I raised with the company by email in early Feb the below guidance. It is extremely interesting, in that it highlights on p.10 the circumstances, under the relevant section of the FD&C Act, as added by the Cures Act, whereby RMATs may be eligible for accelerated approval, based on either (1) pre-agreed surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit; OR (2) reliance on data from a meaningful number of sites. The DREAM trial involved over 50 sites, so this is definitely something that could have been raised with the FDA in the very recent adult HF meeting with the FDA on Revascor, which has the RMAT (Regenerative Medicine Advanced Therapy) designation.
https://www.fda.gov/media/120267/download#:~:text=2%20Under%20section%20506(.g,therapy%E2%80%9D%20(RMAT)%20designation.
- Forums
- ASX - By Stock
- 2024 Here we go again.
I raised with the company by email in early Feb the below...
-
-
- There are more pages in this discussion • 932 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 MSB (ASX) to my watchlist
|
|||||
Last
97.0¢ |
Change
-0.005(0.51%) |
Mkt cap ! $1.107B |
Open | High | Low | Value | Volume |
98.5¢ | 98.5¢ | 96.0¢ | $2.168M | 2.226M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 16000 | 96.5¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
97.0¢ | 86854 | 7 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 16000 | 0.965 |
1 | 23000 | 0.960 |
4 | 56273 | 0.955 |
5 | 46225 | 0.950 |
2 | 65500 | 0.945 |
Price($) | Vol. | No. |
---|---|---|
0.970 | 50000 | 2 |
0.975 | 20000 | 1 |
0.980 | 894 | 1 |
0.985 | 48122 | 2 |
0.990 | 54328 | 5 |
Last trade - 16.10pm 23/08/2024 (20 minute delay) ? |
MSB (ASX) Chart |
The Watchlist
SER
STRATEGIC ENERGY RESOURCES LIMITED
David DeTata, Managing Director
David DeTata
Managing Director
SPONSORED BY The Market Online