The MRI + BML data could definitely act as a surrogate endpoint and be used for accelerated approval. So too could the biomarker data, as long as they correlate with the pain and function endpoints. In theory, PAR could apply for accelerated approval in 2023 or early 2024 when they get the results from the P2b PARA 002 study. By this point they would have three sets of results from randomized double-blinded trials that they could submit to the FDA: 005, 008 and 002 part I.
Fast Track, page-14
-
- There are more pages in this discussion • 4 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 PAR (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
22.0¢ |
Change
0.000(0.00%) |
Mkt cap ! $76.95M | |||
| Open | High | Low | Value | Volume |
| 22.0¢ | 23.5¢ | 22.0¢ | $66.95K | 294.6K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 8 | 90092 | 22.0¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| 23.5¢ | 25858 | 1 |
View Market Depth
| Last trade - 16.10pm 14/08/2024 (20 minute delay) ? |
| PAR (ASX) Chart |