No, it is still a problem that hasn’t been resolved.
For paediatric SR-aGvHD, the FDA are prepared to ignore it as there is no alternative and the kids will otherwise likely die. But read the BLA approval letter - there are still questions relating to the CQA’s of these bone-marrow derived products:
Mesoblast will run into problems when going for approval in larger indications. Cynata’s iPSCs are the solution.
CYP Price at posting:
24.5¢ Sentiment: Buy Disclosure: Held
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