This is not correct:
"Given that they can't start the back pain trial until after the FDA gives the green light on potency assays the only firm thing left within 3 months is the heart approach chat with the FDA."
Only the pivotal ARDS trial using Remestemcel-L has been halted pending potency assay.
The other trials are using a completely different product, so there cannot be a read accross of potency assays. The CHF or CLBP trial can get up and running any day.
I do like the idea of a partnering deal, and if 150 million ADR's are involved, that will be a whopper of a deal indeed.
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-573
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