MSB 2.08% 94.0¢ mesoblast limited

Overwhelming efficacy - the stats required, page-279

  1. 1,216 Posts.
    lightbulb Created with Sketch. 1375
    That's a good point. I've managed to pull up some information that may help answer your question.

    https://osp.od.nih.gov/wp-content/uploads/2013/08/ucm127073%20change%20expir%20date%20Clinical%20trial%20data%20monitoring_0.pdf

    7.2.1. DMC Recommendations to Terminate the Study In almost all cases, a DMC is advisory to the sponsor; the sponsor decides whether to accept recommendations to discontinue a trial. FDA will rarely, if ever, tell a sponsor which decision to make. For trials that may be terminated early because a substantial benefit has been observed, however, consideration may still need to be given to the adequacy of data with regard to other issues such as safety, duration of benefit, outcomes in important subgroups and important secondary endpoints. We recommend that sponsors of trials that could potentially be terminated early for efficacy reasons discuss these issues with FDA prior to implementing the trial, when the statistical monitoring plan and early stopping boundaries are being developed. In these settings, consultation with FDA may provide the sponsor with important information regarding the regulatory and scientific implications of a decision and may lead to better decisions. Sponsors are encouraged to revisit these issues with FDA when considering DMC recommendations for early termination if new issues have arisen and/or if the regulatory implications of early termination were not adequately clarified at the outset of the trial.




 
watchlist Created with Sketch. Add MSB (ASX) to my watchlist
(20min delay)
Last
94.0¢
Change
-0.020(2.08%)
Mkt cap ! $1.073B
Open High Low Value Volume
95.5¢ 97.0¢ 93.5¢ $1.424M 1.507M

Buyers (Bids)

No. Vol. Price($)
8 29390 93.5¢
 

Sellers (Offers)

Price($) Vol. No.
94.5¢ 14089 2
View Market Depth
Last trade - 16.10pm 13/09/2024 (20 minute delay) ?
MSB (ASX) Chart
arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.