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Post by mnholdem on Feb 27, 2015 10:28:00 GMT -5
Perhaps we should be thinking of the European delay this way: How long will it take Sanofi to build a production facility in France to manufacture & supply Afrezza to Europe? Even if they have to use Amphastar's insulin for a while, a European plant would save freight expenses you'd get if you have to ship from the USA.
Last I heard, it will take approximately one year lead time from when the equipment is ordered to getting the lines certified (I assume EMA has the equivalent of CMC certification).
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Post by nemzter on Feb 27, 2015 10:33:26 GMT -5
SNY has been fairly quiet, even on providing details on when or if they even filed EU submission.
It wouldn't surprise me now if we were to actually see an EU approval for 'frezz before the end of this year.
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Post by mannmade on Feb 27, 2015 10:52:56 GMT -5
SNY has been fairly quiet, even on providing details on when or if they even filed EU submission. It wouldn't surprise me now if we were to actually see an EU approval for 'frezz before the end of this year. Not sure about that as it is my understanding they are in Phase 3 trials (or their equivalents) in EU right now. Bam not sure when they end but also my understanding it generally takes about 240 days from EUbfor a decision from date of submission. I don't recall where I saw above info but this is my current understanding
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Post by mnholdem on Feb 27, 2015 11:15:57 GMT -5
That's correct. Liane posted the timeline once to correct me when I wrote 210 days maximum. It's 210 max to go to the committee. Then they have it for about another 30 days and decide whether to approve or not.
About that word "maximum", I've wondered if it's possible that a company like Sanofi can influence the EMEA/EMA to streamline the approval process for Afrezza, perhaps in much less time than the maximum of 240 days.
After all, we're talking about an active pharmaceutic ingredient (human insulin) that has been around for a long time.
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Post by otherottawaguy on Feb 27, 2015 12:22:21 GMT -5
I went sniffing around at the EMA website. No mention of Afrezza nor Mannkind. Found a couple of cherries about Exubera.
OOG
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