My notes from the webinar:- we have deep defence ties
- No US Tarrif impact expected.
- AU has Trade Deficit with USA.- No imopact as most the staff has been retained by FDA
- Effect of DOGE on FDA efficiency and approvals:
- Regular and Positive interactions with FDA
- Our Lead Reviewer remains teh same at FDA
- US approval ETA for Remplir remians on track for Mar/Apr 2025- 9% CAGR of quarterly revenue since launch of Remplir
- 3 Consecutive qurters if record revenue
- Crendentialed board with ties and experience in US market
- Tendon product SmartGraft scaffold) expected to launch in AU in CY25
- 127% revenue growth in AU from FY 23($457k) to FY24($1.04M)
- REMPLIR
- US TAM: USD$1.6B
- 700,000 nerve repair surgerical procedure done in US annualy. Most are suturing and 55% of them are unsuccessful.- US: Q1 25
- Expected REMPLIR Approvals
applications already submitted)
- Thailand: Q3 25
- Canada: Q4 25
*Total TAM (markets planned to enter): U$3.5B
Aim to achieve at least 20% i.e. U$700k or AUD$1B
**No questions taken.
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Open | High | Low | Value | Volume |
$1.22 | $1.24 | $1.20 | $737.4K | 608.7K |
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No. | Vol. | Price($) |
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1 | 9999 | $1.21 |
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Price($) | Vol. | No. |
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14 | 110398 | 1.200 |
2 | 10794 | 1.195 |
9 | 49980 | 1.190 |
2 | 1687 | 1.185 |
Price($) | Vol. | No. |
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1.215 | 17546 | 1 |
1.225 | 3282 | 1 |
1.230 | 16282 | 3 |
1.235 | 5000 | 1 |
1.240 | 34786 | 2 |
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