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17:58
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Originally posted by synaphai:
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It'll take time because the trial design will need to be approved by the FDA, which shouldn't take long given that there won't likely be many changes from the EFS, but we'll need a lot more sites added beyond the 7 that participated in the EFS. Edwards is using 44 sites for its ongoing pivotal trial for their new Sapien version. That trial plans to enroll 915 patients and Wayne has said to expect maybe 900-1100 patients for our trial.
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Do we need to have all potential trial sites ready before the trial can begin or can we start from the 7 and add?
(20min delay)