banter and General Discussion, page-8356

I imagine that the critical path through FDA's new and evolving cellular treatment methodology directly pertains to the alignment of the potency assay matrix with the MOA (Method Of Action). The FDA can wring their hands till the cows come home over MOA, and kick the cow down the road into the long BigPharma grass if they feel so inclined while complex systems are teased out.

The challenge for MSB is to actively mature a product specific potency assay matrix demonstrably linked to positive clinical outcomes so that, IRRESPECTIVE of settling the MOA question, cell batch + potency + clinical result are causally bound to FDA satisfaction.

If negotiations leave the door open to delay due to MOA doubt that is an issue, however the spirit of the new guidance document looks like directly addressing this quandry (for some) and clearly MSB are striving to make a cellular treatment SOC with effective products saving lives and relieving/curing affliction + disease sensible way forward for FDA. We'll know within 3 months if the tide has turned.