One other question for the hive mind. If the drug is successful for its phase 3 primary efficacy endpoint, do opthea plan to submit for FDA approval immediately, or will they need to wait a further 12 months for the safety data to come through?
I have read through all recent company announcements/reports and can't seem to find a lot of clarity on this. They are saying they think they are on track for a potential 2025 USA launch; but that could be June 23' enrollment complete, June 24' efficacy complete, June 25' safety complete, and then FDA/launch in very late 25 early 26. Vs an early 25 launch if they can file without all the safety data.
can anyone point me in the direction of any company commentary on this? I get the whole 'do your own research thing' so sorry to hassle, I'm trying but haven't found anything concrete just yet.
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