1. A tremendous amount of difficult work during the quarter made this successful turn-around possible. We now have the resources to complete the Phase 3 studies of both Zoptrex™ and Macrilen™ and to move the Company to an entirely new level, if our confidence in our product candidates is demonstrated with positive outcomes of the clinical programs.
2.Commenting on the Company’s product-development progress, Mr. Dodd stated, “During the fourth quarter, we received very encouraging news regarding Zoptrex™ when, following a comprehensive review of the final interim efficacy and safety data, the DSMB recommended that we continue the ZoptEC Phase 3 clinical study to its conclusion. We expect to complete the ZoptEC trial in Q3 of 2016 and, if the results of the trial warrant doing so, to file the NDA for Zoptrex™ in the first half of 2017. More recently, we reported on the successful progress of the Zoptrex™ development program in China. We also initiated patient enrollment in our confirmatory Phase 3 clinical study of Macrilen™, which we expect to be the first FDA-approved test for the evaluation of adult growth hormone deficiency. We expect the confirmatory Phase 3 clinical study of Macrilen™ to be concluded in Q3 of 2016, which 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 as early as year-end 2017.”
Irgendwie scheint sich Dodd seiner Sache sehr sicher zu sein.
Er hegt keinen Zweifel an einer Zulassung !
Sind die Studienergebnisse so gut ?
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