MSB (ASX) Mesoblast stock(rock)-take March 2024

Originally posted by stockrock: ↑

Below is how the FDA defines a Class 1 resubmission... and why some are suggesting a 2 month review.

Class 1 Resubmission — A resubmission that includes one or more of the following items:

1. Final printed labeling

2. Draft labeling

3. Safety updates submitted in the same format, including tabulations, as the original safety submission with new data and changes highlighted (except
when large amounts of new information, including important new adverse experiences, not previously reported with the product are presented in the resubmission)

4. Stability updates to support provisional or final dating periods

5. Discussions of postmarketing requirements/commitments, including proposals or protocols for such requirements/commitments

6. Assay validation data

7. Final release testing on the last 1 to 2 lots used to support approval

8. A minor re-analysis of data previously submitted to the application (determined by CDER as fitting the Class 1 category)

9. Other minor clarifying information (determined by CDER as fitting the Class 1 category)

In addition, here is a brief side by side comparison FDA draft guidance on the topic of "Meeting the substantial evidence standard based on one adequate and well controlled clinical investigation plus confirmatory evidence"
of confirmatory evidence "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products"
Dec19 FDA Draft Guidance "Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence"
Sep23 FDA Draft Guidance, which complements the Dec19 FDA Draft Guidance
1 Adequate and well-controlled clinical investigations in a related disease area Yes Yes
2 Certain types of real world evidence, such as extensive data on outcomes that provide further support for the lack of effect seen in the control group in the randomised trial Yes Yes
3 Compelling mechanistic evidence in the setting of a well-understood disease pathophysiology Yes Yes
4 Well-documented natural history of disease Yes Yes
5 Evidence from a relevant animal model Not mentioned Yes
6 Evidence from other members of the same pharmacological class Yes Yes
7 Evidence from Expanded Access Use Not mentioned Yes
8

Where Mesoblast were trying to present EAP data in the past to demonstrate both the mechanism of action, as well as efficacy, the FDA essentially ignored it due to "confounding factors" and did not treat is as confirmatory clinical evidence.

This is dispite the 240+ patient data submitted back in 2020, and likely many more by now ... all of this was essentially ignored by the FDA.

Fast forward to September 2023, and all the EAP data submitted by MSB suddenly became acceptable confirmatory trial data, provided that the FDA deemed it to be of sufficient quantity and quality... the status of this data may well have been elevated overnight from 'junk status' to 'treasury trove of clinical evidence' .

A subtle update by the FDA, which I believe has allowed the FDA to find the grounds it needed to accept Mesoblast's clinical data set provided to date.

goodluck all
Expand
Nice work, SR.

Your quote below just triggered me on the Heindrick (forget his name) guy who was the main anti MSB participant in the ODAC meeting stating along the lines that the 'EAP data was just a collection of anecdotes, not clinical data'. So how come now it is being accepted as some form of valid clinical data? Because it always was due to its strength of analysis, size and effect when compared validly against similar cohorts outside the EAP. Heindrick has been shown up for the backward dufus he always was, along with many commentators on this board, who obsess over arbitrary rules, instead of data driven thinking. Well those arbitrary rules have now changed, so do they stick to their ideology? Most likely because that is how fanatics live their lives. Enjoy your paper profits!

This is dispite the 240+ patient data submitted back in 2020, and likely many more by now ... all of this was essentially ignored by the FDA.

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Last 98.0¢		Change 0.010(1.03%)		Mkt cap ! $1.118B

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96.0¢	99.0¢	95.5¢	$5.286M	5.409M

Mesoblast stock(rock)-take March 2024, page-126

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	of confirmatory evidence	"Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products" Dec19 FDA Draft Guidance	"Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence" Sep23 FDA Draft Guidance, which complements the Dec19 FDA Draft Guidance
1	Adequate and well-controlled clinical investigations in a related disease area	Yes	Yes
2	Certain types of real world evidence, such as extensive data on outcomes that provide further support for the lack of effect seen in the control group in the randomised trial	Yes	Yes
3	Compelling mechanistic evidence in the setting of a well-understood disease pathophysiology	Yes	Yes
4	Well-documented natural history of disease	Yes	Yes
5	Evidence from a relevant animal model	Not mentioned	Yes
6	Evidence from other members of the same pharmacological class	Yes	Yes
7	Evidence from Expanded Access Use	Not mentioned	Yes
8

Mesoblast stock(rock)-take March 2024, page-126

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