Just asking how many tests are needed for De Novo clearance.My understanding was over 300 tests but maybe that was for earlier tests in Australia. Assuming that a 6th Hospital is selected by June 30 and other tests are already underway, would it be reasonable to expect results between 1/1 - 30/6/26. That’s not long, but I still expect a big whale to swallow us up in due course.
Ann: Additional Pivotal Trial Site Activations, page-15
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