Ann: Latest Patient Group Show Best Results to Date at 30 Days, page-55

Do you have any specific info on this, Eire, or is it just a guess?

In March Wayne said that they were still waiting on the Centers for Medicare Services to give the final approval for reimbursement, which probably wouldn't delay the study as it just pertains to getting paid for the DurAVRs used, and that 2 of the 7 sites had completed their ethics approvals. Those 2 were the Cleveland Clinic and Columbia University. That info made me think procedures should have been started by now but maybe there is some hang-up. This is probably the worst time to start a trial in the US as hospitals have generally faced staffing shortages and turnover both with medical personnel and with legal departments and study administrators.

One thing I noticed looking at the study details on clinicaltrials.org is that there are only 4 sites listed (including Cleveland and Columbia) but Methodist Debakey in Houston is not one of them even though Dr. Reardon is still listed as the Study Chair. The 4 sites listed are all top notch medical centers but not sure if the total participating institutions will be 4 reduced from 7 or if more will be added to the official study page.

I know from experience is that everything with the FDA and trials takes longer than expected but it would have been nice to have gotten more info on the EFS at the AGM beyond just hearing that 30 day data will be ready for the conference in October.