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Re: AVII77 post# 232619

Monday, 06/10/2019 7:18:37 PM

Monday, June 10, 2019 7:18:37 PM

Post# of 689198

“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.


In addition, not only does the red text from the court ruling show the 2015 interim was an efficacy interim .....

....the bolded blue text shows that "the interim review" the judge ruled on was not the 2015 interim.

How could the judge rule about withholding information from an interim that had not yet occurred?

Again, the lawsuit dealt with the 2013 interim.

It was silent on the 2015 interim (except quoting NWBO as saying it was planned in the future and would be an assessment of efficacy, importantly for the lawsuit, the first assessment of efficacy)
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