MSB to dispute FDA finding in Type A meeting, page-108

First 108 Last

Share
Profile

Follow
anf0

1,971 Posts.

187

02/10/20

19:23

Post #: 47821470
Share

Originally posted by Zenox: ↑

It is definitely probable Mesoblast and the FDA entered into some type of correspondence following the ODAC meeting, but these would not have been formal or detailed discussions.

It appears the FDA went with their original stance and ignored the recommendation of the ODAC committee, expert testimony, and the clinical benefit to children. It seems the FDA simultaneously applied a low threshold for rejection and a high threshold for approval. Maybe the current political climate played a role since there has been some serious scrutiny surrounding the FDA in the last few months, and September has been a particularly bad month for approvals. Maybe the petition from Lassman Law play a part as well. Overall it seems the FDA believes Ryoncil just missed the regulatory requirements for approval.

The best way I can explain the FDA approval process is to use an example where a patient goes into a hospital to see a doctor. Normally they will see a lower ranked doctor first (let's say a trainee or a registrar), who are the first to evaluate the patient. The registrar will consult other specialists to obtain an accurate assessment of the patient (or in this case Mesoblast's BLA application) and they will make a diagnosis (approval or not). Sometimes the diagnosis will be in dispute and the case will be escalated to the consultant (highest ranking doctor) who will make a more informed assessment of the patients condition.

Mesoblast have a clear case to take to the FDA to dispute this decision and there are precedents that work in their favour. As I understand it, Mesoblast will need to submit an application containing key information supporting approval (this cannot include new information) and this will be viewed by those higher up in the chain of command who will have to apply precedents to their decision making. The key difference here is they need to apply precedents. Today's CRL leads me to believe that the FDA does not want to set a new precedent by approving Ryoncil, but following a Type A meeting they can apply other precedents to facilitate approval. As SI said today, this is just part of a process.

Should we be concerned? No not yet. Maybe if they deny the Type A meeting, then sure. But even then, we still have COVID ARDs, CLBP and Heart readouts to come - all blockbusters.

Expand

I encourage you to read this if you’re truly interested in the facts. It’s by far the best analysis on this treatment I’ve seen, and just to warn you it tilts against FDA approval.

https://mobile.twitter.com/BiotechSacred/status/1293897790557425664

And FYI I shared it during the ODAC meeting and got obliterated from every direction. I was just trying to share some important information.

Last edited by anf0: 02/10/20

MSB Price at posting: $3.19 Sentiment: Sell Disclosure: Not Held
6 Upvote

0 Great analysis

Reply

Top Stories

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

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

There are more pages in this discussion • 910 more messages in this thread...

First 108 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¢	$1.473M	1.596M

Buyers (Bids)

No.	Vol.	Price($)
1	32370	92.5¢

Sellers (Offers)

Price($)	Vol.	No.
93.0¢	60258	5

View Market Depth

No.	Vol.	Price($)
1	32370	0.925
9	98847	0.920
20	130822	0.915
15	194562	0.910
7	97027	0.905

Price($)	Vol.	No.
0.930	60258	5
0.935	28119	2
0.940	20797	3
0.945	59774	3
0.950	26619	3

Last trade - 16.10pm 17/09/2024 (20 minute delay)

MSB (ASX) Chart

MSB to dispute FDA finding in Type A meeting, page-108

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

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

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

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

MSB to dispute FDA finding in Type A meeting, page-108

Top Stories

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

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

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

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News