MSB 2.10% $1.17 mesoblast limited

MSB to dispute FDA finding in Type A meeting, page-368

  1. 8,320 Posts.
    lightbulb Created with Sketch. 805
    Just one thing: MSB have been working closely with FDA for years on trying to get approval on ryoncil: the primary endpoints agreed on, and met, yet only to be met by a "sorry we need an RCT in some form". Seems like FDA could have expressed this concern or advised MSB before commencing the phase 3 trial? this would be on FDA for not advising or guiding MSB properly on conducting a trial that would satisfy them? im not in the camp of the anti-Lizard People, but seems like negligence(?) or FDA finding an excuse to defer due dilligence on approval to manage their current workload: accusations aside and tldr: why was this need for a RCT a suprise?
 
watchlist Created with Sketch. Add MSB (ASX) to my watchlist
(20min delay)
Last
$1.17
Change
-0.025(2.10%)
Mkt cap ! $1.324B
Open High Low Value Volume
$1.18 $1.22 $1.15 $4.263M 3.613M

Buyers (Bids)

No. Vol. Price($)
32 29260 $1.16
 

Sellers (Offers)

Price($) Vol. No.
$1.17 11683 6
View Market Depth
Last trade - 13.49pm 15/07/2024 (20 minute delay) ?
MSB (ASX) Chart
arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.