https://www.fda.gov/media/170457/download
Fascinating reading .
Latindra's approval summary.
It's an allogeneic cellular therapy using organ donors.
The full process of the FDA' s BLA timeline is laid out,
Meso is now at the end of this process
@whytee each treatment is a one off from a different donor, potency issues, safety issues, single arm open label trial and was
for an unmet need. Klinker was part of the approval process. Oh and they had a CRL too.
TICKEST TOCKEST
Reg
Cell Therapy News/Articles, page-16634
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