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
- Forums
- ASX - By Stock
- Ann: Quarterly Activities/Appendix 4C Cash Flow Report
While I believe mid calendar 2025 is a possibility – with...
-
- There are more pages in this discussion • 1 more message in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add EMV (ASX) to my watchlist
|
|||||
Last
$2.24 |
Change
0.050(2.28%) |
Mkt cap ! $191.3M |
Open | High | Low | Value | Volume |
$2.19 | $2.28 | $2.09 | $114.3K | 52.03K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 1995 | $2.24 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$2.33 | 505 | 1 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 1995 | 2.240 |
1 | 2500 | 2.230 |
1 | 1010 | 2.190 |
1 | 2911 | 2.150 |
1 | 2549 | 2.040 |
Price($) | Vol. | No. |
---|---|---|
2.330 | 505 | 1 |
2.350 | 15000 | 1 |
2.390 | 2000 | 1 |
2.400 | 1200 | 1 |
2.580 | 4600 | 1 |
Last trade - 16.10pm 25/06/2024 (20 minute delay) ? |
Featured News
EMV (ASX) Chart |