Timeline Update
FDA recieved BLA resubmision for GvHD on 2Feb23
FDA announced PDUFA date of 2Aug23
GVHD approval decision 2 Apr 23 to 2 Aug 23 ( 2 - 6 months for fast track*)
*Zanubrutinib - a drug for treating mantle cell lymphoma, was approved over 3 months ahead of its PDUFA date, late in 2019, along with at least onother 4 drugs, all approved earlier than the PDUFA date given by the FDA.
Crizanlizumab-tmca approved 2 months before PDUFA in 2020.
Voxelotor accelerated approval three months before PDUFA.
Givosiran 2.5 months before it's PDUFA date.
It is not a given that the yes / no will occur on the actual PDUFA date.
Source : https://endpts.com/fda-approves-5-new-costly-drugs-well-ahead-of-pdufa-dates/
CLBP trial commence by mid 23
Source : https://hotcopper.com.au/threads/ann-msb-q2-financial-results-and-operational-highlights.7254868/
CHF FDA most direct path forward ( AA ? ) Q2 - 23
Company is considering smaller groups - the most severe patients or limiting the treatment group to those that benefit the most.
Source : https://hotcopper.com.au/threads/ann-msb-q2-financial-results-and-operational-highlights.7254868/
- Forums
- ASX - By Stock
- MSB
- 2023 The Final Countdown
2023 The Final Countdown, page-53
-
- There are more pages in this discussion • 3,351 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add MSB (ASX) to my watchlist
(20min delay)
|
|||||
Last
$1.07 |
Change
-0.025(2.29%) |
Mkt cap ! $1.216B |
Open | High | Low | Value | Volume |
$1.10 | $1.10 | $1.06 | $4.942M | 4.613M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
6 | 70659 | $1.07 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.07 | 43531 | 2 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
6 | 70659 | 1.065 |
10 | 321922 | 1.060 |
10 | 163165 | 1.055 |
18 | 145872 | 1.050 |
5 | 82472 | 1.045 |
Price($) | Vol. | No. |
---|---|---|
1.070 | 43531 | 2 |
1.075 | 45000 | 1 |
1.080 | 12400 | 2 |
1.085 | 37622 | 4 |
1.090 | 28097 | 2 |
Last trade - 16.10pm 20/06/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |
The Watchlist
MTL
MANTLE MINERALS LIMITED
Nick Poll, Executive Chairman
Nick Poll
Executive Chairman
Previous Video
Next Video
SPONSORED BY The Market Online