Ann: CelGro Nerve Repair AUS Regulatory Application Submitted, page-81

That July 2020 TGA submission seems a long time ago. COVID or not this application has taken far too long at the TGA. I'd flagged 4Q 2021 as my expectation - apologies for my optimism.

This company application has to be on the verge of TGA approval, in CelGro Nerve (Remplir).

The TGA's own website advises 90% of new applications being processed in 238 working days (we are around 380 excluding delays - the TGA stops the clock for consultations, etc.):

https://www.tga.gov.au/medical-device-application-processing-times

We've had the company confirm in the last quarter of 2021 from contact with the TGA, that it believes it meets the TGA requirements and is on track for approval:

"During the quarter, the Company progressed discussions with the TGA regarding its application for approval to supply Remplir™ in the Australian market for peripheral nerve repair. The Company believes its application meets the TGA’s requirements and is on track for approval.

Further, the Company is planning a submission for Remplir™ to be covered under private health insurance through inclusion on the Australian Department of Health’s Prosthesis List. In anticipation of market approval, the Company has commenced planning key opinion leader-led education and product awareness events designed to establish key accounts and attract a highquality distributor."

Just a little reminder what the stock did on the announcement of initial CelGro Nerve results back in May 2019:




I don't think we are going to get the jump in share price that we saw back then, but back to 50/60's surely very possible with approval (finally) of CelGro Nerve by the TGA (and then on to the FDA)?