Well, let's get back to the basics
IMO it's not unreasonable for FDA to ask questions, but the key to whether FDA will reject it lies with:
1) Is it safe
2) Is there potential to show efficacy
Admittedly clinical data available to date are from small trials - not dissimilar to SRX.
1) In the limited dataset, the device appeared to be safe
2) The studies also showed potential for efficacy, one of the studies showed OS ~10mths vs ~5
The mechanism of action is simple, if there is a hiccup with approval it's probably due to paper work rather than the device not working. Note that I'm not ruling out the potential for a hiccup hence my hold sentiment
Add to My Watchlist
What is My Watchlist?
 (20min delay)
|
|||||
|
Last
$1.11 |
Change
0.025(2.30%) |
Mkt cap ! $20.51M | |||
| Open | High | Low | Value | Volume |
| $1.09 | $1.11 | $1.09 | $26.73K | 24.35K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 6807 | $1.11 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.12 | 6617 | 1 |
View Market Depth
| Last trade - 16.10pm 07/08/2025 (20 minute delay) ? |
| OSL (ASX) Chart |