Happy to be corrected but as far as I am aware, up to this point...

Happy to be corrected but as far as I am aware, up to this point the adult aGVHD trial has not been billed as a confirmatory trial, so there is nothing to suggest that the original BLA does not still stand and that the FDA were not in a position to give a traditional approval, if they were happy with the additional potency data already provided in Jan/Feb. Thankfully, all will be revealed at the upcoming FDA meeting. Since the agency have stopped talking about trial efficacy for children since reviewing the resubmission last year, and the extra potency assay data could very well close the final gap from their point of view (a sense of which having been clearly conveyed by the company in the recent ********* interview), there would clearly be no need to rely on surrogate endpoints to speed things up. It stands to reason that there is nothing to speed up to other than final approval, and I don’t think it is too far stretched or speculative to say that.

As for the adult trial, it would be very short from the point when recruitment is completed, simply because of the target patients who are refractory to other biologics and by definition very, very sick. No need for surrogate endpoints here.