Shouldn't need to do new clinical trials (validation) as long as they can show equivalence of the product (verification). That's why those Critical Quality Attributes (CQA) are important to be accepted by FDA in the Ryoncil approval. Those CQA's and many other quality parameters that are measured during raw materials acceptance, in process testing and final product testing will need to show equivalence between both processes.
Regenerative Medicine and Cell Therapies Virtual Event, page-43
-
- There are more pages in this discussion • 87 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
 (20min delay)
|
|||||
|
Last
$1.19 |
Change
0.085(7.69%) |
Mkt cap ! $1.358B | |||
| Open | High | Low | Value | Volume |
| $1.10 | $1.20 | $1.09 | $13.21M | 11.37M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 15000 | $1.19 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.19 | 75212 | 5 |
View Market Depth
| Last trade - 16.10pm 12/07/2024 (20 minute delay) ? |
| MSB (ASX) Chart |