confirmatory trial

confirmatory trial

A Phase-3 clinical trial during which the previously revealed actions of a therapeutic intervention are confirmed.
References in periodicals archive ?
By extinguishing these Series B Warrants and with our upcoming share consolidation, we anticipate an improved capital structure that will provide the necessary basis to successfully build shareholder value as we proceed toward the completion of our pivotal, phase 3 program for Zoptrex, which recently received the DSMB recommendation to proceed to completion, as well as the completion of the confirmatory trial for Macrilen and, our anticipated continued increase in revenue contribution from our current and anticipated additional commercial activities.
By extinguishing these Series B Warrants and with our upcoming share consolidation, we anticipate an improved capital structure that will provide the necessary basis to successfully build shareholder value as we proceed toward the completion of our pivotal, phase 3 program for Zoptrex(TM), which recently received the DSMB recommendation to proceed to completion, as well as the completion of the confirmatory trial for Macrilen(TM) and, our anticipated continued increase in revenue contribution from our current and anticipated additional commercial activities.
It is important to note that this journey continues through the completion of our Phase 3 Translarna confirmatory trial in nmDMD (ACT DMD) which is a high priority for PTC and the DMD community.
A second, confirmatory trial evaluated tesetaxel as 1st-line chemotherapy for locally advanced or metastatic HER2-negative breast cancer (as described above).
However, a former MP alleged, in a letter to a Cabinet minister, that a third company with an Israeli partner was allowed to take part in a confirmatory trial.
It was also felt that regulatory bodies could consider positive results from VOICE as a possible confirmatory trial of CAPRISA 004.
ADPnews) - May 4, 2011 - Austrian vaccine maker Intercell AG (WBAG:ICLL) announced today the start of a confirmatory trial in the field of pandemic influenza for the investigation of its adjuvant patch -- Vaccine Enhancement Patch (VEP).
We have begun to accelerate the efforts to conduct a Phase III Confirmatory Trial for Cintredekin Besudotox, IL-13-PE38, for the Treatment of Recurrent Glioblastoma Multiforme.
Within the next six weeks, Ortec expects to complete the confirmatory trial designed to confirm the superiority of cryopreserved OrCel in the treatment of difficult-to-heal venous leg ulcers in comparison to the standard of care therapy.
As previously reported, we expect that this publication will help to underpin our commercial activities with Celacade in the European Union, where it has already been approved, as well as the initiation of the ACCLAIM-II trial, our confirmatory trial in NYHA Class II patients being planned for the purpose of achieving regulatory approval in the United States.
Officials at AtheroGenics indicated that they plan to back a large confirmatory trial.
Building on that foundation, we will continue our work with the FDA on this confirmatory trial.