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Ann: Mesoblast Resubmits BLA with FDA for Ryoncil Approval, page-235

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reginaldp

2,929 Posts.

2059

12/07/24

11:21

Post #: 74723550
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Originally posted by JB1975: ↑

Not often but yes to ever. I kind of have to because I have to deal with (not just deal with - some people who I think are profoundly wrong about just about everything to do with policy or requiring longish chains of objective reasoning are family members for instance or community members - logic and reasoning isn't their strong suit but they do have virtues and I care about them and they care about me) other people that think what they have is somehow the truth and they are planning to act on that truth.

People read and listen to Murdoch media (or whatever media they want to) and get their biases confirmed to them over and over.

Biases - the belief that something is true when it is not is getting extremely serious in the world at the moment. The US Presidential election (the US supreme court have essentially given all future US Presidents (not just Trump any of them until the high court ruling is changed) the power to assassinate (and to order members of the military to assassinate and to then pardon them or have the guy next to them shoot them for failing to follow an order). The changing climate. In the time the planet has existed it has had extremes of climate far worse than 6% warming. There was a stage on earth where there was almost no oxygen in the air - life created the oxygen rich atmosphere. But at no stage in written human recorded history say 10,000 years of living in towns or cities on coastal regions for instance has there been big changes in temperature like 6 degrees hotter over the whole world - that can be about as impactful on human societies as an asteroid hitting the earth was on the dinosaurs.

A truth is, and this is coming back to Mesoblast, there is some merit in the work that MSB has done to get to a point where for the third time a BLA is being sought, (that's my opinion - but I'd bet my life on it being factually true - some merit) but there isn't (and I wouldn't bet my life on this) but I would want to discuss it because its important - there isn't quite enough merit in MSBs potency validation to give Mesblast a BLA in my opinion - that opinion of mine being based on the science and the data that is in the public domain - I think that public domain stuff is enough to make that call with a fairly high degree of confidence IF a person has enough science to understand what MSB has said and IF they are across the other material about MSB that is in the public domain. But here is the thing most people aren't across either the relevant science or the relevant information that is the public domain including most holders - I'd say including all holders that I see posting on this forum with an sort of frequency.

Now people can learn from each other if they'll listen - but listening and learning is not what many people want to do - what many people want to do is profit themselves. And they are willing in many cases to harm others as well to do such profiting.

That's the actual problem in getting truth based discussions on forums like this one -or in the world - the profit seekers out number the truth seekers. A person that starves before they have kids leaves no offspring. But as the tech gets more powerful the power for profit seekers to destroy profit seekers and truthseekers (and most of us a a bit of both) can get to the point where the world (the human world) can effectively destroy itself.

AI, nukes, bioweapons. there is buzzword unreality in some of those things but there is also reality. We've had two world wars, we have a COVID crisis globally, we've had wars on terror and 9/11. We've had weapons of mass destruction discover adventures into Iraq to find they weren't there -and then we've re-elected Bush, Blair and Howard because dead Iraqis families are no part of the voting constituency's of Bush, Blair and Howard - and its the economy stupid not the occasioning of mass murder through dumb intelligence and with media manipulation that matters for elections stupid. It was Clinton (Bill) who said its the economy stupid. The same Clinton who helped kill America's gag response and said depends on what the definition of is is and helped bring in, or continue the decline in confidence of people in their institutions.

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JB1975- the NEW DATA is not available in the public domain. You were correct - well done- on predicting the CRL.
All we know is below. I believe you had cast doubt upon Prof Kurtzbergs potency assay- what would have needed to be added to give you certainty? Can you predict what they may have achieved scientifically?
Something has changed- that's a fact

New data from second potency assay provided to FDA, meeting scheduled Q1 CY2024.

Graft versus Host Disease – Pediatric and Adult Indications
• United States Food and Drug Administration (FDA) informed Mesoblast after its Type C meeting
during the quarter that following additional consideration the available clinical data from its Phase 3
study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License
Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute
graft versus host disease (SR-aGVHD).
• Mesoblast intends to file the resubmission this quarter, potentially resulting in an approval for
Ryoncil® (remestemcel-L) in the second half of CY2024.
• Mesoblast will now focus on its original strategy to first gain pediatric approval for RYONCIL, followed
by label extension in the larger adult population.

Reg

MSB Price at posting: $1.14 Sentiment: Buy Disclosure: Held
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