Ann: Strategic Placement to Raise $3.5 million, page-83

They will likely finish the Remplir study in terms of 24 week physical study in late Q1 2024 - and presumably will update the mkt as such - and then collate all the data and results for final results to release in full to market in Q3 2024 and then take to the FDA likely in Q4 2024 - I know it all seems tardy for a simple 510K application.

The nerve repair study for US regulatory approval is a comparator study (almost exactly like they did in Striate for the FDA 510K approval).

"The study provides information regarding mechanism of action that is not possible to collect in human clinical trials. The outcomes from the study will support product marketing initiatives and international regulatory approval and reimbursement strategies for Remplir."

Its basically conducted by Professor Bill Walsh, Director of Surgical and Orthopaedic Research Laboratories (SORL) at the Prince of Wales Hospital in Sydney and the University of New South Wales. Basically 72 rats across 3 study groups across 4,8 and 24 week intervals - basically dissecting them to see progression of nerve repairs using Remplir and the comparable product in market. Basically what it did before in Striate for FDA approval, just in a different form of tissue regeneration.

They then go to the FDA with it (and presumably a load of other data including the 85% sunctional success in human nerve repairs). The last timeline update in the Singapore release:

"US approvals process progressing according to plan with the Remplir US 510k regulatory study on track for completion and data read out in Q3 CY24, with US regulatory application on track for submission in Q4 CY24 and approval expected shortly thereafter."

(formal study announcement here)
https://announcements.asx.com.au/asxpdf/20230418/pdf/45nrb73d7lfy6d.pdf

(this should have all happened a year ago IMO, but they dawdled with exploring "de novo" routes with a US consultancy to the FDA, and higher remuneration, and then went back to the original 510K plan - that was a stretegic error/delay by both the board and executive management team in my opinion, but we are getting there at last).