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davidal66

02/18/17 6:22 PM

#623 RE: Oren1976 #622

Sorry, I just don't follow your logic on this one. I'm right on my last post, maybe you're right and they botched the phase III trial design; who knows, but I honestly don't think so. As to your argument about limiting Avastin in the phase III trial design; how would that work since it's an FDA approved therapy? Actually the only FDA approved therapy in rGBM.

The more important cohort that closely models the phase III trial design is the continuous cohort, which allows the patent to continue with avastin/VB-111 on progression with VB-111. The more important point I keep returning to is this: is the 15 month overall survival spurious. If so, how is it spurious. That's all that matters to me on the VB-111 story. You've got animal data backing up the hypothesis that VB-111 and also signals of efficacy in three different cancer conditions.

This is the only critique that matters; was the continuous arm cohort flawed, spurious. I saw some on twitter... top biotech names claiming the continuous arm cohort had longer survival/responses because they received more Avastin! Of course they received more Avastin, but Avastin shouldn't alone lead to 15 month overall survival in rGBM.

If your interested, listen again to the PI of the trial, Dr. Chl. discuss these very facts in the KOL presentation from last year. He discusses these very points in more detail on why/what could have caused the 15 month overall survival in the continuous cohort. He explains it better than moi.