===FDA Approval Timeline===
****Achieved to date...****
1. CVac™ commenced research in 1996.
2. Phase I trials commenced in 2001. Trails conducted on 14 patients with a variety of malignant tumours
3. Phase II trials completed in 2007. Trials conducted on 21 patients with elevated CA125 levels (a key biomarker for disease activity)
4. FDA pre-Investigational New Drug Application (preIND) meeting request complete August 2008. A PreIND meeting is a key milestone in FDA approval process
5. FDA pre-Investigational New Drug Application (preIND) meeting, successfully completed - October 2008
***Upcoming...***
1. Commence US FDA IND application for CVac™ - May 2009
2. US FDA grant of Investigational New Drug Application (IND) for CVac™ ovarian cancer treatment - mid-2009. Confirms data, manufacturing and statistics all to FDA standards
3. Pivotal Clinical Trial to commence – mid-2009. Trial to be conducted on total of 340 patients(approx) in 3 tranches
4. FDA grant of Biological Licence Authority (BLA). BLA allows company to commence charging for use of Cvac™
5. Full commercialisation of Cvac™. Licensing or sale to pharmaceutical/drug major
- Forums
- ASX - By Stock
- IMM
- bet for dollars->a dream?
bet for dollars->a dream?, page-5
-
-
- There are more pages in this discussion • 21 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 IMM (ASX) to my watchlist
(20min delay)
|
|||||
Last
29.0¢ |
Change
0.020(7.41%) |
Mkt cap ! $421.8M |
Open | High | Low | Value | Volume |
27.5¢ | 29.5¢ | 27.0¢ | $1.138M | 3.985M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
2 | 63444 | 28.5¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
29.5¢ | 65000 | 2 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
2 | 63444 | 0.285 |
4 | 117015 | 0.280 |
6 | 230290 | 0.275 |
11 | 813246 | 0.270 |
5 | 128795 | 0.265 |
Price($) | Vol. | No. |
---|---|---|
0.295 | 65000 | 2 |
0.300 | 243878 | 7 |
0.305 | 187248 | 3 |
0.310 | 148973 | 5 |
0.315 | 120000 | 2 |
Last trade - 16.10pm 08/11/2024 (20 minute delay) ? |
Featured News
IMM (ASX) Chart |
The Watchlist
EQN
EQUINOX RESOURCES LIMITED.
Zac Komur, MD & CEO
Zac Komur
MD & CEO
SPONSORED BY The Market Online