MSB Trading - Aug 2020 on, page-556

First 556 Last

Share
Profile

Follow
zeeb0t

2,012 Posts.

565

11/08/20

08:42

Post #: 46441835
Share

Originally posted by kervio: ↑

Hi everyone, I've pulled out the important part of the FDA document for reading:

"As stated above, FDA’s position is that the analytical methods used for product characterization
of remestemcel-L do not have a demonstrated relationship with clinical outcomes. We ask the
committee to consider the product attributes identified by the Applicant as CQAs and discuss
whether they are adequate to ensure that the manufacturing process will produce lots of
consistent quality. Additionally, given the limitations of the current CQAs, and the state of
knowledge in the field of MSC, we ask that the committee discuss other product characteristics
not previously identified as CQAs for remestemcel-L that might provide more meaningful
measures of product quality and potency."

To break this down, the committee is looking for a way to ensure that the manufactured cells are going to be as effective as the cells that were proven clinically effective in the study. Their point of view is that because this area of medicine is so new, there are not adequate existing standards by which to test the quality of the cells, and therefore they don't want people getting ineffective cells and dying. Their recommendations are that they improve the testing of the product and discuss some better measures for identifying quality cells. This is undeniably a hurdle, but depending on the outcome of the discussion between MSB and FDA it could be a small hurdle or a big one. My personal level of concern is about 4 out of 10... I expect a retrace though today as people take profits and overreact to this news, but DYOR.

Expand

100% agree

MSB Price at posting: $4.87 Sentiment: Buy Disclosure: Held
2 Upvote

0 Great analysis

Reply

Top Stories

WR1

Winsome scoping study proposes low-cost operation for Adina lithium project

ALR

Altair Minerals hits high-grade copper and gold at Wee MacGregor, QLD

SNG

Siren Gold boosts antimony resource by 66% to 14.5Kt at Auld Creek, NZ

PTR

Petratherm adds $1.6 to the piggybank ahead of SA titanium drilling program

WMG

Western Mines identifies 2 high-grade zones at Mulga Tank in WA

There are more pages in this discussion • 1,829 more messages in this thread...

First 556 Last

Add MSB (ASX) to my watchlist

(20min delay)
Last 92.5¢		Change 0.005(0.54%)		Mkt cap ! $1.050B

Open	High	Low	Value	Volume
93.0¢	93.5¢	91.5¢	$1.180M	1.279M

Buyers (Bids)

No.	Vol.	Price($)
23	203234	92.0¢

Sellers (Offers)

Price($)	Vol.	No.
92.5¢	39577	31

View Market Depth

No.	Vol.	Price($)
23	203234	0.920
33	270577	0.915
19	266490	0.910
9	124467	0.905
45	292377	0.900

Price($)	Vol.	No.
0.925	39747	32
0.930	141006	21
0.935	12937	5
0.940	40129	6
0.945	135611	4

Last trade - 15.06pm 17/09/2024 (20 minute delay)

MSB (ASX) Chart

MSB Trading - Aug 2020 on, page-556

Winsome scoping study proposes low-cost operation for Adina lithium project

Altair Minerals hits high-grade copper and gold at Wee MacGregor, QLD

Siren Gold boosts antimony resource by 66% to 14.5Kt at Auld Creek, NZ

Petratherm adds $1.6 to the piggybank ahead of SA titanium drilling program

Western Mines identifies 2 high-grade zones at Mulga Tank in WA

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

MSB Trading - Aug 2020 on, page-556

Top Stories

Winsome scoping study proposes low-cost operation for Adina lithium project

Altair Minerals hits high-grade copper and gold at Wee MacGregor, QLD

Siren Gold boosts antimony resource by 66% to 14.5Kt at Auld Creek, NZ

Petratherm adds $1.6 to the piggybank ahead of SA titanium drilling program

Western Mines identifies 2 high-grade zones at Mulga Tank in WA

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News