It's only been given FDA approval for CSME, however it's not very economical for that procedure alone. Once it becomes approved for AMD especially, but also other diseases of the eye, then it will become very economical of course. Approval is just one step though, it will also require reimbursement (which the pivotal trial should be sufficient for).
Can't be certain about the timeline until the partnership is achieved, although approval should come quite fast as everything is ready to go. The trial design has been approved by the FDA and investigators from 18 leading medical institutions have agreed to participate. With the partnership itself, important to remember that in early 2022 (as mentioned in the first post in this thread) the company was targeting late 2023 to early 2024, so hopefully that means it's coming fairly soon.
Another thing is that it should start generating $$$ from the get go, as soon as the partnership is announced. It's planned that commercialisation in Europe will begin immediately with the assistance of the partner. They do have approval in this market, they just don't have the infrastructure yet to commercialise it there. That is likely adding to the complexity of the deal however, as the partner will need to be able to fund both that commercialisation and the trial as well
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- 2RT: A Groundbreaking Treatment for AMD (Major Partnership Deal Imminent)
2RT: A Groundbreaking Treatment for AMD (Major Partnership Deal Imminent), page-78
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