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Saturday, December 21, 2013 12:41:28 PM
I do believe the trial could be halted/modified early in order to unblind it and give the control arm DCVax-L right away instead of waiting for progression in the control arm patients. While there is a cross-over arm, sometimes that is still too late. So, because DCVAX-L for GBM has orphan status, contrary to Cramer's ( he thinks it just gives some patent protection and market incentives) opinion, the FDA can lower their statistical powering requirements. This, plus the other improved techniques, booster shots and patients from 2008 could move the board to make an earlier decision. Here is another question I would ask at the upcoming January presentation, 'how does the cross-over arm affect statistical analysis of OS against the control arm?'
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