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Post by perrhann on Oct 25, 2015 22:19:33 GMT -5
Will someone please google, phase III trials afrezza uk. It appears there is more information if you have access to this site. Thank you, Perry.
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Post by peppy on Oct 26, 2015 5:14:42 GMT -5
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Post by perrhann on Oct 26, 2015 8:13:59 GMT -5
Thank you peppy, I've seen the web site but I don't know if it shows that approval for uk and ema have already been applied for and they are waiting for the trials information to approve or not. Also the page states that additional information is available for registered users, I did not know if someone might know a member. They are showing a release date of 2015 so I'm wondering if they think it will be available in Europe this year. Thank you very much.
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Post by mbseeking on Oct 26, 2015 8:30:01 GMT -5
Thank you peppy, I've seen the web site but I don't know if it shows that approval for uk and ema have already been applied for and they are waiting for the trials information to approve or not. Also the page states that additional information is available for registered users, I did not know if someone might know a member. They are showing a release date of 2015 so I'm wondering if they think it will be available in Europe this year. Thank you very much.
Agreed with teh two pieces of good news out since Friday (TASE, BOA) this would be a great find. So who knows someone with a NHS email id? |
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Post by peppy on Oct 26, 2015 8:30:22 GMT -5
Thank you peppy, I've seen the web site but I don't know if it shows that approval for uk and ema have already been applied for and they are waiting for the trials information to approve or not. Also the page states that additional information is available for registered users, I did not know if someone might know a member. They are showing a release date of 2015 so I'm wondering if they think it will be available in Europe this year. Thank you very much.
Here is my take and I barely know anything about what needs to be done for EU approval. I thought the "clamp studies", needed to be done, 1) for FDA after approval continuing study and 2) for European approval. www.clinicaltrials.gov/ct2/show/NCT02470637
This is the impression I have after reading posts on this board and some fda documents I have read. I may have it wrong. I hope the people on this board knowledgeable about this, tell us.
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Post by rrtzmd on Oct 26, 2015 10:19:54 GMT -5
Will someone please google, phase III trials afrezza uk. It appears there is more information if you have access to this site. Thank you, Perry.
There are no phase 3 trials currently using afrezza. The website you refer to, and which someone else has provided a link to, only indicates the stage at which afrezza currently exists in the UK. In other words, it hasn't been approved and they are waiting for submission of the phase 3 data there. Once Sanofi applies for approval by the EMA, the phase 3 data will be submitted to the "Committee for Medicinal Products for Human Use," which will evaluate the data and make recommendations to the EMA. Once that has happened, it will be published by the EMA here: pending EC decisions |
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