Media thread, page-155

?? Remplir shouldn't need Phase 3 trials? Its pretty much a shoo-in on the 510K route already, per CelGro Bone (Striate) approval with the FDA. The company and consultancy are no doubt negotiating with the FDA about a more lucrative application route than that, without the need for further studies, particularly give TGA approval.

Some might speculate that with the final 24 month results of all patients in the nerve regeneration study "on track for Q2 CY2022", that given the company's strategic change and resulting delay with Remplir and the FDA (by foregoing 510K route), they might be using that data for a more lucrative and yet still swift market entry with the FDA:

https://www.greenlight.guru/blog/fda-pathways-medical-device-to-market

(I wouldn't dare speculate, I might be accused of ramping, but connecting the dots....)