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Monday, February 24, 2014 10:36:31 AM
IMHO
1. If DCVAX-l does receive a DMC Halt for efficacy, what will transpire in all those German clinics?
I think the 21(?) German clinics prepared to open for the DCVAX-L trial would have almost instantaneous capacity to convert to compassionate use centers, and being that German approval for compassionate use reimbursement for the first year is nearly or equally equivalent to market approval, this could be very helpful revenue to complete EMA and FDA approval in addition to partially financing the ongoing DCVAX direct trial.
2. If the DMC instead rules on a continuance, the German clinics will surely open to increase enrollment and move NWBO toward full enrollment much more quickly. In the meantime, the eventual compassionate use reimbursement from the German Government will still help finance the DCVAX trials.
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