Rae, no one wants an echo chamber full of confirmation bias and...

Rae, no one wants an echo chamber full of confirmation bias and appreciate your comments and views, but OCC had Striate approved by the FDA in January 2021 via the FDA 510K clearance route within 8 months of application during COVID times. It has been commercially available in global mkts for years, but crucially with BioHorizons for around a year now, and Henry Schein enthusiastically expanding to other business units. Punch www.biohorizons.com into your browser and Straite engulfs the browser page of one of the top global dental implant companies, front and centre.

Fiona Wood is going to have little to do with the approval of Remplir - she is a non-executive Director and will execute function therein. She will have much to do with the strategic drive of OCC and via her medical reputation add to the credibility of OCC and its products one hopes. But Remplir FDA approval application well under way and little to do with her - Australian commercial take up, for which its already TGA approved and in market she hopefully might influence.

OCC submitted its 510K animal study for Striate to the FDA in late May 2020. It was approved in Jan 2021 (this deep in COVID times you will recall). Apologies if I am stating the obvious, but Remplir essentially involves the same, already FDA approved, CelGro technology underlying Striate. OCC has repeatedly told us it will finish the latest specific FDA approval geared study by Jan-March 2024. Extrapolating from normal FDA approval times and OCC's history, I'd expect FDA approval by September at the latest, but possibly sooner. OCC is undeniably tardy in studies, but has actually done this type of study before in Remplir as I have reported in other threads:



Now OCC should have gone this route at least a year ago. That would be very criticism in my opinion. It messed around with US regulatory consultancy groups investigating other 'de novo' routes of approval that would have seen higher reimbursement rates (in part why Lesley Wise was recruited - a US reimbursement specialist) and arguably cost investors money (with an ailing share price) with the tardiness. But OCC's Remplir FDA approval pathway is already formally well underway with the FDA and Fiona Wood will have little influence on that - Remplir commercial take-up she hopefully will.