They way I see it is:
Significant reduction in recurrent hospitalisations + reduction in mortality = best result, could go for accelerated approval + big partner guaranteed
Significant reduction in mortality only = next best outcome, still have a chance for accelerated approval + big partners would be interested, but not guaranteed.
Significant reduction in recurrent hospitalisations only = bad outcome, no chance of accelerated approval + no big partners would be interested.
No improvement in any of the primary or key secondary endpoint = disastrous outcome.
The meeting with the FDA will be very interesting... 60% reduction in mortality in Class II patients is going to catch the attention of big pharmas, but how strong the case is for partnership will depend on what the FDA says as well as how all the other secondary endpoints stacked up ... because the p values generated for mortality in such a small patient population (relative to others using mortality as an endpoint) may be able to stand on it's own two feet for approval (p=0.037). MACE events may be the preferred primary end-point in the confirmatory trial, with mortality the key secondary endpoint (to reduce patient population required).
My guess is that CLBP read-out will come out later this week, and the longer the COVID ARDS 60% read-out remains unannounced ... the more likely we'll get a positive read-out IMO.
- Forums
- ASX - By Stock
- Ann: Mesoblast Phase 3 Chronic Heart Failure Results
They way I see it is:Significant reduction in recurrent...
-
- There are more pages in this discussion • 703 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
|
|||||
Last
$1.05 |
Change
0.080(8.25%) |
Mkt cap ! $1.198B |
Open | High | Low | Value | Volume |
99.5¢ | $1.06 | 99.0¢ | $4.930M | 4.779M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 23545 | $1.05 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.05 | 339479 | 5 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 23545 | 1.045 |
1 | 10000 | 1.040 |
8 | 181213 | 1.035 |
15 | 391706 | 1.030 |
1 | 15570 | 1.025 |
Price($) | Vol. | No. |
---|---|---|
1.050 | 339479 | 5 |
1.055 | 21365 | 3 |
1.060 | 376981 | 13 |
1.065 | 55888 | 5 |
1.070 | 93334 | 6 |
Last trade - 16.10pm 04/07/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |