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

MSB

Click for more information

2.51%

97.0¢ mesoblast limited

Ann: FDAs OTAT Agrees to Primary Endpoint for Back Pain, page-106

First 106 Last

Share
Profile

Follow
Stellowe

635 Posts.

315

16/12/21

11:33

Post #: 58333487
Share

Originally posted by stockrock: ↑

One thing that is easily measurable is opioid use, and for 40% of patients to voluntarily (against the advice of those running the trial) stop the use of opioids mid trial, taking into account the addictiveness of the substance... is in my mind quite telling.

the pain reduction seen in MSB's phase 3 trial was substantial, so we are not talking minor improvements in pain score here.

I'm glad to see the single primary endpoint.. I was almost certain the FDA would make it a composite with pain and opioid sparring.. which would be complimentary anyway, but this is an even better outcome.

It's also interesting to see the evolution of what would have been several rounds of guidance from the FDA to ultimately arrive at this final guidance.

If we translate that the CHF program, what guidance has the FDA given Mesoblast to alter their target population for an accelerated approval pathway? If the CLBP discussions are anything to go by... has the FDA steered Mesoblast to push for accelerated approval? It's a pretty bold move by Mesoblast, backed by strong data.. but bold nonetheless... and IMO most likely guided by the FDA.

Expand

consider the shorter duration group.

MSB Price at posting: $1.49 Sentiment: None Disclosure: Held
14 Upvote

0 Great analysis

Reply

Top Stories

ADH

Adairs MD and CEO steps down after 17 years in company management

Is the ASX getting its groove back? Here's 5 IPOs in September to watch

FEG

China's Xingye snags 19.99% stake in Far East Gold, eyeing latter's Indonesian gold play

DEL

Delorean unlocks $30M through Tanarra finance facility for bioenergy projects

SRN

Copper and zinc zone prove exciting news for Surefire close to WA's Yidby

There are more pages in this discussion • 303 more messages in this thread...

First 106 Last

Add MSB (ASX) to my watchlist

(20min delay)
Last 97.0¢		Change -0.025(2.51%)		Mkt cap ! $1.107B

Open	High	Low	Value	Volume
99.0¢	$1.03	97.0¢	$2.815M	2.838M

Buyers (Bids)

No.	Vol.	Price($)
9	151781	97.0¢

Sellers (Offers)

Price($)	Vol.	No.
97.5¢	80522	1

View Market Depth

No.	Vol.	Price($)
9	151781	0.970
5	72712	0.965
9	134156	0.960
4	43363	0.955
11	224934	0.950

Price($)	Vol.	No.
0.975	80522	1
0.990	33914	1
0.995	72449	5
1.000	61847	4
1.005	96389	3

Last trade - 16.10pm 05/09/2024 (20 minute delay)

MSB (ASX) Chart