Also in that publication The future of accelerated approval for...

Also in that publication
The future of accelerated approval for FDA's Marks? More rare disease drugs and no 'hanging chads'.

https://www.fiercebiotech.com/biotech/peter-marks-says-fda-now-has-better-sense-rare-disease-biomarkers-will-more-accelerated


maybe the FDA is lining meso up for accelerated approval on other products once sragvhd is approved, also mentions confirmatory trials.

"im sure surrogate endpoints has been discussed before
One of the ways that can happen is through accelerated approvals, a regulatory pathway whereby drug developers get earlier approval based on data that's likely to predict clinical benefit for serious conditions. Those data points, called surrogate endpoints or biomarkers, differ depending on the disease, but are easier to accrue than clinical endpoints. "


" A critical facet of accelerated approval is confirmatory trials that are meant to ultimately prove that the surrogate endpoint will translate to genuine clinical benefit. FDA Commissioner Robert Califf, M.D., has successfully advocated to have those trials underway before companies get accelerated approval, a policy that Marks says is a "work in progress."