Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-997

  1. 7,022 Posts.
    lightbulb Created with Sketch. 2331
    September 2023, MSB announcement

    https://hotcopper.com.au/data/attachments/6248/6248812-08580e058a132c539137c969d1d5d58f.jpg

    March 2024. MSB meets with FDA regarding potency data.

    March 2024. MSB says they have feedback from FDA, and

    "U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD)."

    So the assay prevented the study from being adequate. MSB provided more assay data and had a meeting with FDA about assays. Now the FDA says the study appears sufficient to support resubmission.

    Could it be that FDA's review of the new assay data has led them to look more favorably upon the study?

    Just connecting dots.


 
Add to My Watchlist
What is My Watchlist?
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)
Last
$1.61
Change
0.030(1.90%)
Mkt cap ! $2.057B
Open High Low Value Volume
$1.58 $1.64 $1.58 $3.004M 1.865M

Buyers (Bids)

No. Vol. Price($)
44 77261 $1.60
 

Sellers (Offers)

Price($) Vol. No.
$1.61 34357 25
View Market Depth
Last trade - 12.49pm 10/07/2025 (20 minute delay) ?
MSB (ASX) Chart
arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.