...extract from the disclosure info Page 1....
"The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office."
...just saying...interesting
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- BLA 125706 Remestemcel-L FDA briefing document
BLA 125706 Remestemcel-L FDA briefing document
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All the Event Materials are here:
https://www.fda.gov/advisory-committees/advisory-committee-calendar/august-13-2020-meeting-oncologic-drugs-advisory-committee-meeting-announcement-08132020-08132020#event-materials
They speak for themselves.
GLTAH!
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