It is more important to make the resubmission watertight than to satisfy impatient shareholders. In addition, the company is, not inconceivably, building a data and manufacturing process control moat around its product and iP that will make it basically unassailable. It is in this context that we should view the wait fir resubmission and time it takes. The process control draft FDA guidance published in late Dec 2023 had many mentions of the need for a risk controlled process. I suspect the CMC module being prepared for resubmission will be beefed up in order to satisfy all of these demands.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/potency-assurance-cellular-and-gene-therapy-products
It is more important to make the resubmission watertight than to...
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