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Likewise, those who unblind studies, drop out, alter dosages, and take off-protocol drugs threaten to harm their fellow research subjects by altering the risk-benefit ratio of the study.
We expect to unblind data from this study sometime during the first half of 2011.
By comparing study experiences, they can influence other participants' behavior and may also inadvertently unblind a study by enabling their peers to determine whether they are receiving the investigational drug or a placebo.
0015 for the primary endpoint, time to disease progression - Celgene will unblind the studies and allow all patients in these studies access to REVLIMID - Discussions with FDA and international regulatory agencies are ongoing - Plans being formulated to create expanded access programs for patients with previously treated myeloma
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.
The Company expects to complete enrollment in its ongoing pivotal global Phase 3 trial in second-line soft tissue sarcoma by the end of 2015 and unblind the clinical data by mid-2016.
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.
CTI BioPharma expects to unblind and report top-line data from the PERSIST-1 pivotal Phase 3 trial of pacritinib for patients with myelofibrosis late in the first quarter of 2015.
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.
The Company plans to unblind the study and report topline data in March 2015.
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 trial was halted well short of the planned enrollment, the Company elected to unblind the data and present the results on behalf of the study investigators.
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