Ann: Regulatory Approval for Remplir Nerve Repair Device, page-94

Given I am so often called a ramper, I might take the opportunity to point out that OCC had a Straite (CelGro Bone) 510K application in with the FDA at the time Rossi. We don't with Remplir (CelGro Nerve) so the comparison not really valid. The company deciding to go discuss more lucrative avenues with the FDA, rather than taking the 510K route, which would have seen them a shoo-in.

That said we are well overdue an update on Remplir and I am hoping for some sort of fast track denomination by the FDA, given the previous FDA approval of Straite, recent TGA approval and clearly demonstrated life changing success OCC has shown with CelGro Nerve in Paraplegics. Paradigm got fast track denomination in its arthritis injectable application recently. I'd say Remplir is morally, procedurally and ethically even more convincing a candidate, particularly with it being FDA approved as a bone repair device already.