US FDA regarding the US regulatory pathway for Remplir™, page-2

as per the half yearly

"The Company believe sits 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 high-quality distributor.The Company also continued to work closely with Veranex (previously Experien Group), as the Company’s US regulatory advisers, to evaluate opportunities for expedited approval of Remplir™ for nerve regeneration. The team commenced interactions with the US FDA regarding the appropriate US regulatory pathway, including the data required to support expedited review and reimbursement positioning."

the 24 month results should be complete around the end of June ( 21-6-21 was the 12 month )

current status
82.6% (19 of 23)of nerve repairs with Remplir™, at 24 months post treatment, resulted in functional recovery of muscles controlled by the repaired nerve.

celgro received TGA approval on 23-12-20 and FDA approval on 14 -1-21
but they mentioned they were expecting FDA approval coming in the TGA announcement

i would be surprised if it was that quick as nothing is quick with Biotec