Please remember that CRL tend to come with an approval, once concerns are answered. Which has been shown by another poster. I think we all suspected this as an outcome. But please remember FDA has NOT rejected. Type A means 2-3 months. And Mesoblast will urgently request a
Type A meeting with the FDA, expected within 30 days, to discuss a potential accelerated approval with a
post-approval condition for an additional study.
Hang on the ride is going to be steep today.
Please remember that CRL tend to come with an approval, once...
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