Diamondjim61,
Those you have listened to seem to be in line with the hard line bears about trial set up and regulator final determinations. I assume they are well versed on the changing attitudes of regulators and have taken into consideration the sense of national pride the Germans have with regard to their part in this technology. Believe me, the Germans have no intention of being left behind with regard to this technology. Regulators have slowly been working on pathways that create greater flexibility to establish validation and improve patient access to newer treatments. Part of the delay in unblinding may have to do with waiting on gaining access to these newer provisions though I hope not because that would mean extreme financial hardship for NWBO to benefit. I would also hope that the long tail data currently available would be more than sufficient evidence for efficacy and proof of improving outcomes being seen in the last group of patients enrolled. Dr. Linda Liau intoned a hope for the DCVax-L Phase 3 back in 2015 when she said that there ought to be a way for this trial to find a pathway for approval if efficacy is determined outside of measurements that might otherwise be considered inadequate in terms of measuring long term benefit for a large portion of a patient population. I believe part of the reason she is being honored with multiple accolades this year, besides for all her research, is her part in helping regulators understand the changes needed to adequately assess immunotherapy activity and benefit from a clinical perspective. Best wishes.
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