Australia's largest stock trading and investment forum Australia's #1 stock forum

MSB

Click for more information

1.01%

98.0¢ mesoblast limited

Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-254

First 254 Last

Share
Profile

Follow
Phaedrus

1,436 Posts.

3143

13/03/24

06:00

Post #: 72857756
Share

Originally posted by Blackkkkkkk: ↑

Hi All

Thanks for all your replies, and yes, my question was in relation to the approval pathway for gvhd for kids, in a hypothetical scenario where the FDA accepts in the upcoming meeting the additional potency assay that's been provided by MSB as satisfactory response to its complete response letter. Sorry for posting this question in the wrong thread (must have been the reason for the confusion), but I just wanted some clarity on, in this hypothetical scenario:

1. Does MSB have to submit a new BLA including the additional assay and be subjected to the normal review period, or does MSB have the benefit of a rolling review for gvhd for kids as well?
2. In either case, what would be the anticipated review period by the FDA to grant full approval on gvhd for kids?
3. Assuming FDA is not going to approve gvhd for kids "on the spot" (i.e. at the meeting) as it will be subject to a review process, what is the "best" ASX announcement that we can expect to hear from MSB after the meeting?

Expand

I think you'll find answers to many of your questions here: https://www.fda.gov/media/84417/download

Regarding content of any post-meeting announcements, we'll have the real thing in short order, IMO.

GLTAH

MSB Price at posting: 39.5¢ Sentiment: Buy Disclosure: Held
9 Upvote

0 Great analysis

Reply

Top Stories

End of FY is a time to juggle wins, losses and capital gains taxes

Eurozone-based companies find new ways to secure a regional lithium supply

Time for retail therapy buying in the shopping Scentre for hot stocks

With financials holding the fort, materials must step up with some heavy lifting to stimulate stocks

SS1

Sun Silver submits US$60M Silver Paste Funding Application to US DoE

There are more pages in this discussion • 296 more messages in this thread...

First 254 Last

Add MSB (ASX) to my watchlist

(20min delay)
Last 98.0¢		Change -0.010(1.01%)		Mkt cap ! $1.118B

Open	High	Low	Value	Volume
$1.00	$1.01	98.0¢	$4.720M	4.751M

Buyers (Bids)

No.	Vol.	Price($)
10	171759	98.0¢

Sellers (Offers)

Price($)	Vol.	No.
99.0¢	16000	1

View Market Depth

No.	Vol.	Price($)
10	171759	0.980
6	123454	0.975
9	228392	0.970
6	122208	0.965
10	79500	0.960

Price($)	Vol.	No.
0.990	16000	1
0.995	62678	2
1.000	70444	6
1.005	27224	1
1.010	48336	6

Last trade - 16.10pm 25/06/2024 (20 minute delay)

MSB (ASX) Chart