Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-968

I agree Whytee- it could be misconstrued. It is important that we all be clear in this hurried world of ours. Much like when you referenced " further long term survival data" would not be considered by the FDA , when the facts were they made reference to survival endpoints in trial design.

The resubmission has been accepted for potential approval.
The 4 year survival data for an unmet need is a cornerstone
of the resubmission.

Cyp is announcing two year survival results being presented at a conference , two years after the original announcement.


Makes me think they're important in this field of work.

I'm also betting my left nut that the potency assays were dealt with
prior to the acceptance of the resubmission. That little package that dropped into the FDA at the start of October with a price sensitive announcement.

Any hoo - you keep punchin - keep em honest



Reg