?? Remplir shouldn't need Phase 3 trials? Its pretty much a shoo-in on the 510K route already, per CelGro Bone (Striate) approval with the FDA. The company and consultancy are no doubt negotiating with the FDA about a more lucrative application route than that, without the need for further studies, particularly give TGA approval.
Some might speculate that with the final 24 month results of all patients in the nerve regeneration study "on track for Q2 CY2022", that given the company's strategic change and resulting delay with Remplir and the FDA (by foregoing 510K route), they might be using that data for a more lucrative and yet still swift market entry with the FDA:
https://www.greenlight.guru/blog/fda-pathways-medical-device-to-market
(I wouldn't dare speculate, I might be accused of ramping, but connecting the dots....)
- Forums
- ASX - By Stock
- Media thread
?? Remplir shouldn't need Phase 3 trials? Its pretty much a...
-
- There are more pages in this discussion • 475 more messages 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 OCC (ASX) to my watchlist
(20min delay)
|
|||||
Last
44.5¢ |
Change
-0.015(3.26%) |
Mkt cap ! $93.26M |
Open | High | Low | Value | Volume |
45.0¢ | 46.0¢ | 44.5¢ | $104.8K | 233.3K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 2000 | 44.5¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
45.0¢ | 5000 | 1 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 2000 | 0.445 |
3 | 85159 | 0.440 |
1 | 500 | 0.435 |
2 | 19005 | 0.430 |
1 | 40000 | 0.425 |
Price($) | Vol. | No. |
---|---|---|
0.450 | 5000 | 1 |
0.460 | 45135 | 4 |
0.465 | 14040 | 2 |
0.470 | 40287 | 5 |
0.475 | 5000 | 1 |
Last trade - 16.10pm 18/09/2024 (20 minute delay) ? |
Featured News
OCC (ASX) Chart |