While I believe mid calendar 2025 is a possibility – with...

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:

1.    Further tweaking of the AI algorithms with Stage 2 trial data
2.    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)
3.    Further tweaking of the AI model with results of the Stage 3 trial
4.    Continuing preparations for pre-submission meeting with FDA
5.    Validation Trial design
6.    FDA review of the Validation Trial design
7.    Meeting with FDA to discuss Validation Trial design
8.    Finalisation of Validation Trial design
9.    Commencement of recruitment for Validation Trial (noting that numbers are still unknown)
10.    Completion of Validation Trial
11.    Assessment of Validation Trial outcomes
12.    Preparation of de Novo market clearance application
13.    Submission of de Novo application
14.    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)
15.   Scaling up production capacity
16.   Negotiating distributional agreement and commercial terms

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.