AT1 FY21 - General Discussion + FA, page-1785

Just attended the LDX AGM. No issues, went smoothly and no tricky Qs about FebriDx product (or about the Covidx de-prioritisation by FDA, strangely? in fact they just had a single Q in the entire AGM about FY21 ops vs FY22 plan ahead....weird)

Anyway, CEO confirmed that FebriDx approval discussions with US FDA are going fine. There was some delay in Q1 FY22 due to FDA resources being stretched with many Covid19 EUA approvals but these are now better. Company remains very confident of FDA approval in FY22 and has met all the approval requirements.

They have manufacturing setup, targeted sales campaign, product stockpile etc ready in anticipation of the approval & will begin staged rollout across US, approval. They plan to open with initial sales, then continue to expand after potential approval for gov $ reimbursements + will also engage with insurers, health bodies etc for early adoption of FebriDx in their processes.