Like everyone here, I would be absolutely ecstatic if we could get an approval based on the FIH and EFS studies but I don't think there's any conceivable chance that will happen.
Edwards is running a 915 patient trial to get the updated version of its Sapien device approved and it's a revised version of an already approved valve. No way will the FDA let a novel valve take a shortcut.
The number 1 priority of the FDA is safety and these are life-sustaining devices so they are expected to show that they are safe by completing sufficiently powered trials, which require large patient populations.
Like everyone here, I would be absolutely ecstatic if we could...
Add to My Watchlist
What is My Watchlist?
 (20min delay)
|
|||||
|
Last
$6.00 |
Change
-0.030(0.50%) |
Mkt cap ! $92.99M | |||
| Open | High | Low | Value | Volume |
| $6.01 | $6.03 | $5.84 | $85.53K | 14.32K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 333 | $6.00 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $6.25 | 1000 | 1 |
View Market Depth
| Last trade - 16.10pm 23/06/2025 (20 minute delay) ? |
| AVR (ASX) Chart |