MSB

2.17%

$1.13 mesoblast limited

Very True, The FDA are certainly in no hurry to approve.On...

First 328 Last

Share
Profile

Follow
Broderick

349 Posts.

7

17/11/20

12:03

Post #: 48927293
Share

Originally posted by dontfollowme: ↑

SIR-spheres = Was classed as a "device" so took an easier path thru the FDA minefield, compared to "drug" pathways. Got approved for CEmark TGA and FDA without too many hiccups.
Cell based therapy a new realm which the FDA have showed they seem somewhat adverse too.......understanding?? ODAC was convinced by Ryoncil cept for Hinrich who appears to have the FDA's ear/pocket.
FDA were correct in questioning single arm trial, but endorsed it previously enough to give BLA submission, Did not indicate that 69% survival success from Phase 3 in children would not be enough to sway he stats for efficacy till the final hurdle....then pulled the rug out.
FDA seem to be treating it like the Rosetta stone......no compredo. FDA adverse to gene/cell based treatment approval.
Other market approval strategy may work instead...don't know why this has not been addressed by the company already for CEmark/TGA for Ryoncil, new capital funds should already be earmarked for this......why not? I would ask this question at AGM.
Occurence of Leukemia is worldwide lets focus elsewhere and leave the FDA holding the empty cot so to speak.
Why not target 1st worl economies with more forward thinking heathcare? Why not China/Asia/Canada/European Union....even Russia. Get some alternatives happening for market in roads...don't pin hopes all in on a dinosaur riddled archaic approval system which has already higlighted that even with expert advice on proven treatment without side effects in a feild where there is little alternative cept death. They hum and haa and go now bout we start from scratch again.........fark that.
If Type A rejected, no accelerated pathway is agreed to I feel its time to pull up the stumps for USA and present a new direction.
Either the Pharma industry there see's disruptive treatment a real threat to their script based gravy train of ongoing cashcows or the FDA is to Prolife conservative mindset to introduce any new gene/cell treatments. ok vented.
Market down...screen blank KZA was off to the races then............halted. Pah!!
Also forgot to mention MSB recieved huge accolades from the peer voted Biotech awards - Fierce, no avail.

Expand

Very True, The FDA are certainly in no hurry to approve.
On another issue Mesoblast stated very clearly at the start of this year that trial results for back pain and the heart would be released mid year.
Well we a four months out and nothing, there was conjecture that the results would be announced at the American heart association meeting?
Well nothing!

MSB Price at posting: $3.28 Sentiment: Hold Disclosure: Held
5 Upvote

0 Great analysis

Reply

Top Stories

ASX Market Open: ASX200 to rise for Friday session | July 26

TRP

Tissue Repairs soars nearly 32% on TGA approval for wound healing gel

RHK

Red Hawk upgrades Blacksmith with DSO mineral resource at the Eagle Deposit

MND

Monadelphous inks $200M contract with Woodside to help build Pluto LNG – but will it make Scarborough cheaper?

MIN

MinRes jumps 5% as the company meets production guidance – depressed iron ore prices be damned

Nine's staff strike as Paris Olympic coverage begins

IGO

IGO kicks off earn-in copper drilling on-site Encounter's Yeneena play as it adopts new identity

HRZ

Horizon firms up ore reserve for Boorara ahead of FY25 Q1 development decision

Capital raisings wrap: Brainchip, Ovanti, Lake and VHM

NVA

Nova locks in NASDAQ US market listing at a value of only US$3.3M as ASX gets quieter and quieter

There are more pages in this discussion • 65 more messages in this thread...

First 328 Last

Add MSB (ASX) to my watchlist

(20min delay)
Last $1.13		Change -0.025(2.17%)		Mkt cap ! $1.284B

Open	High	Low	Value	Volume
$1.15	$1.16	$1.11	$7.363M	6.488M

Buyers (Bids)

No.	Vol.	Price($)
5	94863	$1.13

Sellers (Offers)

Price($)	Vol.	No.
$1.13	5000	2

View Market Depth

No.	Vol.	Price($)
4	85863	1.125
3	60500	1.120
3	49858	1.115
10	234700	1.110
3	20500	1.105

Price($)	Vol.	No.
1.130	1000	1
1.135	15000	2
1.140	10000	1
1.150	27892	3
1.155	25000	1

Last trade - 16.10pm 26/07/2024 (20 minute delay)

MSB (ASX) Chart

Very True, The FDA are certainly in no hurry to approve.On...

ASX Market Open: ASX200 to rise for Friday session | July 26

Tissue Repairs soars nearly 32% on TGA approval for wound healing gel

Red Hawk upgrades Blacksmith with DSO mineral resource at the Eagle Deposit

Monadelphous inks $200M contract with Woodside to help build Pluto LNG – but will it make Scarborough cheaper?

MinRes jumps 5% as the company meets production guidance – depressed iron ore prices be damned

Nine's staff strike as Paris Olympic coverage begins

IGO kicks off earn-in copper drilling on-site Encounter's Yeneena play as it adopts new identity

Horizon firms up ore reserve for Boorara ahead of FY25 Q1 development decision

Capital raisings wrap: Brainchip, Ovanti, Lake and VHM

Nova locks in NASDAQ US market listing at a value of only US$3.3M as ASX gets quieter and quieter

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Very True, The FDA are certainly in no hurry to approve.On...

Top Stories

ASX Market Open: ASX200 to rise for Friday session | July 26

Tissue Repairs soars nearly 32% on TGA approval for wound healing gel

Red Hawk upgrades Blacksmith with DSO mineral resource at the Eagle Deposit

Monadelphous inks $200M contract with Woodside to help build Pluto LNG – but will it make Scarborough cheaper?

MinRes jumps 5% as the company meets production guidance – depressed iron ore prices be damned

Nine's staff strike as Paris Olympic coverage begins

IGO kicks off earn-in copper drilling on-site Encounter's Yeneena play as it adopts new identity

Horizon firms up ore reserve for Boorara ahead of FY25 Q1 development decision

Capital raisings wrap: Brainchip, Ovanti, Lake and VHM

Nova locks in NASDAQ US market listing at a value of only US$3.3M as ASX gets quieter and quieter

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News