Hi Liverman,
I'm not aware of anything that has indicated that the full three years of the RCT data won't be required - suggests FDA application in Jan 2026 at the earliest. Happy of course to be positively surprised. No doubt there is regular communication between FDA and VTI.
The RCT is exactly like the Misight one, so we can expect an easy ride if no adverse events occur and results go as planned - lower risk than normal in my view.
Misight vs Naturalvue, page-18
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