"Take a moment to reconsider, especially because the FDA has now, after a changing of the guard, adopted MSB's approach to therapeutics."
That changing of the guard has happened, and guess what, it's just as whytee says, it's all about the data.
Also, the same changed guard was in position when MSB got knocked back.
Dr Califf, FDA Commissioner:
"Dr. Curfman: You brought up the issue of evidence, and I'd like to drill down on that a little bit more. As the FDA makes decisions about the safety and efficacy of novel therapies, the agency relies heavily on medical and scientific evidence to support the decisions. I wonder if you could please discuss how the quality of research evidence affects the FDA's decisions about product approvals.Dr. Califf: That's such an important point, Dr. Curfman. I'm glad to have a chance to talk about it. I do have a few quips about this one that I think should help people at least understand how I think about it, is a frequently used phrase about the FDA, in God we trust, all others must bring data. And so opinions are cheap and easy. But when really looking at the data and turning that into evidence that is applying a method to draw an inference about causation of an intervention, it's a really serious and difficult business that we struggle with every day, because all the evidence is not perfect."
Of course, SI/Kraus tried to be tricky and circumnavigate what FDA requested.LINK
"Mesoblast gives allogeneic cell therapy a 2nd try with FDA—but without a new trial
The new data and new application will compete against the FDA’s original request when the cell therapy was first rejected in October 2020, asking for at least one additional trial."
MSB Price at posting:
29.5¢ Sentiment: None Disclosure: Not Held
(20min delay)