"You will find that the outstanding item is the potency assays - there are no questions on efficacy - full stop
If you pause and think a little, that's a claim made by Mesoblast. But the FDA didn't say there were no efficay concerns. What they said was without a properpotency assay, it's not possible to deremine efficacy. Basically the process of evaluation of efficacy stopped at an earlier step as far as the FDA was concerned. I'm not at all sure that if SI is proposing another single arm open label trial it will truly address the FDA's recommended pathway to approval, and how ell they will accept it remains to be seen.
Cell Therapy News/Articles, page-17242
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