The Company has now engaged Experien Group as its US regulatory advisory team to evaluate opportunities for expedited approval of CelGro® for nerve regeneration. The evaluation has been completed and Experien is now developing the US FDA submission to confirm the most appropriate US regulatory pathway, which includes potential for inclusion in expedited programs and clarity regarding the reimbursement value of the product.
FDA lodgment not far away for Nerve and we should get approval with the TGA fingers crossed by christmas.
Revenues from Dental and Nerve should boom post USA launch and partnership, off a low base but the profit margins are huge as we know.
Ann: OCC Secures Patents for Suture-Less Repair of Soft Tissue, page-2
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