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Re: None

Monday, 05/25/2015 2:55:59 PM

Monday, May 25, 2015 2:55:59 PM

Post# of 700308
It appears there is some evidence from the Novocure EF14 randomized phase III trial that PFS under SOC is around 4 months. So DCVAX L would need a 100% PFS increase to reach significance (8 months vs 4 months if a similar PFS is found in their placebo group). Is this correct?

I also find it interesting that Novocure was able to enroll 700 patients for their phase 3 GBM trial from 2009 to 2014 as compared to NWBO.

Also, are there any negative consequences to DCVAX L if Novocure's treatment becomes the new SOC during the clinical trial? How would the FDA account for an improved SOC when reviewing NWBO's L trial data?
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