"Prior to submitting a De Novo request to the FDA, we recommend you consider submitting a pre-submission to obtain feedback from the appropriate premarket review division." thats what the FDA say.
Once we receive feedback then FDA de novo can be prepared and submitted. Should take a further 6 months at least for the approval to go through? I think it will look like early 2021.
Also the Qtrly for March last year came out end of April, so we might be 2 weeks away from that.
"Prior to submitting a De Novo request to the FDA, we recommend...
Add PCK (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
2.8¢ |
Change
-0.002(6.67%) |
Mkt cap ! $45.84M | |||
| Open | High | Low | Value | Volume |
| 2.9¢ | 2.9¢ | 2.8¢ | $7.462K | 257.5K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 5 | 1209083 | 2.8¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| 2.9¢ | 60000 | 1 |
View Market Depth
| Last trade - 14.48pm 18/11/2024 (20 minute delay) ? |
| PCK (ASX) Chart |