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

MSB

Click for more information

0.43%

$1.16 mesoblast limited

https://www.fda.gov/media/120267/downloadLink above is to the...

First 13 Last

Share
Profile

Follow
irenekwshiu

325 Posts.

359

04/03/24

16:50

Post #: 72736575
Share

Originally posted by irenekwshiu: ↑

I raised with the company by email in early Feb the below guidance. It is extremely interesting, in that it highlights on p.10 the circumstances, under the relevant section of the FD&C Act, as added by the Cures Act, whereby RMATs may be eligible for accelerated approval, based on either (1) pre-agreed surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit; OR (2) reliance on data from a meaningful number of sites. The DREAM trial involved over 50 sites, so this is definitely something that could have been raised with the FDA in the very recent adult HF meeting with the FDA on Revascor, which has the RMAT (Regenerative Medicine Advanced Therapy) designation.

https://www.fda.gov/media/120267/download#:~:text=2%20Under%20section%20506(.g,therapy%E2%80%9D%20(RMAT)%20designation.

Expand

https://www.fda.gov/media/120267/download

Link above is to the actual guidance doc - sorry the one I previously posted seems to have been truncated - please read p.10.

MSB Price at posting: 29.5¢ Sentiment: Hold Disclosure: Held
12 Upvote

0 Great analysis

Reply

Top Stories

I88

Large fault structure and uranium anomalies picked up by Infini at Newfoundland play

HBF to throw 10% vote behind NDC BidCo's buyout of Pacific Smiles Group

PH2

Pure Hydrogen inks MOU for 5 hydrogen buses in Saigon – days after Twiggy's FFI reeled back in

29M

High-grade copper results provide some relief to 29Metals after earlier mine shutdown

Biden's exit bakes in a Kamala Harris ballot while markets expect Trump to win. How could equities fare this week?

There are more pages in this discussion • 865 more messages in this thread...

First 13 Last

Add MSB (ASX) to my watchlist

(20min delay)
Last $1.16		Change 0.005(0.43%)		Mkt cap ! $1.318B

Open	High	Low	Value	Volume
$1.15	$1.17	$1.13	$3.743M	3.261M

Buyers (Bids)

No.	Vol.	Price($)
4	78561	$1.15

Sellers (Offers)

Price($)	Vol.	No.
$1.16	114667	4

View Market Depth

No.	Vol.	Price($)
4	78561	1.145
4	151270	1.140
4	53395	1.135
6	133073	1.130
3	101104	1.125

Price($)	Vol.	No.
1.160	114667	4
1.165	45573	3
1.170	67634	7
1.175	40867	3
1.180	27096	4

Last trade - 16.10pm 22/07/2024 (20 minute delay)

MSB (ASX) Chart