MSB

4.07%

$1.15 mesoblast limited

Ann: Mesoblast Type A Meeting with FDA, page-56

First 56 Last

Share
Profile

Follow
Bigdaddio

142 Posts.

16

21/09/23

13:30

Post #: 69957751
Share

Originally posted by bedger: ↑

Contrary to many of the posts above I believe there is actually some real inconsistency here. Krause very clearly said in the recent post CRL conference that the FDA did not question efficacy:

"one of the significant positive indicators from the CRL - is that the CRL did not question the efficacy of the product as demonstrated in GvHD001, (which was the case for the previous CRL )" (Krause, 31 Aug 2023)

But then in this update:

"FDA noted that the lack of a suitable potency assay for the RYONCIL product used during the Phase 3 trial MSB-GVHD001 for the pediatric acute GVHD indication has prevented the trial from being considered an adequate study for the purpose of demonstrating substantial evidence of effectiveness required for a marketing approval."

If they didn't accept the potency assay, then they didn't in fact accept the efficacy as demonstrated by GVHD0001.

Perhaps I am wrong, but I think Silviu and Krause, are loudly here setting out the inconsistencies they are dealing with from the FDA themselves, for all too see, and showing all how they are arguing with the FDA on the validity of the potency assay and adding ever more data to back their claim and refute the contentions of the FDA, which they are showing as inconsistent and are picking away at.

"FDA indicated its willingness to consider Mesoblast’s proposed registrational trial design in adults, subject to agreement on the suitability of the potency assay for the product to be used in adults."

Clearly they are making some difficult progress on the potency assays with the FDA, both past used and those going forward and can't jeopardize that too much by too loudly pointing out FDA inconsistency, which has been shown innumerable times in other treatment decisions/processing by the FDA.

(happy be corrected by more informed MSB posters - not the peanut brigade)

Expand

Agreed - mega piss take going on here.

Just reread the BLA resubmission announcement from 1Feb which states MSB submitted new “validated potency assays” for the product used in the 54 patience study.

MSB Price at posting: 37.0¢ Sentiment: Hold Disclosure: Held
7 Upvote

0 Great analysis

Reply

Top Stories

GNX

NSW approves J-POWER's $380M buyout of Genex Power, giving it ownership of QLD net zero project

AI stocks: What to expect in 2024-25

Talking Australia's very competitive property landscape: Realty Talks

Warren Tredrea’s weekly sports business wrap: the latest on business in sport

Wealth Within considers potential takeover targets in Australia's booming infrastructure industry

Week 29 Wrap: Trump in spotlight again; China's Third Plenum a yawnfest; RBA's August move a mystery

FG1

Flynn Gold flags mid-grade drill hits and always eye-catching rock chips

IMR

Imricor raises $35M to pursue growth and expansion into Australia and NZ

LKE

Lake Resources implies news article on job cuts made up; non-core sales "not material" and no rule 15.7 breach

MCT

Metalicity looking for offers on Admiral Bay zinc project

There are more pages in this discussion • 519 more messages in this thread...

First 56 Last

Add MSB (ASX) to my watchlist

(20min delay)
Last $1.15		Change 0.045(4.07%)		Mkt cap ! $1.313B

Open	High	Low	Value	Volume
$1.08	$1.16	$1.08	$4.681M	4.170M

Buyers (Bids)

No.	Vol.	Price($)
1	99680	$1.15

Sellers (Offers)

Price($)	Vol.	No.
$1.16	31000	2

View Market Depth

No.	Vol.	Price($)
1	99680	1.150
4	178484	1.145
3	40155	1.140
1	23155	1.135
3	88145	1.130

Price($)	Vol.	No.
1.155	31000	2
1.160	77919	3
1.165	2000	1
1.170	45455	3
1.175	49449	5

Last trade - 16.10pm 19/07/2024 (20 minute delay)

MSB (ASX) Chart

Ann: Mesoblast Type A Meeting with FDA, page-56

NSW approves J-POWER's $380M buyout of Genex Power, giving it ownership of QLD net zero project

AI stocks: What to expect in 2024-25

Talking Australia's very competitive property landscape: Realty Talks

Warren Tredrea’s weekly sports business wrap: the latest on business in sport

Wealth Within considers potential takeover targets in Australia's booming infrastructure industry

Week 29 Wrap: Trump in spotlight again; China's Third Plenum a yawnfest; RBA's August move a mystery

Flynn Gold flags mid-grade drill hits and always eye-catching rock chips

Imricor raises $35M to pursue growth and expansion into Australia and NZ

Lake Resources implies news article on job cuts made up; non-core sales "not material" and no rule 15.7 breach

Metalicity looking for offers on Admiral Bay zinc project

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Ann: Mesoblast Type A Meeting with FDA, page-56

Top Stories

NSW approves J-POWER's $380M buyout of Genex Power, giving it ownership of QLD net zero project

AI stocks: What to expect in 2024-25

Talking Australia's very competitive property landscape: Realty Talks

Warren Tredrea’s weekly sports business wrap: the latest on business in sport

Wealth Within considers potential takeover targets in Australia's booming infrastructure industry

Week 29 Wrap: Trump in spotlight again; China's Third Plenum a yawnfest; RBA's August move a mystery

Flynn Gold flags mid-grade drill hits and always eye-catching rock chips

Imricor raises $35M to pursue growth and expansion into Australia and NZ

Lake Resources implies news article on job cuts made up; non-core sales "not material" and no rule 15.7 breach

Metalicity looking for offers on Admiral Bay zinc project

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News