After reading up more on Marks, I consider it to be a bit of...

After reading up more on Marks, I consider it to be a bit of confirmation bias since he is not "new", he joined the FDA in 2016 and has been the Director of CBER since 2016. His January 2024 interview in BioSpace, if taken apart, could be read as:
"Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, argued that non-randomized, single-arm trials could be the best option when testing certain gene therapies for rare diseases"
"“There are many rare diseases affecting dozens to a few hundred individuals in the United States where the concept of trying to do a randomized trial is very challenging at best and impossible at worst,” Marks told BioSpace. When it comes to trialing gene therapies, it’s not possible to efficiently enroll sufficient numbers of patients, either because there aren’t enough patients or because those patients won’t agree to be randomized, he explained. “It’s a situation where you can’t get the job done.”"

He however also said that:
"Marks concurred, saying that one of two conditions needs to be met for CBER to consider approval of a gene therapy based on a single-arm trial. “The treatment has to create a large enough effect that it is apparent to a non-statistician that something has happened significantly to those individuals, such that having a control group is not necessary,” he explained, or measurement tools must show that “a parameter has changed enough so that we feel comfortable that it is reasonably likely to predict that something good down the line is going to happen.”"
https://www.biospace.com/article/fda-s-marks-advocates-for-flexibility-in-rare-disease-gene-therapy-trials/

Question is, has MSB done that?

https://www.listcorp.com/asx/msb/mesoblast-limited/news/corporate-presentation-3039318.html

What does the non-statistician in you say? Survival of 67% vs 20-30% by 100 days, and what appears to be an improved potency assay as outlined above in the pending patents that has data to show from various previous trials (original manufacturing and improved manufacturing methods)?
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I've jumped over the patent application to deal with this next as its easier (the patent application is the most important in my opinion (going to your can MSB get a BLA) so I;ll come back to it).

Your links are good - Marks speaking in 2024 is speaking currently - good. I understand Marks talking about effects being so clear that even biostatistician can see then or being so great so obvious that the biostatisticians don't need to look. And I understand that a number like 67percent looks to any regular joe to be much better than a number of 10, 20 30ish percent - so if I didn't have problems in the patent application section of your post and if the science was a black box to me so I was trusting Silviu without having doubts come at me through the opaque walls of what some see as a black box, then I think I'd agree with you.

So I think all that remains differing between you and I is the substance of the science in patent application where IL2Ralpha is bring wrestled over.