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Monday, June 10, 2019 1:52:23 PM
“Plaintiffs' additional argument that Defendants were trying to "bury" interim efficacy results is undercut by the record itself. A review of the record in its entirety leaves as the only reasonable inference that the data monitoring committee had reviewed only safety data from the Phase III trials, not efficacy data. ECF No. 22 at 34 ("We had a safety-only evaluation . . . by the Data Safety Monitoring Committee"): 35 ("Up to now. the assessments have only been safety, so this will be the first assessment for efficacy"). Plaintiffs do not establish how Defendants deliberately withheld or concealed information with respect to the interim review.
Accordingly. Plaintiffs" claims related to the Interim Analysis of the DCVax-L Phase III Trial by the DSMB are dismissed.”
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