At the NWR Conference in late March, Wayne said the pivotal trial will enroll 500-1100 patients and that he expects it to be enrolled in a year. That would mean the trial will take 2 years since each patient will be followed for a year. He also said that the company will be reimbursed $25,000 USD for each DurAVR used in the trial so that will obviously offset the cost by $12.5 million to $27.5 million depending on the number of patients enrolled.
He hasn't given any guidance on the number of sites for the pivotal trial that I can remember but I expect more than 20.
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