I better clarify the time frame further on EU approval process.
There are two parts:
In the case of ATL1103:
first part: approval in 10 days
A single application, submitted to the Clinical Trials Facilitation Group (CTFG) in English, is evaluated in a single procedure by the competent authorities of those Member States where the clinical trial is to be performed.
Clinical Trial Application (CTA) is submitted together with the required essential documents to each national Competent Authority (NCA) involved in the Voluntary Harmonisation Procedure (VHP) and approval should then be provided within 10 days (instead of the 60+ days for normal CTA approvals).
The second part is involved Ethical Committee (EC) review which may take a few weeks.
I am not sure if the trial can commence at least for recruitment and drug manufacturing while waiting for the EC review.
what a joke, page-78
-
- There are more pages in this discussion • 2 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Add PER (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
10.5¢ |
Change
0.000(0.00%) |
Mkt cap ! $94.66M | |||
| Open | High | Low | Value | Volume |
| 10.5¢ | 10.5¢ | 9.8¢ | $58.09K | 574.8K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 38503 | 10.0¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| 10.5¢ | 194063 | 5 |
View Market Depth
| Last trade - 16.10pm 04/10/2024 (20 minute delay) ? |
| PER (ASX) Chart |