“This has been a rolling submission and the OTP has had plenty of time to opine on the additional potency assay should it really have not been fit for purpose. A Class 2 is anything from 2 months UP to 6 months, but as so many key parts have already passed review, such as manufacturing PLI, safety, efficacy and advisory panel, I would be surprised if this is not all wrapped up by early November because the resubmission is supposed to focus primarily on the outstanding items from the previous submission plus about a month to agree labelling and post approval commitments.”
Re-posting above because what you said is worth reminding what you describe correctly as “exhausted holders” of.
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-320
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