On the 17th November we were advised that the FDA would not agree to accelerated approval for Rem-l for kids.
On Dec 7th we were informed of in vivo bio markers evidence linking Rem-l efficacy in SR-aGHVD survival.
Today we have been informed that
Mesoblast held a Type A meeting with the FDA in November 2020 to discuss the review of the
Biologics License Application for remestemcel-L. The current review team have not agreed to
accelerated approval. However, there was consensus with the review team on the proposed
optimization of potency assays and on use of biomarkers to demonstrate the product’s bioactivity invivo
THAT IS NEW INFORMATION.
Let me translate that- this current review team is a bunch of knobs (boks) who have had to concede some scientific facts.
The appeal process review team won't be the same boks.
Let the kids be treated while we run a confirmatory trial in Adults.
Tic toc
Reg
MSB Trading 2021 - paradigm shift, page-1211
-
- There are more pages in this discussion • 9,000 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
0.020(1.72%) |
Mkt cap ! $1.358B | |||
| Open | High | Low | Value | Volume |
| $1.15 | $1.20 | $1.15 | $1.167M | 997.6K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 16 | 92864 | $1.18 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.19 | 895 | 1 |
View Market Depth
| Last trade - 10.53am 16/07/2024 (20 minute delay) ? |
| MSB (ASX) Chart |