as on ymb :
Shares of Amicus Therapeutics Inc. jumped after a European regulatory panel recommended its drug for a rare genetic disorder
Here's an example of moving forward in EU after being asked by the FDA for more information.
13 months and counting to react to partial clinical hold.
This is a prime example of the EMA showing more flexibility than FDA with orphan disease drugs. In October 2015 FDA asked FOLD for more information after their Phase 3. And yesterday EMA approved FOLD's marketing authorization for the same drug. As we have said many time here, the EMA exhibits more flexibility especially for orphan diseases. This will likely be similar to what Prana will see with the EMA for PBT2.
- Forums
- ASX - By Stock
- ATH
- EMA flexibility
EMA flexibility
-
- There are more pages in this discussion • 11 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add ATH (ASX) to my watchlist
|
|||||
Last
0.3¢ |
Change
0.000(0.00%) |
Mkt cap ! $15.96M |
Open | High | Low | Value | Volume |
0.3¢ | 0.3¢ | 0.3¢ | $38.48K | 12.82M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
53 | 77190096 | 0.2¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
0.3¢ | 6269051 | 4 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
53 | 77190096 | 0.002 |
24 | 118010099 | 0.001 |
0 | 0 | 0.000 |
0 | 0 | 0.000 |
0 | 0 | 0.000 |
Price($) | Vol. | No. |
---|---|---|
0.003 | 6269051 | 4 |
0.004 | 131845243 | 24 |
0.005 | 21242406 | 24 |
0.006 | 22158304 | 18 |
0.007 | 47726651 | 22 |
Last trade - 16.10pm 06/09/2024 (20 minute delay) ? |
Featured News
ATH (ASX) Chart |