company name in the first link would imply they more than likely were the source of information, would it not? Strange subject title...seems to ask for confirmation of an EU filing... |
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Post by mnholdem on Oct 19, 2014 7:12:20 GMT -5
We've known of the EU trials in preparation for EMA application for centralized marketing authorization for some time. To my knowledge, the actual EMA application for Afrezza must be available to the public. None of these links are confirmation the application is done.
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Post by mannmade on Oct 19, 2014 12:12:48 GMT -5
Does anyone know anything about the full EU filing and approval process? With an FDA filing we know you have to first complete Phase 3"s then file. Perhaps the process is different for EU especially with an FDA approval already in hand, that is a shorter process or use of info from US studies as part of concurrent EU studies?
Seems to me if not, then we would need to know expected date of completion of phase 3's and then the time it will take to file and and lastly the normal response time. Hard to project anything without such information it would seem... Just my opinion...
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Post by papihoyos on Oct 19, 2014 15:49:32 GMT -5
Does anyone know anything about the full EU filing and approval process? With an FDA filing we know you have to first complete Phase 3"s then file. Perhaps the process is different for EU especially with an FDA approval already in hand, that is a shorter process or use of info from US studies as part of concurrent EU studies? Seems to me if not, then we would need to know expected date of completion of phase 3's and then the time it will take to file and and lastly the normal response time. Hard to project anything without such information it would seem... Just my opinion... I don't have specific knowledge of the process, but I recall all the testing required for EU approval was performed during the last Phase III trial. All that is needed is a repackaging of the materials and once submitted its a 200+ days to approval or denial. Hope this helps. |
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Post by liane on Oct 19, 2014 17:27:28 GMT -5
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Post by mannmade on Oct 19, 2014 20:13:33 GMT -5
Think that answers it once we know the date of submission. Assuming product will be produced at Danbury for now.
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Post by mannmade on Oct 19, 2014 20:13:43 GMT -5
Thanks...
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Post by mnholdem on Oct 21, 2014 22:20:21 GMT -5
I knew about the 210 days, and posted about it, but I didn't see the extra 67 days stated in the document link above until now. An extra 2 months? In a word the mannmade is so fond of using... "Nuts!"
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Post by kc on Oct 21, 2014 22:40:57 GMT -5
Actually that is ok as it will allow for a smoother production from the Danbury plant. By the time of EU approval they might even have a European plant ready to go on line
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