it’s a process , the FDA has told mesoblast they agree the CQA’s they can use to link the quality and purity of the product to clinical effectiveness.
now Mesoblast need to use those CQA’s and apply it to the in vivo data ( the phase 3 trial data ) which will then allow the FDA to accept that successful phase 3 trial and not need a new trial to demonstrate potency.
Also keep in mind, IMO this progress confirmed today means Mesoblast have all they need to progress with CoViD trial, while they sort this BLA out.
Ann: Update on FDA Meeting for Remestemcel-L in Paediatric GvHD, page-51
-
- There are more pages in this discussion • 161 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
$1.01 |
Change
0.000(0.00%) |
Mkt cap ! $1.147B | |||
| Open | High | Low | Value | Volume |
| $1.02 | $1.02 | $1.00 | $814.7K | 808.8K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 11 | 26006 | $1.01 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.01 | 31798 | 9 |
View Market Depth
| Last trade - 11.39am 19/08/2024 (20 minute delay) ? |
| MSB (ASX) Chart |