Remember Lassman wants the FDA to reject our BLA? They wanted us to do a proper randomized control trial? KARMA is a bieetch, I believe it is likely that the FDA will approve Ryoncil for children SR aGVHD, but I could see a phase 4 RCT trial to treat the adult population as one of the requirement for approval. The Lassman wanted a RCT, i think they will get it!!! And as I mentioned earlier Jakafi's efficacy is rubbish especially for those patients with grade III and IV disease. I think SI is more than happy to conduct the extension trial together with the FDA.
Ryoncil: ODAC/FDA Meeting Discussion, page-1991
Add MSB (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$1.15 |
Change
0.045(4.07%) |
Mkt cap ! $1.313B | |||
| Open | High | Low | Value | Volume |
| $1.08 | $1.16 | $1.08 | $4.681M | 4.170M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 99680 | $1.15 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.16 | 31000 | 2 |
View Market Depth
| Last trade - 16.10pm 19/07/2024 (20 minute delay) ? |
| MSB (ASX) Chart |