A better place to start...

First 150 Last

Share
Profile

Follow
LearningEachDay

5,708 Posts.

2050

24/06/24

01:32

Post #: 74450402
Share

Originally posted by LearningEachDay: ↑

Wow, you need to spend some time learning about the FDA approval process. MSB is applying for a BLA, Biologics License Application. Like all BLAs, it will be reviewed by FDA's Center for Biologics Evaluation and Research.

https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber

Sometimes during the review process, FDA will seek advice from outside experts in the form of an advisory committee. At FDA's request during the initial BLA review in 2020, the Oncology Drugs Advisory Committee (ODAC) looked at Ryoncil and and gave the opinion (9-1) that Ryoncil was effective at treating acute steroid resistent GVHD in children. The question wasn't "should we approve this drug," but most ODAC members would tell you that this is the real advice being given.

Despite this advice, FDA issued a CRL. And then another one in 2023. There won't be any advisory committees involved in the review this time. Just FDA CBER reviewers deciding if all remaining concerns have been addressed (product potency assays). And then final decision by the boss, Peter Marks. As we have seen this past week, he sometimes overrules the advice of these CBER reviewers.

Expand

A better place to start reading....

https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber

MSB Price at posting: $1.03 Sentiment: Buy Disclosure: Held
5 Upvote

1 Great analysis

Reply

Top Stories

Trimmed CPI figure provokes market jump of 1%, but inflation pressures remain a reality

MRC

Mineral Commodities to shut down Tormin mineral sands project as oil spill contaminates beach

KOB

Koba, formerly a cobalt player, gears up to become newest explorer in the uranium state: South Australia

MYE

Grosvenor mine fire takes another scalp as Metarock's 168-person presence on-site suspended by Anglo

MGU

New results confirm Buena Vista's iron grades potential

There are more pages in this discussion • 50 more messages in this thread...

First 150 Last

Add MSB (ASX) to my watchlist

(20min delay)
Last $1.02		Change 0.015(1.49%)		Mkt cap ! $1.153B

Open	High	Low	Value	Volume
$1.00	$1.03	94.0¢	$9.268M	9.466M

Buyers (Bids)

No.	Vol.	Price($)
10	33500	$1.02

Sellers (Offers)

Price($)	Vol.	No.
$1.03	28351	11

View Market Depth

No.	Vol.	Price($)
8	23296	1.025
15	86555	1.020
12	77450	1.015
13	279172	1.010
11	158618	1.005

Price($)	Vol.	No.
1.030	49730	10
1.035	179146	11
1.040	87596	10
1.045	42232	5
1.050	78201	6

Last trade - 14.23pm 31/07/2024 (20 minute delay)

MSB (ASX) Chart

A better place to start...

Trimmed CPI figure provokes market jump of 1%, but inflation pressures remain a reality

Mineral Commodities to shut down Tormin mineral sands project as oil spill contaminates beach

Koba, formerly a cobalt player, gears up to become newest explorer in the uranium state: South Australia

Grosvenor mine fire takes another scalp as Metarock's 168-person presence on-site suspended by Anglo

New results confirm Buena Vista's iron grades potential

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

A better place to start...

Top Stories

Trimmed CPI figure provokes market jump of 1%, but inflation pressures remain a reality

Mineral Commodities to shut down Tormin mineral sands project as oil spill contaminates beach

Koba, formerly a cobalt player, gears up to become newest explorer in the uranium state: South Australia

Grosvenor mine fire takes another scalp as Metarock's 168-person presence on-site suspended by Anglo

New results confirm Buena Vista's iron grades potential

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News