Even more important than the 9th unblinding will be the safety data analysis due out in the 4th quarter:
"With respect to our LibiGel Phase III safety study, in February 2012, we announced that based upon the eighth unblinded review of safety data from the safety study by the study’s independent data monitoring committee (DMC), the DMC unanimously recommended continuing the safety study as described in the FDA-agreed study protocol, with no modifications. At the time of such announcement, 3,656 subjects were enrolled in the safety study resulting in over 5,800 subject-years of exposure. We anticipate that the DMC will perform another unblinded review of safety data from the safety study during the third quarter of 2012. Currently, we anticipate that top-line safety data of the safety study on an unblinded basis will be available during the fourth quarter of 2012."
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