Well the FDA is continuing to talk about what is needed to get good clinical data in late stage INDs so products can progress to application for approval, as part of its upcoming OTP Townhall Series, this time on CMC readiness for cellular products on 5 Sep - by now the industry should know how seriously the agency takes CMC
ihttps://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/otp-town-hall-cell-therapy-cmc-readiness-late-stage-inds-09052024
ssues for these products, and how much added significance they have compared to small molecule drugs - see above.
So you can’t say there’s lack of a will now, so there must be a way.
Well the FDA is continuing to talk about what is needed to get...
-
- There are more pages in this discussion • 223 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
$1.13 |
Change
0.035(3.21%) |
Mkt cap ! $1.284B | |||
| Open | High | Low | Value | Volume |
| $1.09 | $1.13 | $1.07 | $3.910M | 3.535M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 2 | 27197 | $1.11 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.13 | 43578 | 3 |
View Market Depth
| Last trade - 16.10pm 27/09/2024 (20 minute delay) ? |
| MSB (ASX) Chart |