So correct me if I have misunderstood the current situation for the Invivage FDA approval.
Sometime before June, a decision will be made on the type of clinical study (or studies) that will be undertaken no doubt starting sometime in late 24. Once those studies are completed, the FDA application can be submitted and the 6-9 month waiting begins. If successful, the approval will be given. What are people's projections for this? Well, we have no idea on the length or number of studies to be undertaken. Best case? I can't see it being calendar 2025.
Ann: OIL March 2024 Quarterly Report and Appendix 4C, page-2
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