So the FDA are dishing out RTF's like candy but at the same time the FDA requested that Mesoblast provide a formal submission to FDA of the detailed analyses of outcomes in high-risk HFrEF patients with diabetes and/or myocardial ischemia so that they can agree on a potential pathway to approval.... these two scenarios appear to be at opposite ends of the spectrum
..... bodes well for the FDA's confidence in Rexlemestrocel-L to treat the patient cohort outlined above IMO
GLTAH
MSB $1 Party, page-783
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