Just their usual specious sandbagging.
Despite the FDA providing preliminary feedback 18 months ago... where Painchek clearly advised the market they will review and agree on any additional clinical data required for the De Novo submission. Which may require a clinical trial in the USA.
PD's comments on the prelim feedback.
“We are pleased with this preliminary response as the FDA recognise PainChekTM as a novel medical device and we have experience of this process. The added benefits of conducting clinical trials in the USA, prior to commercial launch, includes engaging with major potential clients at an early stage that can accelerate the overall market development in the USA” commented Philip Daffas CEO PainChek Ltd.
Just their usual specious sandbagging. Despite the FDA providing...
Add PCK (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
3.1¢ |
Change
0.001(3.33%) |
Mkt cap ! $50.71M | |||
| Open | High | Low | Value | Volume |
| 3.0¢ | 3.1¢ | 2.9¢ | $39.10K | 1.271M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 4 | 957373 | 2.9¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| 3.1¢ | 175237 | 1 |
View Market Depth
| Last trade - 16.10pm 26/04/2024 (20 minute delay) ? |
|
|||||
|
Last
3.1¢ |
Change
0.001 ( 3.33 %) |
||||
| Open | High | Low | Volume | ||
| 3.1¢ | 3.1¢ | 2.9¢ | 76478 | ||
| Last updated 11.56am 26/04/2024 ? | |||||
| PCK (ASX) Chart |