Booooom!
All clinical aspects are 100% ok......I'm expecting one big trial including EMEA and FDA - with "pivotal data" to be used in both markets.
"The meeting was constructive and provided clarification on a path towards initiating a Phase IIb/III study in the US."
Non-clinical requirements are to be further reviewed and agreed with the FDA to assess if and how they may impact on the timing of clinical study initiation. The feedback will be reviewed by our internal team and incorporated into our global clinical development and commercialisation plans.
Mark Diamond CEO of Antisense Therapeutics said: “Based on the guidance meeting with the FDA, together with prior feedback from EMA and world leading DMD experts, we are reassured that the data from our Phase II study is encouraging and that it is reasonable and appropriate to advance the program towards potentially pivotal clinical studies. It is our goal to bring this medication to as many DMD patients worldwide as possible”.
- Forums
- ASX - By Stock
- PER
- Ann: US FDA Type C Meeting for ATL1102 in DMD
Ann: US FDA Type C Meeting for ATL1102 in DMD, page-4
- There are more pages in this discussion • 84 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 PER (ASX) to my watchlist
(20min delay)
|
|||||
Last
7.5¢ |
Change
-0.001(1.32%) |
Mkt cap ! $67.61M |
Open | High | Low | Value | Volume |
7.6¢ | 7.7¢ | 7.5¢ | $38.88K | 514.5K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 39300 | 7.6¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
7.9¢ | 26315 | 1 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 39300 | 0.076 |
1 | 52933 | 0.075 |
1 | 120000 | 0.074 |
3 | 81162 | 0.073 |
3 | 322000 | 0.072 |
Price($) | Vol. | No. |
---|---|---|
0.079 | 26315 | 1 |
0.080 | 102781 | 2 |
0.081 | 500001 | 1 |
0.083 | 100000 | 1 |
0.084 | 177402 | 1 |
Last trade - 15.19pm 21/05/2024 (20 minute delay) ? |
|
|||||
Last
7.8¢ |
  |
Change
-0.001 ( 1.27 %) |
|||
Open | High | Low | Volume | ||
7.6¢ | 7.8¢ | 7.5¢ | 112689 | ||
Last updated 15.50pm 21/05/2024 ? |
Featured News
PER (ASX) Chart |
The Watchlist
ATC
ALTECH BATTERIES LTD
Martin Stein, CFO
Martin Stein
CFO
Previous Video
Next Video
SPONSORED BY The Market Online