My major point of concern would be the final paragraph on page 32 of the FDA (PM) draft. ( https://www.fda.gov/media/140986/download )
"Is an additional clinical trial in the SR-aGVHD population required for confirmation of the effectiveness of the product? What trial design trial would be required to provide evidence of effectiveness in this indication?"
To me, this could be suggesting the need for an additional trial? to further back up the data presented in the one-arm study.
This wouldn't be a decline as such, but it would stretch the time span required for an approval by at least another year.
This should be of no major concern to long term holders.
Bring on Friday! GLTAH
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-500
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