References in periodicals archive ?
United Therapeutics expects to unblind and announce preliminary analysis of the FREEDOM-C study results in September 2011.
We look forward to continuing to work closely with the FDA as we unblind our phase III study later this year and prepare our NDA submission.
An independent data monitoring committee may well review both safety and efficacy data, it is very important that information that might unblind investigators or patients be restricted to the data monitoring committee and not released to any party involved in the conduct of the clinical trial.
After the database is locked, the Company will unblind the data, conduct statistical analyses, announce top-line results publicly and draft the clinical study report.
The Company expects to unblind data from this pivotal study in the fourth quarter, and plans to file a Pre-Market Approval (PMA) submission with the FDA by first quarter of 2011.
This significant milestone will allow us to unblind and analyze the data and report on it, with our expectation to file our regulatory submission in 2010.
While the DMC cannot release information on our closed session discussions, our recommendation to unblind this pivotal registration study in late-August is based on the status of the study, the defined safety profile over 8-years of this Phase 3 registration study and our review of the primary and secondary endpoint analyses.
Company Affirms Plans to Unblind and Report Fast Track Pivotal Phase 3 Results for SinuNase[TM] in March
The phase Ib study of Neu2000KL has completed enrollment and Amkor expects to unblind the data during the first quarter of 2008.
After recent communications with the FDA, the Company now expects to unblind EVEREST data and announce four-week primary endpoint results in January 2008, and to submit its pre-market approval application, or PMA, including 24-week secondary endpoint data and other outcome measures, early in the second quarter of 2008.
The STEP Study Oversight Committee, which is comprised of representatives from the three study co-sponsors, made the decision to unblind study volunteers following extensive discussion of the STEP results at last week's meeting of the HVTN by researchers, members of the community advisory boards of the study sites and other study site staff, including clinic coordinators and community educators.
As a result of this approach, we remain on track to unblind top line efficacy and biomarker data within the next several weeks and expect to release the results from the trial in this quarter.
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