Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-1005

First 1005 Last

Share
Profile

Follow
LearningEachDay

5,902 Posts.

2124

13/07/23

03:48

Post #: 68758890
Share

Originally posted by whytee: ↑

Lets look at your statements from a rational perspective

"The FDA are in charge of approvals, not random petitions"

1. Yes the FDA are in charge of the approvals, and the petition doesn't change that. Actually by petitioning the FDA over the BLA application they are actually acknowledging that authority.

2. The petition isn't random. It's a petition from a commercial competitor that reminds the FDA of previous statements they made in relation to the original Remestemcel BLA

"They have their own processes , checks and balances that need to be followed... They will review the BLA in accordance with regulatory practices"
Yes agreed. The FDA should and likely will follow their normal regulatory evaluation process without fear or favour.

" If there are any valid points in the petition, they would have already been looked at by the FDA as part of the review, and approval will answer any questions the petition may have created."

That being the case then there would be no reason to be upset about the petitiion, it simply goes over previous points made by the FDA during the last BLA. If any of the points are valid they will be taken into consideration. An entirely reasonable statement although I'm not to sure about the "already" bit. The review is likely still current.

"As you can see the petition is literally full of confounded questions that make no sense whatsoever, and baseless accusations made by someone who is not privileged to even know what has been done as part of BLA"

Now here's where you really go off the rails with "full of confounded questions that make no sense" and "baseles accusations". You don't really want to leave it up the the FDA, just to make sure you take the shot gun out and trigger both barrels. You actually want to offer a completely negative and extreme opinion about the content of the petition...

But it doesn't matter a bit. You're playing to your own audience on HC and the FDA will make its own decision.

Expand

" The review is likely still current."

No. 3 weeks away, the review is complete. The decision is made. What is left is either documenting the reasons for the denial, or finalizing the label and preparing the press release.

MSB Price at posting: $1.25 Sentiment: Buy Disclosure: Held
12 Upvote

3 Great analysis

Reply

Top Stories

LU7

The Breakdown: Lithium Universe talks refinery design and lithium processing in strong preliminary feasibility study for Bécancour

STK

Rogozna grows with gold equivalent grading 1.1g/t across 545.7m for Strickland

TTT

Titomic jumps +6% as it incorporates Microsoft Hololens tech

AHK

Ark Mines provides strategic update following mining lease submission

RCE

Recce progresses testing of gel to treat bacterial skin infections

There are more pages in this discussion • 3 more messages in this thread...

First 1005 Last

Add MSB (ASX) to my watchlist

(20min delay)
Last $1.39		Change -0.075(5.12%)		Mkt cap ! $1.587B

Open	High	Low	Value	Volume
$1.45	$1.46	$1.37	$9.337M	6.672M

Buyers (Bids)

No.	Vol.	Price($)
2	80200	$1.39

Sellers (Offers)

Price($)	Vol.	No.
$1.40	28642	2

View Market Depth

No.	Vol.	Price($)
2	80200	1.390
1	14000	1.385
4	23290	1.380
3	91742	1.375
12	87705	1.370

Price($)	Vol.	No.
1.395	28642	2
1.400	24618	11
1.405	23636	1
1.410	81815	3
1.415	23636	1

Last trade - 16.10pm 09/10/2024 (20 minute delay)

MSB (ASX) Chart

Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-1005

The Breakdown: Lithium Universe talks refinery design and lithium processing in strong preliminary feasibility study for Bécancour

Rogozna grows with gold equivalent grading 1.1g/t across 545.7m for Strickland

Titomic jumps +6% as it incorporates Microsoft Hololens tech

Ark Mines provides strategic update following mining lease submission

Recce progresses testing of gel to treat bacterial skin infections

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-1005

Top Stories

The Breakdown: Lithium Universe talks refinery design and lithium processing in strong preliminary feasibility study for Bécancour

Rogozna grows with gold equivalent grading 1.1g/t across 545.7m for Strickland

Titomic jumps +6% as it incorporates Microsoft Hololens tech

Ark Mines provides strategic update following mining lease submission

Recce progresses testing of gel to treat bacterial skin infections

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News