"U.S. FDA has informed the company 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)." So the assay prevented the study from being adequate.
Yes.
MSB provided more assay data and had a meeting with FDA about assays. Now the FDA says the study appears sufficient to support resubmission.
If you don't look at all the MSB provided evidence (if you won't review what Silvu himself said in the Hidden Gems video - where you can hear the words from his mouth - and if you won't go into the patent application - then you will remain free to speculate about what that data might be - but if you do look at Hidden Gems - you will see they did not provide new blood from new patients (which really would be new data in my opinion - it may or may not be confounded depending on how it was taken - but it would be new data - as would data from an adult trial - there is no argument from me about that).
Could it be that FDA's review of the new assay data has led them to look more favorably upon the study?
I have said before LED humans make mistakes. Not just individuals high courts too have reversed themselves - it is extremely rare that powerful bodies that don't have to change their mind - so often they can just choose to change the subject - do - but it can happen. It especially can happen if the personnel change - which is one reason why Presidential appointments to the US Supreme Court as so wrestled over - change the Highest Courts personnel you might indeed get a different result with the new court.
So yes personnel changes can give you a reduction in competency - absolutely. Its possible. It also possible for High Court Judges so I suppose FDA officials to be corrupted. There is a case in Australia of a High Court judge being corrupted. Its rare but it happens.
Apparently in ancient Rome a bunch of senators stood around whilst Caligula married his horse. Humans will do nearly amazing things a) if they have power and b) to stay onside with those who are crazy yet empowered. I doubt those in attendance at the weeding were wanting to kiss the bride.
Now I only say those things for completeness and fairness - because what actually matters is that the quality of the evidence is such that most sufficiently smart people can see that other sufficiently smart people acting ethically and with the same sufficiently deep knowledge of either the law or off the science will draw the same conclusions.
Its not like all data is equal - its not like you can't try to unpack the data. I am sure you understand that new blood from new patients would be a different sort of data than going back to an old experiment and redoing some statistical analysis on it - what matters, reasonably, is the nature of the data.
Just connecting dots.
Like Bazsa was connecting dots? Like otherperspective was showing what patents he had in mind?
If you do go back to that figure with 11 dots on it - bazsa suggested what was important was what was missing (but I think bazsa had embarrassed himself frankly) - but there is a sense in which he is partly right even with respect to those 11 dots - one of them had absolutely no improvement in T cell levels in the blood, another had almost no improvement leaving 9 others - but I don't think that's the thing that's missing that bazra wants me to see. Maybe its a half carrot from santa's reindeer or something.
(20min delay)