@whytee The FDA is making it up as they go along. Without proper consideration as to the fact of safety, and that the patient cohort are on their last legs and utterly without alternative remedies, and 80% mortality which is reversed with remestemcel.
Fair? FAIR TO WHOM? Certainly not the patients!!!
They're putting lead in the saddle to delay and obfuscate presumably to make it easier for competitors to MSB to catch up.
This is far less predictable than the Melbourne Cup. Frankly It stinks a bit like the Fine Cotton ring-in but the facts of course are a total inversion as the regulator in that case did the right thing.
JIMO.
CEO Itescu needs to go, page-148
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