Spectral Medical Inc T.EDT

Approval timing..

[SMlachake]

Anyone aware of any historical data as to how long it takes for a device approval once it acquires Breakthough designation? For this designation, plenty of data must have already been reviewed. And the device is approved in jurisdictions with similar standard of Healthcare Japan, Europe and Canada. It's just a matter of time.

[mercedesman]

The short answer is, it gets approved when the Trial is over (after sufficient enrollment). However there is more to it than that... 100 patients come from Euphrates (Phase 3)  150 come from Tigris (Phase 3b) Kellum says we are approachigin 1/3 enrollment for Tigris (that's 50 on my calculator) So 150 enrolled /250 needed = 60% complete. There will be an Interim Review at 90 patients

[SMlachake]

Thank you. That was a detailed answer. If my assumptions are correct, it only takes a few hours to collect data per patient which the FDA is eagerly waiting to process. So the only delay is participants and unfortunately there is never a shortage of patients. I now see why this could be complete any day. Great.