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Zur Info. 12.1.2016
Zoptrex?
The ZoptEC study will conclude upon the occurrence of approximately 384 events, which we expect to occur by September 2016
Macrilen?
We expect to complete the confirmatory Phase 3 clinical trial by the end of 2016.
http://secfilings.nasdaq.com/...NC.&FormType=F-10/A&View=html
30.3.2016 Zoptrex TM We expect to complete the ZoptEC trial during the third quarter of 2016 and, if the results of the trial warrant doing so, to file the NDA for Zoptrex? in 2017, looking toward commercial launch of the product in 2018, assuming positive Phase 3 results and that our NDA is granted. Macrilen ? We currently estimate that the trials will be completed in Q3 of 2016, with a combined expected expenditure of approximately $5 million over the remaining trial period. This would permit us to submit a NDA by mid-year 2017. If the study is successful in meeting its primary endpoint, we anticipate FDA approval of Macrilen? by year-end 2017. http://secfilings.nasdaq.com/...20INC.&FormType=6-K&View=html
und noch mal 30.3.2016 Zoptrex? We expect to complete the ZoptEC trial in the third quarter of 2016 and, if the results of the trial warrant doing so, to file a new drug application ("NDA") in the United States for Zoptrex? in 2017. We are now moving forward with our planning to commercialize Zoptrex?, looking toward commercial launch of the product in 2018, assuming positive Phase 3 results and that the NDA is granted. Macrilen? Based on the current rate of enrollment, we expect the confirmatory Phase 3 clinical study of Macrilen? to be concluded in the third quarter of 2016. Furthermore, we expect to be able to submit an NDA for Macrilen? to the FDA by mid-year 2017 and, if the study is successful in meeting its primary endpoint, to obtain approval of the drug by year-end 2017. http://secfilings.nasdaq.com/...0INC.&FormType=20-F&View=html
1.4.2016 Zoptrex? The ZoptEC study will conclude upon the occurrence of approximately 384 events, which we expect to occur by September 2016. After the conclusion of the study, the data obtained will be analyzed and we will make a decision regarding the likelihood that the Food and Drug Administration ("FDA") will approve the compound for its indication. If we conclude that there is a reasonable likelihood of approval, we will prepare and file a New Drug Application ("NDA") seeking approval of the compound for its indication. The FDA typically requires one year to make a decision on the approvability of an NDA. Macrilen? Because the Phase 3 clinical trial of Macrilen? is a confirmatory trial, the FDA will make a decision regarding the approvability of Macrilen? within approximately six months of the date we file the NDA. We expect to be able to submit an NDA for Macrilen? to the FDA by mid-year 2017 and, if the study is successful in meeting its primary endpoint, to obtain approval of the drug by year-end 2017. http://secfilings.nasdaq.com/...INC.&FormType=424B5&View=html
Habe es schon nach 5 St. gefunden!!!!!! :-)
Ergomed. Under the terms of the agreement, Ergomed has agreed to assume 30% (up to $10 million) of the clinical and regulatory costs for ZoptEC, which are estimated at approximately $32.5 million. Ergomed will receive 22its return on investment based on an agreed single-digit percentage of any net income or net proceeds from licensing activity we receive for Zoptrex? in this indication, up to a specified maximum amount. http://secfilings.nasdaq.com/...0INC.&FormType=20-F&View=html
Sollte nicht vergessen werden bei der Berechnung.
Carvin , Gropius.!...................CAAARVIN , GROOOOPIUS!!!!! ........ SIND WEG!
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