I've had a listen to the podcast and looked into this in a preliminary way.
It sounds to me as if the US FDA is just skimming around the issues and delaying for reasons which are not clear either to themselves or something else is going on. I won't speculate on this in any depth.
The FDA are asking about the identification and use of predictive markers or indicators of susceptibility to the inflammatory storms, which are not conclusive at this point.
This is a peripheral issue.
It's so bizarre to have made it the central issue that clearly the MSB lawyers are onto it and they are so confident that Silviu Itescu and Prof Grossman are openly talking about their next moves and about their level of confidence.
When asked if they can force the meeting which is being foreshadowed, SI indicated that the answer is 'yes'.
This means the obligation to hold the meeting is set out under legislation. In the US it is possible to force a government body to perform an action or desist from an action, according to the relevant duties and obligations. They cannot neglect to hold the meeting. The power to force it is called a 'mandamus' enforced in the courts.
Knowing that MSB can seek to have their right to the meeting enforced in the courts, the FDA is expected to comply. (In Australia it's limited to the actions or obligations of a Minister).
The reason that SI and Grossman are so confident is the logic of their case IMO. In fact, the argument to approve is so reasonable, and withholding approval so unreasonable, as to be absurd. (My words not theirs). They have been very controlled in what they say, but it's possible to detect something like suppressed outrage and incredulity simmering below the surface. They are of course, each unfailingly polite. As you would expect. They want to win and they have their eyes on the main game. Human life. IMO
In the British/Australian legal system the FDA letter might be traditionally characterised as Wednesbury unreasonableness: a decision which has been exercised in a way that 'is so unreasonable that no reasonable person could have so exercised the power'.
This is the sting. Sure the inflammatory markers are potentially useful as a predictive tool, it's obviously why MSB has been observing them. But they're peripheral to the core driver of curing the children; keeping them alive. The reality of the success of remestemcel-L is clear.
The argument is that it's unreasonable to try to compel a double blind study in children to extract these indicators. It's pointless because it would cause unnecessary suffering and deaths and still be inconclusive. The only conclusive way of establishing the sought after predictive markers is for an adult trial conducted as a follow-up. This is what the MSB team propose and appear so sure of winning, because ultimately it's about the key aims and results. Not peripheral issues.
It's also about having grounds for judicial review of a refusal or a demand. This hangs over the right to have the meeting held and the arguments heard and appropriate weight being given to the medical evidence. If the US FDA don't make a logical, proportionate and reasonable decision taking all relevant information into account, MSB can have that decision overturned and more importantly, replaced with a new one.
In other words this is ramping up a notch and the US is a highly litigious environment. Technically at the background the USFDA could become subject to judicial review for abuse of discretion, that's how I read it. Others might think the FDA are just being cautious and there is no such danger.
These are my opinions only from what I concluded from the webinar. I urge everyone to listen to it.
It's not investment advice; it's an exploration of the legal issues as I see them. It's not legal advice either. People are free to explore what I've said and listen to the webinar with those pointers in mind, and research the FDA legislation themselves and the points I raise themselves. I haven't gone that far to dig up the precedents and trawl through the legislation because life is too short for that right now.
Litigation is not being run. Yet. That's not the point. MSB is making their next move and it's fearless.
I do not have any part of this whatsoever nor any access to it. I'm just looking at the logic of what's being fed into the legal structure as I understand it and what I know from the broad structure of US administrative law, which is actually stronger than our system IMO.
SI says there are many legal precedents for the line that MSB are running. I believe him.
What is also clear is the Legal team at MSB is energised and ready to go. I have full trust in them.
Even though the US federal courts may appear to be stacked with conservatives, (and if it does get to the courts which is unlikely, I think this could be just a move in a chess game) the reality is they won't all vote the same on every issue. I'm holding tight and trusting in a sensible outcome.
It's possible the US FDA are simply unable to comprehend what they're looking at. Or they think we're a bunch of hillbillies from Awstraya with no idea.
SI and team will enlighten them.
All IMO.
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