As described in Section 3033 of the 21stCentury Cures Act, a drug is eligible for regenerative medicine advanced therapy (RMAT) designation if:
- The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;
- The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
- Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition
So many irons in the fire
Reg
- Forums
- ASX - By Stock
- MSB
- Ann: FDA Grants RMAT Designation for Rexlemestrocel-L in CLBP
Ann: FDA Grants RMAT Designation for Rexlemestrocel-L in CLBP, page-3
-
- There are more pages in this discussion • 142 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 MSB (ASX) to my watchlist
(20min delay)
|
|||||
Last
$1.51 |
Change
0.020(1.34%) |
Mkt cap ! $1.724B |
Open | High | Low | Value | Volume |
$1.57 | $1.58 | $1.41 | $18.15M | 12.09M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 3418 | $1.50 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.51 | 24361 | 5 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 3418 | 1.500 |
1 | 13000 | 1.495 |
7 | 91808 | 1.490 |
4 | 58451 | 1.485 |
7 | 138437 | 1.480 |
Price($) | Vol. | No. |
---|---|---|
1.510 | 24361 | 5 |
1.515 | 44181 | 1 |
1.520 | 192161 | 6 |
1.525 | 36465 | 2 |
1.530 | 29631 | 3 |
Last trade - 16.10pm 07/10/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |