While I believe mid calendar 2025 is a possibility – with perfect execution and no hold-ups on the part of FDA – I think late calendar 2025 or some time in calendar 2026 is more likely.
We still have the following processes to work through:
My take is that if Emvision can get FDA support for a streamlined Validation Trial (that is much shorter than pre-validation Stages 1, 2 and 3) and if it can secure a streamlined De Novo application assessment significantly less than the average (say maximum of 150 days), then it could be taking EMU to market mid-2025. If those things don’t eventuate, market entry will be some time later.
- Further tweaking of the AI algorithms with Stage 2 trial data
- Continuing recruitment of Stage 3 haemorrhagic stroke patients (30) which should continue for a couple more months at least (given that it took more than 6 months, with all 3 centres operating, to recruit 18 haemorrhagic stroke patients in Stage 2)
- Further tweaking of the AI model with results of the Stage 3 trial
- Continuing preparations for pre-submission meeting with FDA
- Validation Trial design
- FDA review of the Validation Trial design
- Meeting with FDA to discuss Validation Trial design
- Finalisation of Validation Trial design
- Commencement of recruitment for Validation Trial (noting that numbers are still unknown)
- Completion of Validation Trial
- Assessment of Validation Trial outcomes
- Preparation of de Novo market clearance application
- Submission of de Novo application
- FDA assessment of application (noting that the mean decision time for the 374 De Novo requests from 1997 to Aug 2023 was 338 days – with a range from 28 days to 900 days)
- Scaling up production capacity
- Negotiating distributional agreement and commercial terms
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- Ann: Quarterly Activities/Appendix 4C Cash Flow Report
Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-11
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