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$1.07 mesoblast limited

Is the new potency data acceptable? Yes- it is sufficient-...

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whytee

16,588 Posts.

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16/05/24

14:22

Post #: 73858665
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Originally posted by reginaldp ↑

https://www.lw.com/admin/upload/Sit...llingness-to-Engage-Industry-Stakeholders.pdf

Conclusions
The Draft Guidance expands opportunities for industry to meet with FDA, reflecting the terms that FDA and
industry stakeholders agreed to during PDUFA VII negotiations. Specifically, the Draft Guidance provides
PDUFA sponsors and applicants with additional meeting types, reorganizes the formats of meetings, and
provides opportunities to ask clarifying questions when interacting with the Agency regarding a meeting. In
addition to these changes, FDA has also increased options for interaction between the Agency and other
stakeholders through recent updates to other draft and final guidance documents.

Chief medical officer perhaps got some clarification

The scenario below is fiction

Is the new potency data acceptable? Yes- it is sufficient- please refile your BLA

What are the chances that question was asked?

Reg

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Is the new potency data acceptable? Yes- it is sufficient- please refile your BLA
What are the chances that question was asked?

Zero. Nil. Because if the FDA had stated that to Mesoblast, SI would have trumpeted in every media outlet.

MSB Price at posting: $1.03 Sentiment: Sell Disclosure: Not Held
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0 Great analysis

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(20min delay)
Last $1.07		Change -0.060(5.33%)		Mkt cap ! $1.216B

Open	High	Low	Value	Volume
$1.14	$1.14	$1.07	$5.556M	5.065M

Buyers (Bids)

No.	Vol.	Price($)
12	193123	$1.06

Sellers (Offers)

Price($)	Vol.	No.
$1.07	300057	2

View Market Depth

No.	Vol.	Price($)
12	193123	1.060
7	387603	1.055
19	117640	1.050
3	33950	1.045
5	42002	1.040

Price($)	Vol.	No.
1.070	300057	2
1.075	10000	1
1.085	100209	3
1.090	22209	1
1.095	22315	2

Last trade - 16.10pm 05/06/2024 (20 minute delay)


Last $1.07			Change -0.060 ( 5.22 %)
Open	High		Low	Volume
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Last updated 15.59pm 05/06/2024 ?

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