Post by mnholdem on Aug 23, 2015 9:56:47 GMT -5
The subject of current EU trials for Afrezza has dominated some threads as of late, but we forget that several Afrezza trials were being conducted in Europe around the time the FDA hit MannKind with it's 2nd CRL a few years back. Does that mean the European trials were halted? Find out for yourself. Here is a link to the EU Clinical Trials Register.
www.clinicaltrialsregister.eu/ctr-search/search?query=Inhaled+insulin+human
Please note that the EMA cannot show summary trial results at this time because of a software issue, as explained upon entrance to the coinical trials site:
"News update
"An error has been identified in the software used to load summaries of results into the EU Clinical Trial Register (EU CTR). The problem may affect a subset of results which have been processed outside of the system and reloaded. As a precautionary measure, all summary results of clinical trials in EU CTR are currently being reviewed. During the review, the summary results will be temporarily unavailable, and you will see the text “Trial results: Removed from public view” when you click on the clinical trial summary in EU CTR. The summary results will be gradually made available for public access again, once the information has been reviewed and verified.
"In addition, the access for sponsors to enter results or edit existing results has been blocked (and no new accounts are being issued) whilst the underlying software error that gave rise to the problem is resolved. This incident does not affect the “Paediatric studies in scope of Art45 of the Paediatric Regulation”.
"Please click here to continue to the site?"
www.clinicaltrialsregister.eu/ctr-search/search?query=Inhaled+insulin+human
Please note that the EMA cannot show summary trial results at this time because of a software issue, as explained upon entrance to the coinical trials site:
"News update
"An error has been identified in the software used to load summaries of results into the EU Clinical Trial Register (EU CTR). The problem may affect a subset of results which have been processed outside of the system and reloaded. As a precautionary measure, all summary results of clinical trials in EU CTR are currently being reviewed. During the review, the summary results will be temporarily unavailable, and you will see the text “Trial results: Removed from public view” when you click on the clinical trial summary in EU CTR. The summary results will be gradually made available for public access again, once the information has been reviewed and verified.
"In addition, the access for sponsors to enter results or edit existing results has been blocked (and no new accounts are being issued) whilst the underlying software error that gave rise to the problem is resolved. This incident does not affect the “Paediatric studies in scope of Art45 of the Paediatric Regulation”.
"Please click here to continue to the site?"