That's correct. The EFS is probably analogous to phase 1, with a small patient population and focus on safety, and the full pivotal trial is equivalent to a phase 3.
I'm not sure exactly how many patients we expect to enroll in the EFS but Wayne said in the interview I posted above that he expects to have results from 25-30 patients by the end of the year including both EFS and Georgia patients. FDA stuff usually takes longer than expected so I think it's probably a good idea to add some time to his projections. One thing I've found is that companies don't immediately get meetings with the FDA after they've ticked boxes, it may take time to get slotted in the FDA's busy schedule.
Once the EFS is done, and provided there are no problems with the trial, Anteris will consult with the FDA on the pivotal trial design and may enroll hundreds to thousands of patients in the trial, and in my experience enrollment also usually takes longer than expected. The Edwards Sapien pivotal trial enrolled 1000 patients in the TAVR arm with 780 completing it. Another 1000 SAVR patients were the control arm. The Medtronic Corevalve pivotal trial enrolled 1000 TAVR patients and 660 finished. We'll eventually see if we need those numbers or will be able to gather enough data with fewer patients.
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