Interpretation of the Policy is significant for Mesoblast and its requirements to the FDA
https://www.fda.gov/downloads/Biolo...uidances/CellularandGeneTherapy/UCM585403.pdf
Do MSB's products fall under the category of Homologous use?
Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.
The interpretation of the regs and definition of MSB'd products ie; structural or non structural cells, homologous or non-homologous could make a big diff to how its products are regulated via this flow chart.
![]()
- Forums
- ASX - By Stock
- MSB
- FDA announce new policy approach
FDA announce new policy approach, page-30
-
- There are more pages in this discussion • 48 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
|
|||||
Last
$1.01 |
Change
0.015(1.52%) |
Mkt cap ! $1.158B |
Open | High | Low | Value | Volume |
99.5¢ | $1.02 | 98.5¢ | $1.400M | 1.393M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
25 | 149057 | $1.00 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.01 | 86838 | 19 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
25 | 160184 | 1.000 |
12 | 177604 | 0.995 |
16 | 260863 | 0.990 |
8 | 539324 | 0.985 |
8 | 54570 | 0.980 |
Price($) | Vol. | No. |
---|---|---|
1.005 | 3661 | 4 |
1.010 | 97768 | 17 |
1.015 | 88636 | 10 |
1.020 | 127945 | 17 |
1.025 | 144002 | 6 |
Last trade - 12.09pm 15/08/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |
The Watchlist
I88
INFINI RESOURCES LIMITED
Charles Armstrong, CEO & Managing Director
Charles Armstrong
CEO & Managing Director
SPONSORED BY The Market Online