As they are using DeNovo process after working with FDA for IDE and endpoint requirements, I have little doubt it will go through. This is not a PMA which is a heavy duty approval process. Sometimes, additional information may be requested by FDA which can slow the process by 1-3 months.
They previously had a EU CE-Mark quality system in place and this will de-risk getting any unexpected basic documentation issues.
As they are using DeNovo process after working with FDA for IDE...
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Mkt cap ! $5.824M | |||
| Open | High | Low | Value | Volume |
| 0.2¢ | 0.2¢ | 0.2¢ | $4.303K | 2.151M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 27 | 40085905 | 0.1¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| 0.2¢ | 91807222 | 63 |
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| Last trade - 10.57am 04/12/2024 (20 minute delay) ? |
| AXP (ASX) Chart |
