FDA's Expedited Approval Mechanisms for New Drug Products - PMC
Starpharma’s DEP carbaxitaxel and DEP irinotecan definitely meet FDA criteria for accelerated approval. Time frame: 6 months from application. Have SPL filed? Hopefully carbaxitaxel is in already. Hopefully they can file irinotecan quickly.
“The primary benefit of receiving Priority Review is a reduction of four-months in the projected review time by FDA. FDA aims to complete review of an NDA for a compound with a Priority Review designation within six months; the goal for a compound with a Standard Review designation is to complete review within ten months. In addition, FDA intends “to direct overall attention and resources to the evaluation of applications for” Priority Review drug products.”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326266/
- Forums
- ASX - By Stock
- SPL
- Priority and Breakthrough Drugs -FDA
Priority and Breakthrough Drugs -FDA
-
-
- 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)
Featured News
Add SPL (ASX) to my watchlist
|
|||||
Last
9.6¢ |
Change
0.000(0.00%) |
Mkt cap ! $39.58M |
Open | High | Low | Value | Volume |
9.7¢ | 9.8¢ | 9.4¢ | $31.6K | 324.0K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 97704 | 9.6¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
9.7¢ | 75000 | 1 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 97704 | 0.096 |
1 | 59000 | 0.095 |
1 | 11059 | 0.094 |
1 | 100000 | 0.093 |
1 | 49413 | 0.091 |
Price($) | Vol. | No. |
---|---|---|
0.097 | 75000 | 1 |
0.098 | 136 | 1 |
0.099 | 94163 | 2 |
0.100 | 162106 | 5 |
0.105 | 116531 | 4 |
Last trade - 16.10pm 29/08/2024 (20 minute delay) ? |
Featured News
SPL (ASX) Chart |