Blue bit:
https://www.nature.com/articles/s41591-020-1050-x
Yellow bit:
Dr Temple during the ODAC meeting 2020:
https://web.archive.org/web/20210305082200/https://www.fda.gov/media/143337/download
Essentially, you have a manufacturing process for your MSC-therapy, that could result in one specific product today which could result in a complete response, partial response or no response today, could result in a different outcome if the same manufacturing process is used a week later after an additional round of medications, or a year later due to age, or the same day depending on the origin of the MSCs (despite them all being MSCs). More information can also be found here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10453316/
Now with Cymerus you potentially have a process from start to end that could eliminate all these confounding factors, since the starting material will remain the same (cryo-preservation perhaps is something that should be closer looked into), and the manufacturing process also remains the same, today, tomorrow, next year, which makes it attractive in the eyes of Hunter, LUMC etc.
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