So, my understanding is that it's not a RCT because there will be no placebo involved. The new trial is for the sickest of adult patients who have already failed all other forms of therapy...
So, the RCT you've been going on about is not actually the requirement here.
Last time the FDA asked for more data (recommended an RCT) and they got more data. This time they're asking for more data but not asking for a RCT.
Ann: Update on BLA for Graft Versus Host Disease, page-146
Add MSB (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$1.11 |
Change
0.000(0.00%) |
Mkt cap ! $1.267B | |||
| Open | High | Low | Value | Volume |
| $1.13 | $1.13 | $1.06 | $12.24M | 11.22M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 32118 | $1.11 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.12 | 21178 | 2 |
View Market Depth
| Last trade - 16.10pm 31/05/2024 (20 minute delay) ? |
|
|||||
|
Last
$1.10 |
Change
0.000 ( 2.07 %) |
||||
| Open | High | Low | Volume | ||
| $1.12 | $1.12 | $1.06 | 1826006 | ||
| Last updated 15.59pm 31/05/2024 ? | |||||
| MSB (ASX) Chart |